Ocular Therapeutix (NSDQ:OCUL) said today that the FDA accepted the company’s resubmitted New Drug Application for its post-surgical ocular pain reliever, Dextenza. The hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following opthalmic surgery.
The Bedford, Mass.-based company has had trouble gaining regulatory approval for the pain relief drug-device combo – in July last year, the FDA denied approval for Ocular’s Dextenza, citing concerns related to “deficiencies in manufacturing process and controls” which were identified during a pre-New Drug Application approval inspection of its manufacturing facility.
The company reported that the FDA set its target action date, according to the Prescription Drug User Fee Act, for July 19 this year.
“We are pleased the FDA has accepted our resubmission of the Dextenza NDA and that we now have clarity on the PDUFA target action date. We look forward to advancing this process toward our goal of the potential approval and commercial launch of Dextenza,” president, chairman & CEO Amar Sawhney said in prepared remarks. “With nearly 4 million cataract surgeries performed in the U.S. in 2016 as our initial target, the market opportunity for Dextenza is significant. If approved, we believe Dextenza will be the 1st non-invasive therapy available to patients and ophthalmologists that can provide a full post-operative course of therapy with a single placement.”
In November last year, Ocular said that its pain relief implant met both primary endpoints in a pivotal trial for the treatment of post-surgical ocular inflammation and pain.
The randomized, double-masked study enrolled 438 patients who were undergoing clear corneal cataract surgery at 21 sites throughout the U.S to compare the insert with a sham control procedure.
Dextenza met its 2 primary efficacy endpoints for inflammation and pain – more than half of the patients treated with Dextenza showed an absence of inflammatory cells in the anterior chamber of the eye on day 14, compared to 31% of the patients who received the placebo vehicle control punctum plug. Over 75% of patients with the hydrogel plug reported absence of pain on day 8, compared to 61% of the control group.
The insert also met its safety endpoints, as there were no treatment-related serious adverse events reported in the trial. The Dextenza inserts were visible in almost all participants throughout the 30 day trial, with 99% present at the primary efficacy endpoint visits.