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."
More articles on supply chain:
FDA approves Crestor's generic rivals, much to Astrazeneca's dismay
FDA approves Relistor to treat opioid-induced constipation
Supply chain tip of the week: Don't underestimate the power of tidbits and newsletters