Ocular Therapeutix Falls 30% After Major Setback In Dextenza

Shares of Ocular Therapeutix Inc OCUL were trading lower by more than 30 percent heading into Wednesday's open after the biopharmaceutical company confirmed a major setback for its eye drug Dextenza, a therapy used for the treatment of ocular pain following ophthalmic surgery.

Ocular confirmed in a press release after Tuesday's close it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration relating to its re-submission of a New Drug Application (CRL) for Dextenza.

The CRL states that the FDA can't approve the company's NDA in its present form. The regulatory agency cited deficiencies in manufacturing processes and analytical testing relating to the manufacturing of the drug, Ocular explained. An inspection of the company's manufacturing facility was completed in May and any future satisfactory resolution will be required before the NDA is approved.

However, the FDA's letter didn't identify any efficacy or safety concerns with respect to any clinical trial.

"We are evaluating the FDA's response and plan to work closely with the agency in an effort to satisfy the requirements related to the NDA," said Ocular Therapeutix President, Chief Executive Officer and Chairman, Amar Sawhney, Ph.D. "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."

The stock traded recently at $5.16, down 32 percent.

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