- Micro cap Ocular Therapeutix (NASDAQ:OCUL) perks up 9% premarket on modestly higher volume in response to its announcement of additional data from its Phase 3 study assessing DEXTENZA (dexamethasone insert) 0.4 mg for the treatment of post-surgical ocular inflammation and pain. The company initially reported successful results in November.
- DEXTENZA met a secondary endpoint of demonstrating superiority to placebo at all measured time points in an indicator of inflammation called anterior chamber (AC) flare. Specifically, ~46% of the treatment group showed an absence of AC flare at day 4 after insertion. Statistically significant differences in AC flare compared to placebo were observed on days 4, 14 and 30 post insertion. The difference at day 2 fell short of statistical significance.
- The company is working through a CRL it received in July from the FDA in response to its marketing application.
- Previously: Ocular Therapeutix's Dextenza successful in late-stage study in post-surgical ocular inflammation and pain; shares ahead 24% premarket (Nov. 14, 2016)