FDA rejects Ocular's Dextenza

Ocular Therapeutix Inc. (NASDAQ:OCUL) said it received a complete response letter from FDA for Dextenza ( OTX-DP) to treat ocular pain following ophthalmic surgery. Ocular said the agency cited "deficiencies in manufacturing process and controls," but no safety or efficacy concerns.

The company said it is working with FDA to resolve the CRL. Dextenza is a hydrogel-based punctum plug that delivers sustained- and tapered-release dexamethasone over one month. ...