Outlook Therapeutics announced the US Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the biologics license application (BLA) for ONS-5010 (Lytenava; bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD), or wet AMD. The company said in a press release it has been informed that the resubmission is a Class 1 review, with a PDUFA target action date of July 29, 2026.

If approved, ONS-5010 will be the first FDA-approved ophthalmic formulation of bevacizumab, the company said. Outlook Therapeutics has initiated prelaunch activities in anticipation of BLA approval. RP