Ocular Therapeutix price tumbles on FDA rejection of Dextenza

US ophthalmology specialist Ocular Therapeutix (Nasdaq: OCUL) saw its share price plummet by 14.5% to $4.42 on Monday after announcing that the Food and Drug Administration had not approved its New Drug Application (NDA) for Dextenza (dexamethasone insert), the company’s lead candidate.

The NDA for Dextenza is for intracanalicular use in the treatment of ocular pain occurring after ophthalmic surgery, and Ocular Therapeutix has stressed that the FDA did not raise any efficacy or safety issues with respect to the clinical data provided in the application, nor suggest any need for additional clinical trials, in its Complete Response Letter (CRL) to the company.

Instead, the FDA brought up concerns with deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility.