Eyeing an FDA filing, Ocular Therapeutix drug hits PhIIIa goals

Ocular CEO Amar Sawhney

Ocular Therapeutix ($OCUL) says that its lead eye therapy successfully wrapped the first of two Phase III studies, reducing inflammation and pain among a group of patients after cataract surgery. And with the second late-stage trial due to report out in a matter of weeks, the biotech says it remains on track to file for an approval in Q2.

Of the 247 patients recruited for the trial, investigators say that a third of the patients treated with OTX-DP--a plug designed to deliver the steroid dexamethasone to the eye over a period of 4 weeks--had no inflammatory cells in the anterior chamber of the study eye two weeks after treatment. Slightly less than half that rate among the placebo arm achieved the same goal. On day eight 76.1% of the drug study arm reported no pain compared to 36.1% in the placebo group.

The Bedford, MA-based Ocular spelled out its biobetter business plan when it filed its IPO last year. The company has developed a hydrogel formulation that's designed to provide prolonged dosing for eye therapies, replacing the drops that are typically in use. And they are taking this approach with four clinical-stage programs, including a project for chronic allergic conjunctivitis. The biotech has one product on the market, ReSure Sealant, which is approved to close corneal incisions after cataract surgery.

Ease of administration may sound like an improvement for patients, but as payers dig in--willing to trade off on things like more complex dosing in exchange for lower prices--that may be a hard sell in the U.S. That argument may help explain why the biotech's share price slid a few points this morning. But Ocular is sticking to its strategy.

"The ability to administer the entire course of therapy for post-operative inflammation and pain with a single dose would remove the onus from patients to follow complex pharmaceutical dosing regimens while providing the desired tapered therapeutic effect," says Ocular CEO Amar Sawhney in a statement. "If we also achieve positive results in our Phase IIIb clinical trial, for which we expect to announce topline results by the end of March, we remain on track to submit an NDA to the FDA for OTX-DP for post-surgical ocular inflammation and pain in the second quarter of 2015."

Ocular had to price at the low end of its range when it went public last summer, settling for $13 a share. But ahead of the data release its stock had enjoyed the burst of enthusiasm shared by many in the sector, rising to more than $40 a share. The biotech's IP was in-licensed from Incept, a firm that is half-owned by Sawhney.

- here's the release