Meeting the study’s primary and secondary efficacy endpoints, Prolensa produced statistically greater clearing of subjects’ ocular inflammation by Day 15 and a greater proportion of subjects that were pain free at one day post-cataract surgery than placebo.
ISTA presented similar data from its first Phase 3 study in a symposium in the US. Data from both studies were collected under a common protocol and conducted and analyzed as two independent studies in the US.
ISTA is planning to file a New Drug Application with the US Food and Drug Administration for Prolensa in the first half of 2012 based on the results of the two Phase 3 studies.
The second study demonstrated that there were no serious drug-related ocular or systemic adverse events, and that the safety profile was consistent with ISTA’s currently marketed once-daily topical NSAID compound, Bromday.
Each of the Phase 3 multi-center, randomized, double-masked, parallel-group controlled study enrolled 220 subjects who underwent cataract surgery in one eye (unilateral).
The study evaluated ocular inflammation using a summed ocular inflammation score (SOIS) and was measured by an assessment of cells in the anterior chamber of the eye and cellular protein.
It assessed safety based on several variables, including adverse events, ophthalmic evaluations, and Ocular Comfort Grading Assessment (OCGA), and evaluated secondary efficacy endpoint via a pain score from OCGA recorded in a patient’s diary.