- The Food and Drug Administration has once again rejected Ocular Therapeutix's lead candidate for problems related to the drug's production.
- The eye-focused pharmaceutical developer disclosed receipt of a second complete response letter (CRL) for Dextenza (dexamethasone insert), a drug aimed at treating post-surgical ocular pain and inflammation, on Tuesday. Like the first CRL for Dextenza issued about a year ago, this newest setback was based on manufacturing deficiencies.
- "Importantly, there were no clinical issues identified in the CRL pertaining to efficacy or safety related to the post-surgical pain indication," Ocular CEO Amar Sawhney said in a Tuesday statement. "We believe that Dextenza can be approved once these open manufacturing items are resolved."
Ocular has had a rough time convincing U.S. regulators that its manufacturing capabilities for Dextenza are up to snuff. For example, the company was hit with a Form 483, which indicates some violation of the Food, Drug and Cosmetic Act, in May after the FDA found problems with a Dextenza production site during re-inspection.
In response, Ocular revealed on July 10 it had submitted a major amendment to the resubmitted New Drug Application (NDA) for Dextenza that it believed would put to bed the "outstanding issues regarding particulate matter."
The amendment centered around the modification of a piece of manufacturing equipment. Ocular plans to give regulators new commercial batch data to show the effects of updating the equipment, but — in the wake of that added data — also requested the July 19 target action date for Dextenza be pushed back three months.
This newest CRL also pertains to the manufacturing problems, which encompassed processing and analytical testing, observed during the FDA's site re-inspection in May.
Though the FDA had received Ocular's response, the agency claimed there wasn't enough time to review it before issuing the latest Dextenza rejection, according to the July 11 statement from Ocular. While the drugmaker must submit a different response for the CRL, Ocular noted that regulators said "applicable sections" of its Form 483 response could be incorporated.
These recent developments now beg the question: when exactly might Dextenza make it to market? For Ocular, not soon enough. The company needs new product blood in its portfolio, as it brought in paltry revenues of $475,000 during the first quarter.
Investors also appear to be getting impatient. Ocular shares took a 25% plunge on Wednesday morning, trading at $5.70 apiece.