Ocular Therapeutix (NSDQ:OCUL) said today it received a complete response letter from the FDA denying approval for its Dextenza for an indication for treating ocular pain occurring after ophthalmic surgery.
Ocular Therapeutix’s Dextenza, formerly known as OTX-DP, is designed to deliver sustained dosage of dexamethasone over 4 weeks using a hydrogel plug inserted into a tear duct. The plug then dissolves and is flushed from the body as tears.
The Bedford, Mass.-based company said the FDA raised concerns related to “deficiencies in manufacturing process and controls” which were identified during a pre-New Drug Application approval inspection of its manufacturing facility.
Ocular Therapeutix said the FDA’s letter did not provide details as to which manufacturing deficiencies remain open since the company’s last response.
“We have previously responded to all requests in an effort to address the manufacturing items raised by the FDA during the application process, and we await completion of the review. Importantly, there were no clinical issues identified in the CRL pertaining to efficacy or safety related to the post-surgical pain indication. Labeling discussions with the FDA are ongoing. We remain optimistic that Dextenza will be approved once these open manufacturing items are closed. We will continue to work collaboratively with the FDA so they can finalize their review of our NDA, and are committed to bringing Dextenza to market as rapidly as possible,” CEO Amar Sawhney said in a press release
The company said it will be required to resolve the manufacturing deficiencies identified during the FDA facility inspection before its NDA will be approved, and clarified that the FDA’s letter did not identify “any efficacy or safety concerns with respect to the clincial data provided in the NDA” and that it does not need any additional clinical trials to win FDA approval.
In June, Ocular Therapeutix saw shares dive over 40% after reporting the 2nd phase 3 clinical trial of its Dextenza drug-device combination failed to meet its primary endpoint.
The primary endpoint for the company’s 2nd Phase III trial of the device, which was exploring the efficacy of the device at treating ocular itching for patients with allergic conjunctivitis, was a significant reduction in ocular itching at 7, 14 and 21 days, the company said.
Results from the study indicated a lower, but not statistically significant difference between the placebo group and those implanted with Dextenza, Ocular Therapeutix reported.
This isn’t the 1st miss for Ocular Therapeutix, which failed to meet a key endpoint during the 2nd clinical trial exploring the efficacy of the device for treating pain & inflammation following cataract surgery.