FDA Accepts Ocular Therapeutix’s NDA for Dextenza Drug-Device Combo

The FDA has accepted for review Ocular Therapeutix’s NDA for Dextenza, a drug-device combination for the treatment of ocular pain after ophthalmic surgery.

The combo is designed to provide a 30-day course of medication with the placement of a depot in the tear punctum.

Ocular Therapeutix CEO Amar Sawhney says the treatment would provide “a full post-operative course of therapy with one-time administration,” while the current standard of care requires a complex regimen of multiple eye drops on a daily basis.

A PDUFA date has been set for July 24, 2016. — Michael Cipriano