LYTENAVA Receives FDA Approval for Wet AMD

Outlook Therapeutics has received FDA approval for LYTENAVA (bevacizumab-vikg), making it the first and only FDA-approved ophthalmic bevacizumab formulation specifically developed for the eye to treat wet age-related macular degeneration in the United States. The approval marks the culmination of a long regulatory journey that included three prior complete response letters and a Formal Dispute Resolution with the FDA before success. CEO Bob Jahr described the milestone as defining for both physicians and patients, emphasizing that LYTENAVA provides an FDA-approved, eye-specific bevacizumab option with robust clinical evidence and validated manufacturing. The company also announced plans to launch a commercial franchise and expects 12 years of reference product exclusivity under the Biologics Price Competition and Innovation Act. Coverage notes that this approval could establish a new standard for bevacizumab therapy in wet AMD, given its dedicated ophthalmic formulation and regulatory oversight. Overall, the development represents a significant regulatory milestone and a potential shift in retina care toward a formalized, FDA-approved bevacizumab option for the eye.