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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,...

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In Brief: Nanoscope Ploughs Forward With FDA Application For Retinitis Pigmentosa Gene Therapy

 
• By Manas Mishra

Nanoscope’s experimental gene therapy, MCO-010, is designed to target the broader retinitis pigmentosa population, regardless of the underlying gene mutation, with a completed US regulatory submission expected in early 2026.

In Brief: 4DMT Fast-Tracks Long-Acting Wet AMD Therapy Trials, Cuts 25% Of Workforce

 
• By Sushmita Panda

4D Molecular Therapeutics has fast-tracked its Phase III trials for 4D-150 in wet AMD, with top-line data from one now expected in H1 2027 and another underway ahead of schedule. The company is also cutting a quarter of its staff as it focuses on its late-stage pipeline and to help fund the trials.

In Brief: Opus Gears Up For FDA Filing In Presbyopia

 
• By Sushmita Panda

Data from a second pivotal trial support a filing in the US for Opus Genetics’ phentolamine ophthalmic solution, to treat presbyopia.

Bayer Buoyant After EU Nod For Twice-Yearly Eylea

 
• By Kevin Grogan

Green light follows a recent rejection by the US FDA to partner Regeneron's request for an extension to the dosing interval.

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Bayer’s Kerendia Gains Blockbuster Indication For Heart Failure

 
• By Joseph Haas

New US approval in heart failure with preserved or mildly reduced ejection fraction should add to Kerendia’s earning power on top of chronic kidney disease indication.

Takeda Prepares Ground For Oveporexton In Narcolepsy

 
• By Alaric DeArment

The drugmaker announced positive results from two Phase III trials for the drug in narcolepsy type 1 that analysts said bode well for the OX2R agonist class as a whole.

Phase III Success For AstraZeneca’s $5bn Hypertension Hope Baxdrostat

 
• By Andrew McConaghie

Rivals Mineralys could be first to file but AstraZeneca is banking on its cardiovascular market know-how to lead the emerging class.