News

We provide the latest news
from the world of economics and finance

Back
22 March
Outlook Therapeutics Receives Positive CHMP Opinion For ONS-5010 To Treat Wet AMD

(RTTNews) - Outlook Therapeutics, Inc. (OTLK) announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has given a positive opinion on the approval of a new ophthalmic formulation of bevacizumab called ONS-5010/Lytenava also known as 'bevacizumab gamma.'

This new formulation is specifically designed to treat wet age-related macular degeneration or wet AMD in the European Union.

The CHMP's positive opinion was influenced by the outcomes of Outlook Therapeutics' wet AMD clinical program for ONS-5010, which included three successful registration clinical trials.

If authorized, ONS-5010 is anticipated to receive ten years of exclusive market rights in the European Union.

The company stated that it is also exploring direct sales and partnerships in Europe.

A decision from the European Commission is expected around 67 days after the CHMP opinion.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.