Subgroup Analyses of Intracameral Phenylephrine and Ketorolac Injection: Results Based on Pooled Data From 3 Randomized Controlled Clinical Studies
Purpose
An analysis of potential treatment effects within subgroups of subjects enrolled in three randomized controlled studies of OMS302 (Omidria [phenylephrine and ketorolac injection] 1%/.03%) in subjects undergoing cataract surgery or intraocular lens replacement (ILR) was performed.
Methods
Data from 3 prospective, controlled, randomized clinical studies of OMS302 in subjects undergoing cataract extraction/replacement or refractive lens exchange surgery were pooled and subgroup analyses of two co-primary efficacy endpoints, mean area-under-the-curve (AUC) change from baseline in intraoperative pupil diameter and mean AUC for ocular pain VAS scores, were performed. Subgroups included age (<65, ≥65, <75, ≥75 years); lens opacities classification system (LOCS) II grade (high, low); gender; race (White, non-White); iris color (brown, blue, hazel, green, grey, other); and other eye disease (presence, absence). A total of 919 subjects (461 placebo and 458 OMS302) were included.
Results
For each subpopulation with at least 5% of subjects from the placebo and OMS302 treatment groups represented, the results of the subgroup analyses were similar and generally consistent with the overall results for the pooled co-primary efficacy endpoints. Across subgroups, the mean AUC change-from-baseline in intraoperative pupil diameter reanged from -0.7 to -0.4 mm for placebo vs 0 to 0.2 mm for OMS302 (overall:-0.51 mm vs 0.09 mm, respectively) and the mean AUC for ocular pain VAS scores ranged from 6.1 to 10.5 mm for placebo vs 3.8 to 6.0 mm for OMS302 (overall: 9.13 vs 4.19 mm, respectively)
Conclusion
Results of the subgroup analyses support the conclusion that the treatment effect of OMS302 is consistent accross subpopulations and that the results of the clinical studies performed may be generalizable across these groups.