1. Scrip
  2. >>Therapy Areas
  3. >>Sensory

Outlook Eyes Blockbuster-Sized Sales For An Old Eye Drug In Wet-AMD

 
• By Jessica Merrill

The company is seeking FDA approval for a first-time ophthalmic formulation of bevacizumab and also refiled its BLA.

eye
Outlook refiled a BLA for bevacizumab for wet-AMD • Source: Shutterstock

Outlook Therapeutics, Inc. believes it has a straightforward commercial opportunity on its hands if it can become the first to win US Food and Drug Administration approval for an ophthalmic formulation of bevacizumab, even though the VEGF inhibitor has long seen off-label use to treat wet age-related macular degeneration (AMD) and other retinal diseases, and the market is already highly competitive.

The company announced on 30 August that it has re-filed a biologics license application (BLA) for its bevacizumab formula ONS-5010, which it hopes to market as Lytnava if it receives approval. Outlook said in May that it had voluntarily withdrawn the BLA after discussions with the FDA, assuring investors at the time that it would re-file the application by September, a goal the company appears to have met

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Sensory

Merck & Co. CMO Barr On Breaking Into Immunology And Ophthalmology

 
• By Jessica Merrill

Chief medical officer Eliav Barr discussed Merck’s investment in new therapeutic areas and business development in an interview with Scrip.

In Brief: US FDA Rejects Regeneron’s Bid to Extend Eylea HD Dosing

 
• By Sushmita Panda

Regeneron is disappointed by the knock-back for longer dosing intervals for its high-dose version of Eylea, but its supplemental application for a more commercially important shorter four-week regimen has received a priority review.

Outlook Holds Out Hope For Wet AMD Approval Despite Phase III Topline Miss

 
• By Alaric DeArment

The company said the NORSE EIGHT trial of ONS-5010 did not meet the primary endpoint of showing noninferiority to ranibizumab, but it still plans to file for US FDA approval.

GSK’s Linerixibat GLISTENs In PBC Itching

 
• By Elizabeth Cairns

But differences in trial design means it is hard to handicap GSK’s product against Mirum’s volixibat.

More from Therapy Areas

AstraZeneca COPD Drug Breztri Breezes Through Asthma Trials

 
• By Kevin Grogan

The triple therapy improves lung function in the Phase III KALOS and LOGOS studies

Zepbound Grows, But CVS/Novo Nordisk Deal For Wegovy Casts Shadow

 
• By Alaric DeArment

Lilly executives told the company’s Q1 call they were not surprised at the Wegovy deal, but some analysts said it could cut into prescription growth for Zepbound.

GSK Talks Up Nucala COPD Hospitalization Data In Challenge To Dupixent

 
• By Kevin Grogan

As the PDUFA date for the UK major’s IL-5 inhibitor draws close.