Ocular Therapeutix Dextenza NDA accepted by FDA

Ocular Therapeutix (NSDQ:OCUL) said today the FDA accepted the new drug application for its drug-device combo Dextenza for treating ocular pain following ophthalmic surgery. Bedford, Mass.-based Ocular Therapeutix’s Dextenza, formerly known as OTX-DP, is designed to deliver sustained dosage of dexamethasone over 4 weeks using a hydrogel plug inserted into a tear duct. The plug then dissolves and is flushed from the body as tears. “We are pleased that Ocular Therapeutix’s first NDA filing with our lead product candidate, Dextenza, has been officially accepted for review by the FDA. This is an important milestone for the Company and we will continue to work diligently with the FDA as they complete their review. Dextenza would provide a full post-operative course of therapy with one-time administration as compared to the current standard of care, which requires a complex and tapering regimen of multiple eye drops on a daily basis. We are excited to potentially offer both surgeons and their patients a novel alternative to steroid eye drop therapy,” CEO Amar Sawhney said in a press release. Ocular Therapeutix said the acceptance indicates that no issues which could cause a serious delay of the review process have been identified, and the FDA set a target action date of July 24, 2016 for potential FDA approval of Dextenza. “Dextenza is designed to give a patient an entire 30-day course of medication with a single application of a depot, placed by the doc...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Optical/Ophthalmic Food & Drug Administration (FDA) Regulatory/Compliance Ocular Therapeutix Source Type: news