Posters

Vision recovery after cataract surgery with an dexamethasone intracanalicular insert (0.4 mg) for the treatment of ocular inflammation and pain

Poster Details

First Author: E.Donnenfeld USA

Co Author(s):    S. Silverstein   J. Hovanesian   S. Bafna   S. Vantipalli   J. Metzinger   M. Goldstein     

Abstract Details

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 replace corticosteroid topical drops. Here we characterize the visual outcomes following administration of a dexamethasone intracanalicular insert (0.4 mg) in the treatment of post-surgical inflammation and pain after cataract surgery.

Setting:

Integrated analysis of one phase 2 and three phase 3, prospective, multicenter, double-masked, parallel-arm, vehicle-controlled clinical trials.

Methods:

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), 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%).

Conclusions:

Rapid visual acuity improvement after cataract surgery is a critical element of maximizing patient satisfaction with modern day cataract surgery. Visual outcomes with the dexamethasone intracanalicular insert following cataract surgery were 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.

Financial Disclosure:

is employed by a for-profit company with an interest in the subject of the presentation, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented