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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.
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.
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%).
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.