FDA, Manufacturing

Ocular Therapeutix’s last-minute gambit fails to salvage its second FDA application, shares plunge

An 11th hour bid by Ocular Therapeutix to salvage its FDA application for their drug/device eye treatment Dextenza got shot down in a hurry on Tuesday.

A year after Ocular received its first rejection of the eye therapy based on manufacturing issues, the Bedford, MA-based company was handed its second complete response letter after inspectors flagged issues during a pre-NDA inspection a couple of months ago.

Ocular shares $OCUL took a nose dive on the news, dropping more than 30%.

Ocular execs tried to win a reprieve by filing a response to the FDA’s manufacturing concerns on Monday, the day ahead of the PDUFA date. They wanted regulators to flag the response as a major amendment to their application and extend the deadline, but the FDA stiff-armed the biotech without even taking a look — according to Ocular’s version of events.

Amar Sawhney

Dextenza has had a mixed Phase III record in the clinic, succeeding with its hydrogel plug in delivering dexamethasone over an extended period in reducing post-surgical pain, but failing at significantly reducing ocular itching for allergic conjunctivitis. Analysts have also been scratching their heads over the commercial prospects of a therapy available in cheap eye drops.

None of that gets answered, though, before the company wins a regulatory green light. And now the biotech, which is partnered with Regeneron on an extended dosing approach for Eylea, will once again have to go back to the drawing board over its manufacturing woes as it preps for a third shot at an OK.

Said Ocular Therapeutix CEO Amar Sawhney:

Importantly, there were no clinical issues identified in the CRL pertaining to efficacy or safety related to the post-surgical pain indication. We believe that DEXTENZA can be approved once these open manufacturing items are resolved.


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RAPS Regulatory Convergence 2017