Outlook Therapeutics Inc. (OTLK) is gearing up for its third shot at FDA approval for ONS 5010, an ophthalmic formulation of bevacizumab administered as an intravitreal (IVT) injection for the treatment of wet age-related macular degeneration, with a regulatory decision expected on December 31, 2025.Roche's Bevacizumab, sold under the brand name Avastin among others, is a drug used to treat various forms of cancer. It is also used off-label to treat eye diseases like wet age-related macular degeneration. Since there are no approved ophthalmic formulations of Bevacizumab, clinicians wishing to treat retinal patients with Bevacizumab have to use unapproved repackaged IV Bevacizumab provided by compounding pharmacies. This approach carries risks of contamination and inconsistent potency and availability.ONS 5010 was approved in the European Union in May 2024 and in the UK in July 2024 and is marketed under the brand name Lytenava.As mentioned above, this is the company’s third attempt to secure approval for ONS 5010 in the U.S.The FDA declined to approve ONS 5010 in 2023, citing several Chemistry, Manufacturing, and Controls (CMC) issues, unresolved issues from pre-approval manufacturing inspections, and a lack of substantial evidence. Outlook Therapeutics resubmitted the biologics license application addressing these concerns, but the FDA again declined approval in August 2025, this time citing a single deficiency: insufficient evidence of effectiveness.The company completed the Type A Meeting with the FDA this September and discussed the complete response letter issued in August 2025 and now awaits the agency’s final decision.OTLK closed Wednesday’s (November 26, 2025) trading at $1.68, up 5%.