Ocular slapped with CRL despite last-ditch efforts
Ocular Therapeutix received a second CRL for its drug, Dextenza, despite submitting a last-minute application for an extension to its NDA. The effort was not enough, as the FDA referred to deficiencies in manufacturing process and analytical testing in the production stages of the drug to reject the application.
Dextensza is a dexamethasone-releasing insert that is placed through the punctum, the natural opening in the eyelid. On the occasion that the drug is approved, this means that patients could receive dexamethasone without the need for eye drops. The question of of who would feel more squeamish about taking eye drops over having an implant directly into the eye itself is whole other issue.
In this case, Ocular had several issues red flagged after an inspection at its facility before a decision on its NDA. With these issues having brought up in May, the last-ditch attempt to extend the NDA application always seemed likely fail – though this did not stop shares spiking nearly 26% on the announcement of the amendment to the NDA, only for the share price to be crushed 32% on the failure.
Ocular had altered its application to suggest it had rectified all of the issues noted in the Form FDA-483. However, this was not reviewed before the FDA made its decision on the NDA, as noted in a press release.
The company were careful to point that no efficacy or safety issues were mentioned regarding the clinical trial data provided by the company.
“We are evaluating the FDA’s response and plan to work closely with the agency in an effort to satisfy the requirements related to the NDA,” said Ocular Therapeutix CEO, Amar Sawhney. “Importantly, there were no clinical issues identified in the CRL pertaining to efficacy or safety related to the post-surgical pain indication. We believe that Dextenza can be approved once these open manufacturing items are resolved.”
If the manufacturing issues have been adequately resolved, the company can take some comfort that the process of re-application should be painless. However, it is unlikely that this will soothe the fact that the process could well continue late into 2018.
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