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Papers in this Session
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Ocular Surface Flora Changes Prior to Cataract Surgery with and without Use of Pre-Operative Topical Moxifloxacin
Authors
Caroline W. Wilson, MD
Daniel C. Terveen, MD
Jaclyn M. Haugsdal, MD, ABO
Thomas A. Oetting, MD
Purpose
To investigate how the pre-operative use of topical moxifloxacin prior to cataract surgery affects the ocular surface flora, and to determine if its use selects for resistant strains of ocular surface bacteria.
Methods
Conjunctival culture swabs were obtained at the pre-operative visit prior to cataract surgery and again the morning of cataract surgery in 17 patients who used topical moxifloxacin prior to surgery and in 11 control patients who did not use moxifloxacin prior to surgery. In the 17 patients who were prescribed topical moxifloxacin, they were instructed to use the medication four times daily for three days before surgery. Culture results from the study and control groups were analyzed for bacterial species growth and resistance patterns, determined by MALDI-TOF and antibiotic sensitivity analysis.
Results
In the 17 patients who used topical moxifloxacin prior to cataract surgery, 9 of 17 (52%) had persistent ocular surface bacterial growth. All control patients had persistent bacterial growth (p = 0.0097). Bacterial resistance to moxifloxacin developed in 17.6% patients using moxifloxacin; no resistance to moxifloxacin developed in the control patients (p = 0.2579). Coagulase-negative staphylococci were the most commonly cultured bacterial species in both groups. Staphylococcus epidermidis grew in 86% of positive cultures (82% in the moxifloxacin group and 91% in the controls). Other common bacterial species in both groups were corynebacterial species (32%) and Staphylococcus aureus (21%).
Conclusion
Topical moxifloxacin use prior to cataract surgery does not reduce growth of ocular surface flora effectively in most patients, and its use may select for resistant strains of bacteria which could lead to reduced efficacy of intracameral moxifloxacin at the time of surgery. A larger study is indicated to further investigate these effects.
Caroline W. Wilson, MD
Daniel C. Terveen, MD
Jaclyn M. Haugsdal, MD, ABO
Thomas A. Oetting, MD
Purpose
To investigate how the pre-operative use of topical moxifloxacin prior to cataract surgery affects the ocular surface flora, and to determine if its use selects for resistant strains of ocular surface bacteria.
Methods
Conjunctival culture swabs were obtained at the pre-operative visit prior to cataract surgery and again the morning of cataract surgery in 17 patients who used topical moxifloxacin prior to surgery and in 11 control patients who did not use moxifloxacin prior to surgery. In the 17 patients who were prescribed topical moxifloxacin, they were instructed to use the medication four times daily for three days before surgery. Culture results from the study and control groups were analyzed for bacterial species growth and resistance patterns, determined by MALDI-TOF and antibiotic sensitivity analysis.
Results
In the 17 patients who used topical moxifloxacin prior to cataract surgery, 9 of 17 (52%) had persistent ocular surface bacterial growth. All control patients had persistent bacterial growth (p = 0.0097). Bacterial resistance to moxifloxacin developed in 17.6% patients using moxifloxacin; no resistance to moxifloxacin developed in the control patients (p = 0.2579). Coagulase-negative staphylococci were the most commonly cultured bacterial species in both groups. Staphylococcus epidermidis grew in 86% of positive cultures (82% in the moxifloxacin group and 91% in the controls). Other common bacterial species in both groups were corynebacterial species (32%) and Staphylococcus aureus (21%).
Conclusion
Topical moxifloxacin use prior to cataract surgery does not reduce growth of ocular surface flora effectively in most patients, and its use may select for resistant strains of bacteria which could lead to reduced efficacy of intracameral moxifloxacin at the time of surgery. A larger study is indicated to further investigate these effects.
Retrospective Case Study Data on Dexamethasone Intraocular Suspension 9% for Inflammation Control after Cataract Surgery
Authors
Maria L. Adams, DO
Robert J. Weinstock, MD
Vasilios F. Diakonis, PhD, MD
Purpose
Following the 2019 FDA approval of Dexamethasone ntraocular suspension 9%, multicenter retrospective data is being collected in order to assess the drug’s real-world performance when used for control of inflammation following cataract surgery.
Methods
A large-scale retrospective case study has been initiated to collect real-world data on dexamethasone intraocular suspension 9%. Up to 600 patients at approximately 40 study sites will be included. Data abstracted from medical records will include the following, as available for each case: patient characteristics (age, gender, ethnicity, history of diabetes or glaucoma, risk factors for postoperative inflammation); surgical details (type of surgery, IOL and viscoelastic used, complications); concomitant medications; details of dexamethasone delivery and diffusion; clinical outcomes (anterior chamber cell/flare, visual acuity, IOP, tolerability); and surgeon and patient satisfaction.
Results
Data from 31 eyes treated with dexamethasone intraocular suspension 9% at the Eye Institute of West Florida will be presented. Among eyes with records at postoperative days 1, 8, 14, and 30, complete anterior chamber cell clearing was present in 45%, 90%, 90%, and 100%. Complete anterior chamber flare clearing was present on day 1 in 87% and in 100% for all subsequent timepoints. The product was well tolerated in all eyes at this site, with no reported adverse events, and all eyes achieved target visual acuity. Mean (SD) IOP was 17.6 (5.15), 15.3 (3.16), 17.0 (4.24), and 15.5 (3.50) mm Hg at days 1, 8, 14, and 30.
Conclusion
This subset of interim data from a larger retrospective study on dexamethasone intraocular suspension 9% reconfirms the strong, early-acting antiinflammatory efficacy and tolerability seen in phase 3 clinical studies.
Maria L. Adams, DO
Robert J. Weinstock, MD
Vasilios F. Diakonis, PhD, MD
Purpose
Following the 2019 FDA approval of Dexamethasone ntraocular suspension 9%, multicenter retrospective data is being collected in order to assess the drug’s real-world performance when used for control of inflammation following cataract surgery.
Methods
A large-scale retrospective case study has been initiated to collect real-world data on dexamethasone intraocular suspension 9%. Up to 600 patients at approximately 40 study sites will be included. Data abstracted from medical records will include the following, as available for each case: patient characteristics (age, gender, ethnicity, history of diabetes or glaucoma, risk factors for postoperative inflammation); surgical details (type of surgery, IOL and viscoelastic used, complications); concomitant medications; details of dexamethasone delivery and diffusion; clinical outcomes (anterior chamber cell/flare, visual acuity, IOP, tolerability); and surgeon and patient satisfaction.
Results
Data from 31 eyes treated with dexamethasone intraocular suspension 9% at the Eye Institute of West Florida will be presented. Among eyes with records at postoperative days 1, 8, 14, and 30, complete anterior chamber cell clearing was present in 45%, 90%, 90%, and 100%. Complete anterior chamber flare clearing was present on day 1 in 87% and in 100% for all subsequent timepoints. The product was well tolerated in all eyes at this site, with no reported adverse events, and all eyes achieved target visual acuity. Mean (SD) IOP was 17.6 (5.15), 15.3 (3.16), 17.0 (4.24), and 15.5 (3.50) mm Hg at days 1, 8, 14, and 30.
Conclusion
This subset of interim data from a larger retrospective study on dexamethasone intraocular suspension 9% reconfirms the strong, early-acting antiinflammatory efficacy and tolerability seen in phase 3 clinical studies.
Postoperative Endophthalmitis Rates Among Medicare Beneficiaries Prescribed Different Topical Antibiotics Following Cataract Surgery
Authors
Tracy W. Krick, MD
Sidra Zafar, MBBS
Peiqi Wang, MD, MPH
Divya Srikumaran, MD
Oliver Schein, MD
Fasika A. Woreta, MD, ABO
Purpose
To compare postoperative endophthalmitis rates among patients prescribed A) generic versus branded topical antibiotics, B) different classes of topical antibiotics, and C) different types of topical fluoroquinolones after cataract surgery.
Methods
This was a cross-sectional analysis of all Medicare beneficiaries with Part D coverage who underwent cataract surgery in 2016. Medicare Part D claims were used to extract information on eye drop prescriptions that were filled during the postoperative period. Rates of endophthalmitis claims within 90 days of the surgery were analyzed.
Results
The postoperative endophthalmitis rate among patients prescribed generic antibiotics was 0.07% (15/21,818) compared to 0.08% (9/10,947) among those prescribed branded antibiotics. Endophthalmitis occurred in low rates among patients prescribed all classes of antibiotics: 0% (0/53) macrolides, 0% (0/56) sulfa antibiotics, 0.09% (33/34,995) polymyxins, 0.10% (385/390,197) fluroquinolones, and 0.12% (34/27,529) aminoglycosides. Among patients prescribed different types of fluoroquinolones, the postoperative endophthalmitis rates were also similar: 0.08% (52/63,566) besifloxacin, 0.09% (80/88,944) moxifloxacin, and 0.09% (176/206,113) ofloxacin.
Conclusion
There were no clinically significant differences in postoperative endophthalmitis rates among patients prescribed different brands and types of topical antibiotics. Given considerable cost differences of medications, there is substantial opportunity for cost savings with prescription of less expensive antibiotics following cataract surgery.
Tracy W. Krick, MD
Sidra Zafar, MBBS
Peiqi Wang, MD, MPH
Divya Srikumaran, MD
Oliver Schein, MD
Fasika A. Woreta, MD, ABO
Purpose
To compare postoperative endophthalmitis rates among patients prescribed A) generic versus branded topical antibiotics, B) different classes of topical antibiotics, and C) different types of topical fluoroquinolones after cataract surgery.
Methods
This was a cross-sectional analysis of all Medicare beneficiaries with Part D coverage who underwent cataract surgery in 2016. Medicare Part D claims were used to extract information on eye drop prescriptions that were filled during the postoperative period. Rates of endophthalmitis claims within 90 days of the surgery were analyzed.
Results
The postoperative endophthalmitis rate among patients prescribed generic antibiotics was 0.07% (15/21,818) compared to 0.08% (9/10,947) among those prescribed branded antibiotics. Endophthalmitis occurred in low rates among patients prescribed all classes of antibiotics: 0% (0/53) macrolides, 0% (0/56) sulfa antibiotics, 0.09% (33/34,995) polymyxins, 0.10% (385/390,197) fluroquinolones, and 0.12% (34/27,529) aminoglycosides. Among patients prescribed different types of fluoroquinolones, the postoperative endophthalmitis rates were also similar: 0.08% (52/63,566) besifloxacin, 0.09% (80/88,944) moxifloxacin, and 0.09% (176/206,113) ofloxacin.
Conclusion
There were no clinically significant differences in postoperative endophthalmitis rates among patients prescribed different brands and types of topical antibiotics. Given considerable cost differences of medications, there is substantial opportunity for cost savings with prescription of less expensive antibiotics following cataract surgery.
Dropless Punctal Plug Dexamethasone, Intracameral Ketorolac and Moxifloxacin Compared to Conventional Topical Therapy in Cataract Surgery.
Authors
Eric D. Donnenfeld, MD
John A. Hovanesian, MD
Chad D. Hummel, MD
Jose A Quintero, MD
Purpose
To evaluate the safety and ocular efficacy of dropless Dextenza, Omidria, and intracameral moxifloxacin in controlling post-operative ocular pain, inflammation and infection associated with cataract surgery. Efficacy and compliance of dropless therapy will be compared to conventional topical medications.
Methods
This is a randomized, self-controlled prospective clinical study. Patients undergoing bilateral sequential cataract surgery will be randomized to receive two treatment groups, dropless Dextenza, Omidria, and intracameral moxifloxacin (experimental) and moxifloxacin 0.5% qid, ketorolac 0.5% qid, and prednisolone acetate 1% qid topical drops (control). Patient preference, pain, complications, and clinical outcomes will be evaluated.
Results
The experimental dropless group and the control topical medication group had no significant difference in improvement in cell and flare, postoperative pain, best corrected visual acuity, or macula thickness at 2 weeks, 1 month and 2 months. There were no cases of endophthalmitis or CME in either group. Two patients in the dropless group required rescue topical corticosteroids. 6 patients in the topical medication study developed significant superficial punctate keratitis (SPK) and no patients in the dropless group developed SPK. Patient preference was significantly higher for dropless medications than topical medications (p < 0.01).
Conclusion
Dropless Dextenza, Omidria, and intracameral moxifloxacin, are a safe and effective alternative to topical medications to reduce pain, inflammation and infection following cataract surgery. Puntal plug non-preserved corticosteroids may improve the ocular surface as compared to topical preserved corticosteroids, antibiotics and NSAIDs.
Eric D. Donnenfeld, MD
John A. Hovanesian, MD
Chad D. Hummel, MD
Jose A Quintero, MD
Purpose
To evaluate the safety and ocular efficacy of dropless Dextenza, Omidria, and intracameral moxifloxacin in controlling post-operative ocular pain, inflammation and infection associated with cataract surgery. Efficacy and compliance of dropless therapy will be compared to conventional topical medications.
Methods
This is a randomized, self-controlled prospective clinical study. Patients undergoing bilateral sequential cataract surgery will be randomized to receive two treatment groups, dropless Dextenza, Omidria, and intracameral moxifloxacin (experimental) and moxifloxacin 0.5% qid, ketorolac 0.5% qid, and prednisolone acetate 1% qid topical drops (control). Patient preference, pain, complications, and clinical outcomes will be evaluated.
Results
The experimental dropless group and the control topical medication group had no significant difference in improvement in cell and flare, postoperative pain, best corrected visual acuity, or macula thickness at 2 weeks, 1 month and 2 months. There were no cases of endophthalmitis or CME in either group. Two patients in the dropless group required rescue topical corticosteroids. 6 patients in the topical medication study developed significant superficial punctate keratitis (SPK) and no patients in the dropless group developed SPK. Patient preference was significantly higher for dropless medications than topical medications (p < 0.01).
Conclusion
Dropless Dextenza, Omidria, and intracameral moxifloxacin, are a safe and effective alternative to topical medications to reduce pain, inflammation and infection following cataract surgery. Puntal plug non-preserved corticosteroids may improve the ocular surface as compared to topical preserved corticosteroids, antibiotics and NSAIDs.
Patient and Physician Preference for an Intracanalicular Dexamethasone Insert for Treating Inflammation and Pain Following Cataract Surgery
Authors
Cathleen M. McCabe, MD
John P. Berdahl, MD
Sydney Tyson, MD, MPH
Inder P. Singh, MD
Srilatha Vantipalli, PhD
Jamie Lynne Metzinger, MSc, MPH
Michael H. Goldstein, MD, MBA
Purpose
Standard of care post-ocular surgery includes corticosteroid eyedrops, a burden for patients. DEXTENZA® (dexamethasone ophthalmic insert), a resorbable intracanalicular insert delivering a tapering dose over 30 days, is intended to eliminate this burden. Here we evaluate physician and patient reported outcomes regarding DEXTENZA insertion.
Methods
Three prospective, double-masked, parallel-arm, vehicle-controlled Phase 3 studies were conducted. Adult subjects (n=923; >18 years) who had undergone cataract surgery with intraocular implantation on Day 1 were randomized to receive either DEXTENZA (DEX; n=538) or Placebo (PV; n=385), immediately following surgery. Post-hoc pooled analyses of the three trials was conducted to capture the physician experience by evaluating ease of product use and ease of subsequent visualization in the clinical setting. Additionally, in one trial, patient experience with DEXTENZA was captured on a 5-point Likert scale (1=worst; 5=best) via written (N=216) or phone (N=25) end-of-study questionnaires.
Results
Investigators rated the product as easy or moderately easy to insert in 97.7% of DEXTENZA eyes. DEXTENZA was visualized in 99.5% of subjects at Day 14; inserts were rated as easy or moderately easy to visualize in >95% of eyes. DEXTENZA subjects reported high scores (scores of 3 and above) with respect to relief of eye pain and discomfort, comfort (96%), convenience (97%) and overall satisfaction (93%) and was significantly better compared to placebo (p < 0.01). Subjects thought the insert helped compliance (93%), they would be likely to ask for the insert again (93%), and likely to recommend it to others (95%).
Conclusion
DEXTENZA was rated positively by physicians and patients. From the physician’s perspective, DEXTENZA was easy to insert and visualize throughout postop period. From the patient perspective, DEXTENZA helped with compliance and were likely to request again. Monitoring insert presence overtime ensures continuous drug delivery compared to via drops.
Cathleen M. McCabe, MD
John P. Berdahl, MD
Sydney Tyson, MD, MPH
Inder P. Singh, MD
Srilatha Vantipalli, PhD
Jamie Lynne Metzinger, MSc, MPH
Michael H. Goldstein, MD, MBA
Purpose
Standard of care post-ocular surgery includes corticosteroid eyedrops, a burden for patients. DEXTENZA® (dexamethasone ophthalmic insert), a resorbable intracanalicular insert delivering a tapering dose over 30 days, is intended to eliminate this burden. Here we evaluate physician and patient reported outcomes regarding DEXTENZA insertion.
Methods
Three prospective, double-masked, parallel-arm, vehicle-controlled Phase 3 studies were conducted. Adult subjects (n=923; >18 years) who had undergone cataract surgery with intraocular implantation on Day 1 were randomized to receive either DEXTENZA (DEX; n=538) or Placebo (PV; n=385), immediately following surgery. Post-hoc pooled analyses of the three trials was conducted to capture the physician experience by evaluating ease of product use and ease of subsequent visualization in the clinical setting. Additionally, in one trial, patient experience with DEXTENZA was captured on a 5-point Likert scale (1=worst; 5=best) via written (N=216) or phone (N=25) end-of-study questionnaires.
Results
Investigators rated the product as easy or moderately easy to insert in 97.7% of DEXTENZA eyes. DEXTENZA was visualized in 99.5% of subjects at Day 14; inserts were rated as easy or moderately easy to visualize in >95% of eyes. DEXTENZA subjects reported high scores (scores of 3 and above) with respect to relief of eye pain and discomfort, comfort (96%), convenience (97%) and overall satisfaction (93%) and was significantly better compared to placebo (p < 0.01). Subjects thought the insert helped compliance (93%), they would be likely to ask for the insert again (93%), and likely to recommend it to others (95%).
Conclusion
DEXTENZA was rated positively by physicians and patients. From the physician’s perspective, DEXTENZA was easy to insert and visualize throughout postop period. From the patient perspective, DEXTENZA helped with compliance and were likely to request again. Monitoring insert presence overtime ensures continuous drug delivery compared to via drops.
Vision Outcomes Following Cataract Surgery with an Intracanalicular Dexamethasone Insert for Treating Postoperative Inflammation and Pain
Authors
Steven M. Silverstein, MD, FACS, ABO
John A. Hovanesian, MD
Shamik Bafna, MD
Alice T. Epitropoulos, MD, FACS, ABO
Srilatha Vantipalli, PhD
Jamie Lynne Metzinger, MSc, MPH
Michael H. Goldstein, MD, MBA
Purpose
Intracanalicular dexamethasone insert is a resorbable sustained-release insert delivering a 0.4 mg tapered dose of dexamethasone for up to 30 days, designed to obviate the need for corticosteroid drops. Here we characterize the visual outcomes following cataract surgery in clinical development program for the intracanalicular dexamethasone insert.
Methods
Four prospective, double-masked, parallel-arm, vehicle-controlled clinical trials were conducted (one Phase 2 and three Phase 3). Adult subjects (n = 982; >18 years) who had undergone cataract surgery with intraocular implantation on Day 1 were randomized to receive either a dexamethasone intracanalicular insert (DEX; n = 567) or placebo (PV; n = 415), immediately following surgery. Proportion of subjects in both groups attaining 20/20 vision or better (snellen pinhole corrected vision) from post-operative Days 2, 4, 8, 14 and 30 were captured in the four trials. Post-hoc pooled analyses of the four trials was conducted to evaluate the vision outcomes following cataract surgery.
Results
A significantly (p < 0.05) greater proportion of DEX treated subjects (36%) attained 20/20 vision or better as early as Day 4, compared to placebo group (29.2%). Consistently greater proportions (p < 0.05) of DEX treated subjects reached 20/20 vision or better on Day 8 (DEX: PV 42%:32%) and Day 14 (DEX: PV 45%:37%) compared to Placebo treated subjects. By Day 30, there was no statistically significant difference (p > 0.05) in the proportion of subjects reaching 20/20 or better between the groups (DEX: PV 49%:47%). Similar results were observed even after excluding the subjects who received rescue medications in both groups during the trial.
Conclusion
Visual outcomes with DEX following cataract surgery are better as early as Day 4 (post-op day 3) than placebo treated subjects and continued to be better until Day 14. 36% of DEX treated subjects reached 20/20 vision or better by Day 4, while it took the same percentage of placebo treated subjects longer (by Day 14) to reach 20/20 vision.
Steven M. Silverstein, MD, FACS, ABO
John A. Hovanesian, MD
Shamik Bafna, MD
Alice T. Epitropoulos, MD, FACS, ABO
Srilatha Vantipalli, PhD
Jamie Lynne Metzinger, MSc, MPH
Michael H. Goldstein, MD, MBA
Purpose
Intracanalicular dexamethasone insert is a resorbable sustained-release insert delivering a 0.4 mg tapered dose of dexamethasone for up to 30 days, designed to obviate the need for corticosteroid drops. Here we characterize the visual outcomes following cataract surgery in clinical development program for the intracanalicular dexamethasone insert.
Methods
Four prospective, double-masked, parallel-arm, vehicle-controlled clinical trials were conducted (one Phase 2 and three Phase 3). Adult subjects (n = 982; >18 years) who had undergone cataract surgery with intraocular implantation on Day 1 were randomized to receive either a dexamethasone intracanalicular insert (DEX; n = 567) or placebo (PV; n = 415), immediately following surgery. Proportion of subjects in both groups attaining 20/20 vision or better (snellen pinhole corrected vision) from post-operative Days 2, 4, 8, 14 and 30 were captured in the four trials. Post-hoc pooled analyses of the four trials was conducted to evaluate the vision outcomes following cataract surgery.
Results
A significantly (p < 0.05) greater proportion of DEX treated subjects (36%) attained 20/20 vision or better as early as Day 4, compared to placebo group (29.2%). Consistently greater proportions (p < 0.05) of DEX treated subjects reached 20/20 vision or better on Day 8 (DEX: PV 42%:32%) and Day 14 (DEX: PV 45%:37%) compared to Placebo treated subjects. By Day 30, there was no statistically significant difference (p > 0.05) in the proportion of subjects reaching 20/20 or better between the groups (DEX: PV 49%:47%). Similar results were observed even after excluding the subjects who received rescue medications in both groups during the trial.
Conclusion
Visual outcomes with DEX following cataract surgery are better as early as Day 4 (post-op day 3) than placebo treated subjects and continued to be better until Day 14. 36% of DEX treated subjects reached 20/20 vision or better by Day 4, while it took the same percentage of placebo treated subjects longer (by Day 14) to reach 20/20 vision.
Resolution of Inflammation and Pain Following Cataract Surgery with an Intracanalicular Dexamethasone Insert
Authors
Sumitra S. Khandelwal, MD, ABO
Jeffrey H. Levenson, MD
Joseph P. Gira, MD
Srilatha Vantipalli, PhD
Jamie Lynne Metzinger, MSc, MPH
Michael H. Goldstein, MD, MBA
Purpose
DEXTENZA® (dexamethasone ophthalmic insert) is a resorbable intracanalicular insert delivering a tapered dose of 0.4 mg dexamethasone for up to 30 days, designed to obviate the need for corticosteroid drops. Here we evaluate the efficacy of DEXTENZA in resolving inflammation and pain following cataract surgery in three Phase 3 trials.
Methods
Three prospective, double-masked, parallel-arm, vehicle-controlled Phase 3 studies were conducted. Subjects (n=926) who had undergone cataract surgery with intraocular implantation on Day 1 were randomized to receive either DEXTENZA (DEX; n=541) or Placebo (PV; n=385), immediately following surgery; follow-up visits occurred at Days 2, 4, 8, 14, 30 and 45/60. Absence of anterior chamber cell (score of 0) and absence of pain were captured at every visit. Post-hoc pooled analysis was conducted to evaluate the time to resolution of post-surgical inflammation and pain. Resolution was defined as the first occurrence of clinically meaningful scores of 0 or 0.5+ during the postoperative period.
Results
Median time to resolution of anterior chamber cells (Score of 0, 0.5+) in DEXTENZA treated subjects was 7 days (25th – 75th percentile: 4 – 15 days) and in placebo treated subjects was 14 days ((25th – 75th percentile: 4 – 31 days). Median time to resolution of pain (Score of 0. 0.5+) in DEXTENZA treated subjects was 2 days (25th – 75th percentile: 2 – 4 days) and in Placebo treated subjects was 2 days ((25th – 75th percentile: 2 – 14 days). Log-Rank test showed statistically significant lesser (p < 0.0001) time to resolution curves in subjects treated with DEXTENZA as compared to Placebo for both inflammation and pain.
Conclusion
Time to clinically meaningful resolution of post-cataract inflammation was faster with DEXTENZA than placebo. 75th percentile population had faster resolution of pain by 4 days with DEXTENZA than placebo (14 days). DEXTENZA provides rapid efficacy in resolving post-surgical pain and inflammation compared to placebo during the postoperative period.
Sumitra S. Khandelwal, MD, ABO
Jeffrey H. Levenson, MD
Joseph P. Gira, MD
Srilatha Vantipalli, PhD
Jamie Lynne Metzinger, MSc, MPH
Michael H. Goldstein, MD, MBA
Purpose
DEXTENZA® (dexamethasone ophthalmic insert) is a resorbable intracanalicular insert delivering a tapered dose of 0.4 mg dexamethasone for up to 30 days, designed to obviate the need for corticosteroid drops. Here we evaluate the efficacy of DEXTENZA in resolving inflammation and pain following cataract surgery in three Phase 3 trials.
Methods
Three prospective, double-masked, parallel-arm, vehicle-controlled Phase 3 studies were conducted. Subjects (n=926) who had undergone cataract surgery with intraocular implantation on Day 1 were randomized to receive either DEXTENZA (DEX; n=541) or Placebo (PV; n=385), immediately following surgery; follow-up visits occurred at Days 2, 4, 8, 14, 30 and 45/60. Absence of anterior chamber cell (score of 0) and absence of pain were captured at every visit. Post-hoc pooled analysis was conducted to evaluate the time to resolution of post-surgical inflammation and pain. Resolution was defined as the first occurrence of clinically meaningful scores of 0 or 0.5+ during the postoperative period.
Results
Median time to resolution of anterior chamber cells (Score of 0, 0.5+) in DEXTENZA treated subjects was 7 days (25th – 75th percentile: 4 – 15 days) and in placebo treated subjects was 14 days ((25th – 75th percentile: 4 – 31 days). Median time to resolution of pain (Score of 0. 0.5+) in DEXTENZA treated subjects was 2 days (25th – 75th percentile: 2 – 4 days) and in Placebo treated subjects was 2 days ((25th – 75th percentile: 2 – 14 days). Log-Rank test showed statistically significant lesser (p < 0.0001) time to resolution curves in subjects treated with DEXTENZA as compared to Placebo for both inflammation and pain.
Conclusion
Time to clinically meaningful resolution of post-cataract inflammation was faster with DEXTENZA than placebo. 75th percentile population had faster resolution of pain by 4 days with DEXTENZA than placebo (14 days). DEXTENZA provides rapid efficacy in resolving post-surgical pain and inflammation compared to placebo during the postoperative period.
Assessment of the Cumulative Dextenza Drug Effect Compared to Placebo in the Pooled Phase 3 Studies Via Area Under the Curve (AUC) Analysis
Authors
Francis S. Mah, MD
Matthew T. Feng, MD
Michael B. Raizman, MD
Bruce Silverstein, MD
Srilatha Vantipalli, PhD
Jamie Lynne Metzinger, MSc, MPH
Michael H. Goldstein, MD, MBA
Andrea A. Gibson, PhD
Purpose
DEXTENZA®(dexamethasone ophthalmic insert) is a resorbable sustained-release intracanalicular insert delivering a 0.4 mg dose of dexamethasone over 30 days, designed to obviate the need for corticosteroid drops. Herein, a cumulative measure of drug effect, area under the curve (AUC) analysis was undertaken with DEXTENZA following cataract surgery.
Methods
Three prospective, double-masked, parallel-arm, vehicle-controlled Phase 3 studies were conducted. Adult subjects (n=926; >18 years) who had undergone cataract surgery with intraocular implantation on Day 1 were randomized to receive either DEXTENZA (DEX; n=541) or Placebo (PV; n=385), immediately following surgery; follow-up visits were at Days 2, 4, 8, 14, 30 and 45/60. Anterior chamber cell counts, flare and pain scores were captured at every visit. In the pooled phase 3 studies, post-hoc AUC analysis was performed to assess the cumulative effect on anterior chamber cell counts, anterior chamber cell flare scores, and pain scores with DEXTENZA compared to placebo.
Results
Compared to patients treated with placebo (PV; n=375), the mean difference in anterior chamber cell count AUC outcomes in patients treated with DEXTENZA (DEX; n=528) was -15.28% (95% CI, -20.46, -10.10, p < .0001). Compared to patients treated with placebo (PV; n=376), the mean difference in anterior chamber cell flare score AUC outcomes in patients treated with DEXTENZA (DEX; n=528) was -13.73% (95% CI, -17.86, -9.60, p < .0001). Compared to placebo (PV; n=376), the mean difference in pain score AUC outcomes in patients treated with DEXTENZA (DEX; n=527) was -23.26% (95% CI, -32.31, -14.22, p < .0001).
Conclusion
AUC outcomes demonstrated herein suggest consistency of cumulative drug effect benefits with DEXTENZA compared to PV in phase 3 trials. Because DEXTENZA may obviate the need for corticosteroid drops following ophthalmic surgery, these data further support the totality of available DEXTENZA efficacy evidence for post-cataract inflammation and pain.
Francis S. Mah, MD
Matthew T. Feng, MD
Michael B. Raizman, MD
Bruce Silverstein, MD
Srilatha Vantipalli, PhD
Jamie Lynne Metzinger, MSc, MPH
Michael H. Goldstein, MD, MBA
Andrea A. Gibson, PhD
Purpose
DEXTENZA®(dexamethasone ophthalmic insert) is a resorbable sustained-release intracanalicular insert delivering a 0.4 mg dose of dexamethasone over 30 days, designed to obviate the need for corticosteroid drops. Herein, a cumulative measure of drug effect, area under the curve (AUC) analysis was undertaken with DEXTENZA following cataract surgery.
Methods
Three prospective, double-masked, parallel-arm, vehicle-controlled Phase 3 studies were conducted. Adult subjects (n=926; >18 years) who had undergone cataract surgery with intraocular implantation on Day 1 were randomized to receive either DEXTENZA (DEX; n=541) or Placebo (PV; n=385), immediately following surgery; follow-up visits were at Days 2, 4, 8, 14, 30 and 45/60. Anterior chamber cell counts, flare and pain scores were captured at every visit. In the pooled phase 3 studies, post-hoc AUC analysis was performed to assess the cumulative effect on anterior chamber cell counts, anterior chamber cell flare scores, and pain scores with DEXTENZA compared to placebo.
Results
Compared to patients treated with placebo (PV; n=375), the mean difference in anterior chamber cell count AUC outcomes in patients treated with DEXTENZA (DEX; n=528) was -15.28% (95% CI, -20.46, -10.10, p < .0001). Compared to patients treated with placebo (PV; n=376), the mean difference in anterior chamber cell flare score AUC outcomes in patients treated with DEXTENZA (DEX; n=528) was -13.73% (95% CI, -17.86, -9.60, p < .0001). Compared to placebo (PV; n=376), the mean difference in pain score AUC outcomes in patients treated with DEXTENZA (DEX; n=527) was -23.26% (95% CI, -32.31, -14.22, p < .0001).
Conclusion
AUC outcomes demonstrated herein suggest consistency of cumulative drug effect benefits with DEXTENZA compared to PV in phase 3 trials. Because DEXTENZA may obviate the need for corticosteroid drops following ophthalmic surgery, these data further support the totality of available DEXTENZA efficacy evidence for post-cataract inflammation and pain.
Models of Intracameral Antibiotic Concentration Decay Explain the Efficacy of Supplementary Topical and/or Oral Antibiotic Administration.
Authors
Steve A. Arshinoff, MD, FRCSC
Albert Hu, BEng
Mark K. Lukewich, PhD
Milad Modabber, MD, FRCSC, MSc
Purpose
To better understand why studies of topical and oral supplemental administration of antibiotics have not conclusively shown efficacy in preventing post-operative endophthalmitis, and when they may be effective
Methods
Mathematical models of intracameral antibiotic concentration decay in the anterior chamber compared to resistance levels were created to better understand the duration of antibacterial efficacy of intracameral administration of prophylactic antibiotics. The additional anterior chamber concentration effects of topical and oral supplementation were determined and plotted.
Results
Graphs of antibiotic concentration decay were drawn illustrating what happens under various assumptions. The results are consistent with experimental data from the literature.
Conclusion
The study of models of intracameral antibiotic concentration decay can enhance our understanding of the effects of our current protocols and suggest better practices.
Steve A. Arshinoff, MD, FRCSC
Albert Hu, BEng
Mark K. Lukewich, PhD
Milad Modabber, MD, FRCSC, MSc
Purpose
To better understand why studies of topical and oral supplemental administration of antibiotics have not conclusively shown efficacy in preventing post-operative endophthalmitis, and when they may be effective
Methods
Mathematical models of intracameral antibiotic concentration decay in the anterior chamber compared to resistance levels were created to better understand the duration of antibacterial efficacy of intracameral administration of prophylactic antibiotics. The additional anterior chamber concentration effects of topical and oral supplementation were determined and plotted.
Results
Graphs of antibiotic concentration decay were drawn illustrating what happens under various assumptions. The results are consistent with experimental data from the literature.
Conclusion
The study of models of intracameral antibiotic concentration decay can enhance our understanding of the effects of our current protocols and suggest better practices.
Effect of Intracameral Phenylephrine 1.0%/Ketorolac 0.3% on Cystoid Macular Edema, Breakthrough Iritis, and Pain Following Cataract Surgery
Author
Denise M. Visco, MD, MBA, ABO
Purpose
To evaluate the effectiveness of intracameral phenylephrine and ketorolac 1.0%/0.3% during cataract surgery compared to postoperative steroids in reducing the risk of postoperative cystoid macular edema (CME), breakthrough iritis, photophobia, and pain.
Methods
Single-site, 2-cohort, retrospective study of cataract surgery patients to assess postoperative CME, breakthrough iritis, photophobia, and pain. Patients received either intracameral phenylephrine and ketorolac 1.0%/0.3% (n=1334) during surgery or topical loteprednol 0.5% (n=884) given 2 days preoperatively and tapered postoperatively. Patients with prior CME, combined cataract/glaucoma surgery, and medication protocols different from those examined in this study were excluded, as were eyes at high risk for postoperative CME from retinal vein occlusion, vitreomacular traction, macular pucker, and epiretinal membrane. All patients received bromfenac 2 days pre- and 10 weeks postoperatively.
Results
The study enrolled 2218 eyes of 1402 patients (831 females, 571 males). The phenylephrine/ketorolac study group included 1334 eyes of 830 patients (mean 69.2 ± 9.4 years) and loteprednol control group included 884 eyes of 572 patients (mean 67.6 ± 9.1 years). The groups were comparable in terms of race, gender, and most perioperative characteristics. CME incidence was significantly lower in the study group (0.5% vs 1.47%, P=0.021). The study group also had significantly lower incidence of breakthrough iritis (1.7% vs 4.9%, P<0.001) and pain (1.3% vs 4.19%, P<0.001) compared with the control group. The incidence of photophobia was comparable (0.9% vs 1.13%, P=0.590) between the two groups.
Conclusion
Intracameral phenylephrine/ketorolac and topical NSAIDS (without postoperative steroids) significantly reduced postoperative CME, breakthrough iritis, and pain after cataract surgery compared with conventional perioperative treatment using topical steroids and NSAIDS. This could decrease reliance on compliance-dependent topical drop regimens.
Denise M. Visco, MD, MBA, ABO
Purpose
To evaluate the effectiveness of intracameral phenylephrine and ketorolac 1.0%/0.3% during cataract surgery compared to postoperative steroids in reducing the risk of postoperative cystoid macular edema (CME), breakthrough iritis, photophobia, and pain.
Methods
Single-site, 2-cohort, retrospective study of cataract surgery patients to assess postoperative CME, breakthrough iritis, photophobia, and pain. Patients received either intracameral phenylephrine and ketorolac 1.0%/0.3% (n=1334) during surgery or topical loteprednol 0.5% (n=884) given 2 days preoperatively and tapered postoperatively. Patients with prior CME, combined cataract/glaucoma surgery, and medication protocols different from those examined in this study were excluded, as were eyes at high risk for postoperative CME from retinal vein occlusion, vitreomacular traction, macular pucker, and epiretinal membrane. All patients received bromfenac 2 days pre- and 10 weeks postoperatively.
Results
The study enrolled 2218 eyes of 1402 patients (831 females, 571 males). The phenylephrine/ketorolac study group included 1334 eyes of 830 patients (mean 69.2 ± 9.4 years) and loteprednol control group included 884 eyes of 572 patients (mean 67.6 ± 9.1 years). The groups were comparable in terms of race, gender, and most perioperative characteristics. CME incidence was significantly lower in the study group (0.5% vs 1.47%, P=0.021). The study group also had significantly lower incidence of breakthrough iritis (1.7% vs 4.9%, P<0.001) and pain (1.3% vs 4.19%, P<0.001) compared with the control group. The incidence of photophobia was comparable (0.9% vs 1.13%, P=0.590) between the two groups.
Conclusion
Intracameral phenylephrine/ketorolac and topical NSAIDS (without postoperative steroids) significantly reduced postoperative CME, breakthrough iritis, and pain after cataract surgery compared with conventional perioperative treatment using topical steroids and NSAIDS. This could decrease reliance on compliance-dependent topical drop regimens.
Intra-Operative Medications Used during Cataract Surgery to Safely Substitute the Need for a Patient Having Surgery to Purchase Medication.
Authors
Scott E. LaBorwit, MD
Robert S. Stutman, OD, MBA
Methods
Retrospective review of patients who had cataract surgery over a 4-year period. Patients determined during initial consultation to need drops post-operative were not included. Included patients received intra-cameral moxifloxacin and sub-tenons Kenalog at the time of cataract surgery along with peri-operative antibiotic drops and Betadine 5%. Significant risk post operatively would include patients with endophthalmitis, allergic reaction to medication, persistent elevation of eye pressure and any other long-term vision-threatening outcome related to inflammation or infection.
Results
Between 2015 and 2019 there were 6,150 cataract surgeries performed. There were no intra-operative complications related to placement of medication. There were no cases of endophthalmitis. There was a peripheral corneal ulcer in a 2 patients(0.033%) each at 2 weeks post operatively. As a result of elevated IOP after 3 months on medication, 10 patients(0.16%) required needling of the sub-tenons Kenalog (STK) in the office and 2 patients(0.0033%) had complete excision of the STK. This treatment resulted in normalization of IOP off all medication and no glaucoma damage. There were no other significant long-term vision-threatening outcomes related to inflammation or infection.
Conclusion
Elimination of post-operative drops for cataract surgery by utilizing intra-operative medication at the time of surgery is a safe alternative with minimal risk. Ophthalmologists may consider this cost-effective alternative by implementing a similar strategy to decrease unnecessary healthcare costs, patient compliance and side effects of drops.
Scott E. LaBorwit, MD
Robert S. Stutman, OD, MBA
Methods
Retrospective review of patients who had cataract surgery over a 4-year period. Patients determined during initial consultation to need drops post-operative were not included. Included patients received intra-cameral moxifloxacin and sub-tenons Kenalog at the time of cataract surgery along with peri-operative antibiotic drops and Betadine 5%. Significant risk post operatively would include patients with endophthalmitis, allergic reaction to medication, persistent elevation of eye pressure and any other long-term vision-threatening outcome related to inflammation or infection.
Results
Between 2015 and 2019 there were 6,150 cataract surgeries performed. There were no intra-operative complications related to placement of medication. There were no cases of endophthalmitis. There was a peripheral corneal ulcer in a 2 patients(0.033%) each at 2 weeks post operatively. As a result of elevated IOP after 3 months on medication, 10 patients(0.16%) required needling of the sub-tenons Kenalog (STK) in the office and 2 patients(0.0033%) had complete excision of the STK. This treatment resulted in normalization of IOP off all medication and no glaucoma damage. There were no other significant long-term vision-threatening outcomes related to inflammation or infection.
Conclusion
Elimination of post-operative drops for cataract surgery by utilizing intra-operative medication at the time of surgery is a safe alternative with minimal risk. Ophthalmologists may consider this cost-effective alternative by implementing a similar strategy to decrease unnecessary healthcare costs, patient compliance and side effects of drops.
Prevalence of Preoperative Dry Eye Diagnosis and Treatment Among Cataract Surgery Patients: An AAO IRIS® Registry Analysis
Authors
Christopher E. Starr, MD
Thao N. Yeh, OD, PhD, MPH
Mohinder Merchea, OD, PhD
Purpose
To determine the prevalence of dry eye disease (DED) diagnosis and proportion of patients receiving DED treatment prior to surgery among 89,947 patients who had intraocular lens (IOL) implantation with cataract surgery. Also, differences in DED treatment rates based on receiving an advanced technology IOL (ATIOL) or monofocal IOL were investigated.
Methods
Non-interventional, retrospective database analysis of the IRIS® Registry. ICD-10 and CPT codes were used to identify patients who had a cataract diagnosis and surgery with an IOL implant from January 1, 2016 to March 31, 2018. For patients identified with DED, including meibomian gland dysfunction (MGD) using ICD-9/10 codes, the CPT treatment codes (eyelid heat therapy, punctal procedures, and amniotic membrane) or medications (cyclosporine, lifitegrast) were noted within the 12 weeks preceding surgery. Co-primary outcomes were prevalence of DED and proportion of patients treated before surgery. Secondary outcome was the odds of receiving DED treatment given IOL implant type.
Results
26,543 patients (29.5%) from the cataract surgery cohort were diagnosed with DED, including MGD. Among patients diagnosed with DED, only 3.0% (808 patients) were treated within 12 weeks of surgery. Of the patients who received DED treatment, 66.1% (534 patients) received an ATIOL implant. Patients had 2.1 greater odds of receiving DED treatment when given an ATIOL (95% Confidence Interval: 1.8, 2.4), after controlling for age, sex, race, and geographical region.
Conclusion
Although signs and symptoms are reported as high as 80% in some studies, DED was diagnosed in 29.5% of cataract patients in this study. Only 3% of diagnosed patients were treated with prescription medications or procedures, and those receiving an ATIOL were significantly more likely to be treated.
Christopher E. Starr, MD
Thao N. Yeh, OD, PhD, MPH
Mohinder Merchea, OD, PhD
Purpose
To determine the prevalence of dry eye disease (DED) diagnosis and proportion of patients receiving DED treatment prior to surgery among 89,947 patients who had intraocular lens (IOL) implantation with cataract surgery. Also, differences in DED treatment rates based on receiving an advanced technology IOL (ATIOL) or monofocal IOL were investigated.
Methods
Non-interventional, retrospective database analysis of the IRIS® Registry. ICD-10 and CPT codes were used to identify patients who had a cataract diagnosis and surgery with an IOL implant from January 1, 2016 to March 31, 2018. For patients identified with DED, including meibomian gland dysfunction (MGD) using ICD-9/10 codes, the CPT treatment codes (eyelid heat therapy, punctal procedures, and amniotic membrane) or medications (cyclosporine, lifitegrast) were noted within the 12 weeks preceding surgery. Co-primary outcomes were prevalence of DED and proportion of patients treated before surgery. Secondary outcome was the odds of receiving DED treatment given IOL implant type.
Results
26,543 patients (29.5%) from the cataract surgery cohort were diagnosed with DED, including MGD. Among patients diagnosed with DED, only 3.0% (808 patients) were treated within 12 weeks of surgery. Of the patients who received DED treatment, 66.1% (534 patients) received an ATIOL implant. Patients had 2.1 greater odds of receiving DED treatment when given an ATIOL (95% Confidence Interval: 1.8, 2.4), after controlling for age, sex, race, and geographical region.
Conclusion
Although signs and symptoms are reported as high as 80% in some studies, DED was diagnosed in 29.5% of cataract patients in this study. Only 3% of diagnosed patients were treated with prescription medications or procedures, and those receiving an ATIOL were significantly more likely to be treated.
Postoperative Cystoid Macular Rates and Costs Associated with Brand Versus Generic Medications Among Patients Undergoing Cataract Surgery
Authors
Sidra Zafar, MBBS
Peiqi Wang, MD, MPH
Oliver Schein, MD
Divya Srikumaran, MD
Fasika A. Woreta, MD, ABO
Purpose
To compare postoperative cystoid macular edema (CME) rates between A) brand vs. generic NSAIDs, and, B) brand vs. generic steroids and cost-savings associated with cheaper alternatives
Methods
This a retrospective analysis of the 2016 Medicare carrier files and Medicare Part D claims. Our study population included all patients who underwent cataract surgery in 2016. The primary outcome was the CME rate among these patients within 90 days of their cataract surgery. We ran multiple logistic regressions adjusted for race and high-risk ocular comorbidities (epiretinal membrane, central/branch retinal vein occlusion, diabetic retinopathy and macular hole) to assess the risk of developing CME with different treatment regimes. We also assessed cost-savings associated with cheaper alternatives
Results
The overall rate of CME among 591,733 patients who underwent cataract surgery in 2016 was 0.58%. Postoperative CME rates between patients prescribed A) brand vs. generic NSAIDs were 0.47% vs. 0.67% (odds ratio [OR]= 0.69, 95% confidence interval [CI]: 0.52-0.91) and, B) brand vs. generic steroids were 0.60% vs. 0.68% (OR=0.87, 95% CI: 0.76-1.00). The approximate costs associated with brand NSAIDs and steroids were $54 million and $36 million, respectively. If lower cost therapeutic substitutions are used, cost savings would be reduced by $47 million for NSAIDs and $23 million for steroids
Conclusion
Postoperative CME rates among Medicare beneficiaries undergoing cataract surgery in 2016 were low and comparable between brand vs. generic treatment regimes. Given considerable cost differences of medications, there is substantial opportunity for cost savings with prescription of less expensive anti-inflammatory agents following cataract surgery
Sidra Zafar, MBBS
Peiqi Wang, MD, MPH
Oliver Schein, MD
Divya Srikumaran, MD
Fasika A. Woreta, MD, ABO
Purpose
To compare postoperative cystoid macular edema (CME) rates between A) brand vs. generic NSAIDs, and, B) brand vs. generic steroids and cost-savings associated with cheaper alternatives
Methods
This a retrospective analysis of the 2016 Medicare carrier files and Medicare Part D claims. Our study population included all patients who underwent cataract surgery in 2016. The primary outcome was the CME rate among these patients within 90 days of their cataract surgery. We ran multiple logistic regressions adjusted for race and high-risk ocular comorbidities (epiretinal membrane, central/branch retinal vein occlusion, diabetic retinopathy and macular hole) to assess the risk of developing CME with different treatment regimes. We also assessed cost-savings associated with cheaper alternatives
Results
The overall rate of CME among 591,733 patients who underwent cataract surgery in 2016 was 0.58%. Postoperative CME rates between patients prescribed A) brand vs. generic NSAIDs were 0.47% vs. 0.67% (odds ratio [OR]= 0.69, 95% confidence interval [CI]: 0.52-0.91) and, B) brand vs. generic steroids were 0.60% vs. 0.68% (OR=0.87, 95% CI: 0.76-1.00). The approximate costs associated with brand NSAIDs and steroids were $54 million and $36 million, respectively. If lower cost therapeutic substitutions are used, cost savings would be reduced by $47 million for NSAIDs and $23 million for steroids
Conclusion
Postoperative CME rates among Medicare beneficiaries undergoing cataract surgery in 2016 were low and comparable between brand vs. generic treatment regimes. Given considerable cost differences of medications, there is substantial opportunity for cost savings with prescription of less expensive anti-inflammatory agents following cataract surgery
Phase 3 Trial Evaluating an Intracanalicular Dexamethasone Insert (0.4 mg) for the Treatment of Patients with Allergic Conjunctivitis
Authors
Kenneth R. Kenyon, MD
Eugene B. McLaurin, MD
Steven M. Silverstein, MD, FACS, ABO
John C. Meyer, MD
Erik Anderson, MD
Ravi R. Patel, MD
Michael H. Goldstein, MD, MBA
Purpose
To evaluate the safety and efficacy of DEXTENZA (DEX), a resorbable, sustained-release intracanalicular insert delivering a 0.4 mg hands-free, tapered dose of dexamethasone over 30 days for the treatment of allergic conjunctivitis using a modified Conjunctival Allergen Challenge (CAC) Model.
Methods
A multi-center, randomized, prospective, double-masked, vehicle-controlled Phase 3 study was conducted using multiple CAC challenges. DEX or placebo vehicle (PV) was inserted bilaterally on Day 1 in subjects (N=96) after confirmation of positive allergic reaction. Ocular itching was evaluated at 3, 5, and 7 mins post-CAC at Day 8 (8 hours post Visit 6a, 7 days post-insertion) as the primary study endpoint. Other secondary efficacy measures include ocular itching (other time points), other ocular and non-ocular symptoms post-CAC at Days 7, 8, 14, 15. Safety assessments included adverse event (AE) collection, visual acuity, slit lamp, punctum exam, intraocular pressure and fundoscopy.
Results
For the primary endpoint, DEX was statistically significantly superior for lowering mean ocular itch scores compared with PV at all time points (P<0.0001). Difference in ocular itching scores favored DEX over PV: 0.86 units at 3 min, 0.98 units at 5 min and 0.96 units at 7 min. For secondary endpoints at all other visits, subjects treated with DEX did better than PV for ocular itching scores post-CAC for all time points (P<0.05 at all visits except Visit 5, 3 minutes). These data are consistent with prior Phase 2 and Phase 3A studies. There were no serious AEs (ocular or non-ocular) and no subjects required rescue. There were no subjects with elevated IOP.
Conclusion
The primary endpoint of the trial was successfully met; DEXTENZA provided a sustained reduction in ocular itching, demonstrating promise as a potential hands-free steroid alternative for patients with allergic conjunctivitis. DEXTENZA was generally safe and well-tolerated in this study.
Kenneth R. Kenyon, MD
Eugene B. McLaurin, MD
Steven M. Silverstein, MD, FACS, ABO
John C. Meyer, MD
Erik Anderson, MD
Ravi R. Patel, MD
Michael H. Goldstein, MD, MBA
Purpose
To evaluate the safety and efficacy of DEXTENZA (DEX), a resorbable, sustained-release intracanalicular insert delivering a 0.4 mg hands-free, tapered dose of dexamethasone over 30 days for the treatment of allergic conjunctivitis using a modified Conjunctival Allergen Challenge (CAC) Model.
Methods
A multi-center, randomized, prospective, double-masked, vehicle-controlled Phase 3 study was conducted using multiple CAC challenges. DEX or placebo vehicle (PV) was inserted bilaterally on Day 1 in subjects (N=96) after confirmation of positive allergic reaction. Ocular itching was evaluated at 3, 5, and 7 mins post-CAC at Day 8 (8 hours post Visit 6a, 7 days post-insertion) as the primary study endpoint. Other secondary efficacy measures include ocular itching (other time points), other ocular and non-ocular symptoms post-CAC at Days 7, 8, 14, 15. Safety assessments included adverse event (AE) collection, visual acuity, slit lamp, punctum exam, intraocular pressure and fundoscopy.
Results
For the primary endpoint, DEX was statistically significantly superior for lowering mean ocular itch scores compared with PV at all time points (P<0.0001). Difference in ocular itching scores favored DEX over PV: 0.86 units at 3 min, 0.98 units at 5 min and 0.96 units at 7 min. For secondary endpoints at all other visits, subjects treated with DEX did better than PV for ocular itching scores post-CAC for all time points (P<0.05 at all visits except Visit 5, 3 minutes). These data are consistent with prior Phase 2 and Phase 3A studies. There were no serious AEs (ocular or non-ocular) and no subjects required rescue. There were no subjects with elevated IOP.
Conclusion
The primary endpoint of the trial was successfully met; DEXTENZA provided a sustained reduction in ocular itching, demonstrating promise as a potential hands-free steroid alternative for patients with allergic conjunctivitis. DEXTENZA was generally safe and well-tolerated in this study.