The US Food and Drug Administration has accepted the resubmission of Outlook Therapeutics’ Biologics License Application for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment of neovascular ("wet") age-related macular degeneration (nAMD).

The FDA designated the resubmission as a class 2 review, initiating a 6-month review period and setting a target action date of August 27, 2025, under the Prescription Drug User Fee Act. If approved, the product will be marketed in the United States as Lytenava (bevacizumab-vikg) and is expected to receive 12 years of regulatory exclusivity.

Bevacizumab (Avastin; Genentech) was originally approved for cancer treatment in 2004. It has been used off-label since around 2005 to treat nAMD, following early clinical evidence and physician reports suggesting its effectiveness in reducing retinal fluid and improving vision.

ONS-5010 has already received marketing authorization in the European Union and the United Kingdom. The current resubmission follows guidance from the FDA and includes data from the NORSE EIGHT trial, a noninferiority study comparing ONS-5010 to ranibizumab in treatment-naïve patients, along with additional manufacturing and controls information.

Outlook Therapeutics’ interim CEO Lawrence Kenyon said in a press release that the FDA’s acceptance represents a key step in the company’s efforts to bring an on-label ophthalmic formulation of bevacizumab to US clinicians and patients. The company is continuing preparations for potential commercialization in the United States, while planning a second-quarter 2025 launch in the EU and UK. RP