Ocular Therapeutix (Nasdaq: OCUL) will submit a New Drug Application (NDA) to the US Food and Drug Administration for Dextenza (dexamethasone) in the first quarter of 2017.
The US-based biopharmaceutical company is focused on the development of therapies for diseases and conditions of the eye. Dextenza is designed to treat post-surgical ocular inflammation and pain, through a bioresorbable intracanalicular insert that provides drug release to the surface of the eye over a period of several weeks.
The decision to submit the NDA comes on the back of more positive results from a Phase III clinical trial, in which the test group demonstrated superior secondary endpoints at all measured timepoints. The drug has also exhibited a favorable safety profile.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze