Ocular Therapeutix (Nasdaq: OCUL) staged a dramatic recovery Friday after receiving the FDA’s green signal for its ophthalmic drug DEXTENZA to include the treatment of ocular inflammation after ophthalmic surgery as an additional indication. The approval of the Supplemental New Drug Application submitted by the company clears the drug for the treatment of ocular inflammation, in addition to post-surgery pain.
The market responded positively to the announcement and the stock gained about 8% during the early trading hours, after closing the previous session sharply lower.
The application was submitted after the successful completion of three advanced stage clinical trials of DEXTENZA, a corticosteroid, which was found to be effective in a significant number of patients who underwent ophthalmic surgery.
The application was submitted after the successful completion of three advanced stage clinical trials on DEXTENZA
In November last year, the formulation was approved for the treatment of pain after ophthalmic surgery. DEXTENZA stands out for being the only FDA-approved drug in the category that is administered by delivering directly to the surface of the eye, doing away with eyedrops.
Commenting on the FDA approval, Ocular’s CEO Antony Mattessich said, “We could not be more excited about both the approval and its earlier-than-expected timing. With our C-Code and pass-through payment status effective on July 1, the expanded indication gives us tremendous momentum as we approach our commercial launch.”
The expansion of DEXTENZA is of significant importance for the company, which suffered a blow after a late-stage clinical trial on its ORX-TP eye insert recently failed to meet the primary endpoint of considerably reducing intraocular pressure.
The stock slipped to an all-time low last month after the company’s net loss widened in the first quarter, hurt by an increase in research and development expense, despite a 45% increase in revenues. Currently, the stock is trading down 46% from the levels seen a year earlier.