Outlook Therapeutics said the FDA reversed course on its reformulated Avastin version for wet age-related macular degeneration (AMD) after three prior rejections dating back to 2023. The company indicated that the agency concluded “substantial ...” in the latest FDA communication, which Outlook framed as opening the door for a potential approval path. The update matters for wet AMD because Avastin biosimilar-style competition and reformulation strategies can shift access and cost dynamics for long-running intravitreal treatment paradigms. It also highlights how reformulated biologics can face extended regulatory review cycles, particularly when prior applications were challenged. With the agency’s position reportedly changing, Outlook’s next step will be to translate the FDA feedback into a complete, resubmitted regulatory posture. Market participants will likely focus on whether the FDA’s reversal changes label expectations, manufacturing comparability requirements, and timing for any final decision.