Outlook Therapeutics Gets FDA Rejection on Its Ophthalmologic Bevacizumab Formulation

The quest for a manufactured ophthalmologic version of bevacizumab continues. The use of compounded bevacizumab has been considered a low-cost alternative to ranibizumab for the treatment of wet age-related macular degeneration (AMD). This may comprise up to half of the wet AMD utilization.

Outlook Therapeutics, which has sought to bring its ONS-5010 product to market, announced that it received a complete response letter (CRL) from the FDA. In a press release, the manufacturer acknowledged “several [chemistry manufacturing and control] issues, observations from preapproval manufacturing inspections, and a lack of substantial evidence.”

Outlook Therapeutics believes all of the issues raised by the CRL on ONS-5010 are addressable, and it is seeking a Type A meeting with the FDA for more clarification, especially regarding the need for any additional clinical evidence. Outlook had submitted data on three clinical trials, and the FDA acknowledged that the NORSE TWO pivotal trial met its safety and efficacy endpoints.

Outlook anticipates ONS-5010 will compete with Lucentis® and the ranibizumab biosimilars (Byooviz®, Cimerli®). In the short term though, Outlook’s stock price lost nearly 80% of its value, to $0.27 per share, based on this news.  

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.