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Filed Under
Cataract
medication
inflammation
dexamethasone
intracameral antibiotic
post-operative
2020 paper presentation
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.
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.
View More Presentations from this Session
This presentation is from the session "SPS-111 Cataract Surgery - Medications" from the 2020 ASCRS Virtual Annual Meeting held on May 16-17, 2020.