Shares in Ocular Therapeutix (NSDQ:OCUL) surged this morning after the biopharmaceutical company met expectations on Wall Street with its 3rd-quarter results and announced it will re-submit its new drug application to the FDA for Dextenza, its post-surgical ocular pain reliever, by the end of the year.
In July, the FDA denied approval for Ocular’s hydrogel plug designed to deliver a sustained dosage of dexamethasone over 4 weeks following ophthalmic surgery.
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.
“Following productive discussions with the FDA, we are preparing for the resubmission of our NDA for Dextenza for post-surgical ocular pain by the end of the year,” chairman, president & CEO Amar Sawhney said in prepared remarks. “We are also pleased to have commenced patient enrollment in our 1st Phase III clinical trial with OTX-TP for the treatment of glaucoma and ocular hypertension. We believe that this is the 1st Phase III clinical trial to be conducted with a non-invasive, sustained-release drug candidate for the treatment of glaucoma, and our goal is to address the major issue of low patient compliance rates associated with currently approved topical therapies. Further, we are excited to have entered into a strategic collaboration with Regeneron to develop a potential 1st-in-class sustained-release protein-based anti-VEGF hydrogel injection for the treatment of wet AMD and other serious retinal diseases.”
OCUL shares were trading at $5.82 apiece today in early afternoon trading, up 11%.
