Ocular Therapeutix, a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative therapies for diseases and conditions of the eye, presented ocular pain data from a pooled analysis from three phase III clinical trials evaluating the efficacy and safety of dextenza (dexamethasone insert) 0.4mg for intracanalicular use, for the treatment of ocular pain and inflammation following cataract surgery.
The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of July 19, 2017, for a decision regarding the potential approval of dextenza. The upcoming PDUFA date is for a New Drug Application (NDA) for the treatment of ocular pain following ophthalmic surgery based on a phase II study and two phase III trials. The third and most recent phase III study results are not currently being evaluated by FDA as part of the current NDA.
The pooled analysis includes data from all three phase III trials, in which 79% of dextenza patients reported no pain at Day 8 compared to 56.9% of the placebo patients. Across all three phase III trials, a greater proportion of placebo patients experienced at least one ocular adverse event (AE) as compared with dextenza patients. The most frequent ocular AEs were anterior chamber inflammation, increased intraocular pressure, corneal edema, and eye inflammation. There were no treatment-related serious adverse events (SAEs) in either group.
“The pooled safety and efficacy profile suggests that dextenza may offer an alternative to current post-operative steroid eye drops, which are associated with compliance issues,” said Jonathan H. Talamo, M.D., chief medical officer of Ocular Therapeutix. “If approved, dextenza has the potential to reduce the burden of administering topical eye drops following ophthalmic surgery, and to enhance patient and provider experience by enabling physicians to control the entire course of steroid therapy with a single insertion.”
Dextenza has been studied in three Phase 3 trials. All trials were prospective, multicenter, parallel-arm, double-masked, and vehicle-controlled to evaluate the safety and efficacy of dextenza for the treatment of ocular pain and inflammation following cataract surgery. In two trials, patients were randomized 2:1 (dextenza to placebo vehicle insert); while the in the most recent study patients were randomized 1:1. A total of 926 patients were enrolled (n=541, dextenza; n=385, placebo vehicle insert) who were undergoing clear corneal cataract surgery. Immediately following surgery, patients were randomized to insertion of either dextenza or a placebo insert. Primary efficacy endpoints evaluated the differences between the dextenza treatment group and the placebo group for the absence of anterior chamber cells at day 14 and absence of pain at day 8. Secondary efficacy endpoints included absence of anterior chamber cells, absence of ocular flare, and absence of ocular pain across relevant time points during the 30-day treatment period.