Shares in Ocular Therapeutix (NSDQ:OCUL) rose more than 5% today after the company said its Dextenza post-surgical ocular pain relief implant met primary endpoints in the company’s most recent Phase III trial.
The hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following ophthalmic surgery.
The FDA is slated to make a decision whether or not to approve Dextenza for the treatment of ocular pain after ophthalmic surgery by July 19, 2017.
The Phase III trial enrolled 438 patients undergoing clear corneal cataract surgery and randomized them to receive Dextenza or a placebo implant. Primary efficacy endpoints compared the 2 groups for the absence of anterior chamber cells at day 14 and absence of pain after 8 days. Secondary efficacy endpoints included absence of anterior chamber cells, absence of ocular flare and absence of ocular pain throughout the 30-day treatment period.
Dextenza was statistically better than the placebo, Ocular reported. More than 52% of patients treated with Dextenza had no AC cells after 14 days, compared to 31.1% of the placebo recipients. Nearly 80% of patients in the Dextenza group reported no pain at Day 8, versus 61.3% of their counterparts in the control group.
There were no treatment-related serious adverse events, according to the company, and the insert was well tolerated.
“Dextenza’s safety and efficacy profile, combined with a positive patient experience, provide a strong foundation for offering an alternative to current post-operative steroid eye drops, which are associated with compliance issues,” president, chairman & CEO Amar Sawhney said in prepared remarks. “If approved, Dextenza may reduce the patient burden of administering topical eye drops following ophthalmic surgery by enabling physicians to control the entire course of steroid therapy with a single administration.”
The company also commissioned a qualitative patient experience survey among 25 patients. Ocular said that 92% of patients reported the highest level of satisfaction with the device and would recommend it to family and friends. The company added that 96% of patients reported the highest level of satisfaction with regard to convenience.