Outlook tanks as the FDA issues CRL on ONS-5010 for wet AMD
US ophthalmology focused biotech Outlook Therapeutics (Nasdaq: OILK) saw its shares closed down more than 80% at $0.27 yesterday, after it revealed that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to the company’s biologic license application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet age-related macular degeneration (AMD).
ONS-5010 is the first specific ophthalmic formulation of bevacizumab, a monoclonal antibody cancer treatment that is sold by Roche (ROG:SIX) under the brand name Avastin, and is used off-label for the treatment of AMD. If approved, Outlook’s product will be branded as Lytenava.
Confirmatory trials required
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