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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.
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.
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.
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.