Ocular Therapeutix (NSDQ:OCUL) said today that it resubmitted a New Drug Application to the FDA for its post-surgical ocular pain reliever. 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.
“Following productive discussions with the FDA, we are pleased to announce the resubmission of our NDA for Dextenza for the treatment of ocular pain occurring after ophthalmic surgery,” president, chairman & CEO Amar Sawhney said in prepared remarks. “If Dextenza is approved, we believe that its ability to provide a complete course of steroid therapy with 1-time administration in the post-surgical setting will be extremely attractive for both ophthalmologists and patients. We continue to build our commercial organization and infrastructure in preparation for the earliest possible launch of Dextenza, subject to marketing approval.”
Shares in the company surged in November after the biopharmaceutical company met expectations on Wall Street with its 3rd-quarter results.
The Bedford, Mass.-based company reeled in its losses to -$9.6 million, or -39¢ per share, on sales of $477,000 for the 3 months ended Sept. 30, paring its losses by 16.5% on sales growth of 11.2% compared to the same period last year.
Losses per share came in well ahead of the -51¢ consensus on The Street, where analysts were looking for sales of $460,ooo.
Later that month, the company said that Dextenza 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 Dextenza 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 Dextenza 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.
OCUL shares were trading at $7.48 apiece, down -5.7%.