FDA rejects drug to treat post-surgical eye pain

The Food and Drug Administration denied approval for Bedford, Mass.-based Ocular Therapeutix's new eye drug Dextenza.

Dextenza is intended to treat ocular pain that occurs after ophthalmic surgery.

The FDA cited concerns regarding deficiencies in the company's manufacturing process of the drug. The agency did not identify any issues relating to the drug's safety or efficacy based on the company's clinical data.

"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," said Amar Sawhney, PhD, president, CEO and chairman of Ocular Therapeutix. "We remain optimistic that Dextenza will be approved once these open manufacturing items are closed."

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