Dexamethasone punctum plug resubmitted to FDA

Ocular Therapeutix today resubmitted a new drug application to the FDA for Dextenza, a bioresorbable intracanalicular dexamethasone insert for postop pain.

In July 2016, the FDA sent Ocular Therapeutix a complete response letter (CRL), which identified concerns over deficiencies in the manufacturing process observed during inspection. In resubmitting the application, the company says it has resolved those issues. The company expects a response in 1 to 2 months.

“Following productive discussions with the FDA, we are pleased to announce the resubmission of our NDA for Dextenza for the treatment of ocular pain occurring after ophthalmic surgery,” said Amar Sawhney, PhD, president and CEO at Ocular Therapeutix. “If Dextenza is approved, we believe that its ability to provide a complete course of steroid therapy with one-time administration in the post-surgical setting will be extremely attractive for both ophthalmologists and patients. We continue to build our commercial organization and infrastructure in preparation for the earliest possible launch of Dextenza, subject to marketing approval.”

The insert is placed through the punctum into the canaliculus, and is designed to deliver dexamethasone to the ocular surface for up to 30 days. Following treatment, it resorbs and exits the nasolacrimal system without need for removal.

Three phase 3 trials show that the insert provides significantly better control over inflammation and pain after cataract surgery compared with placebo.