What Lytenava FDA approval means for compounded bevacizumab in AMD
Hamza Shah, OD, MS, FAAO, and Carolyn Majcher, OD, FAAO, weigh in on the recent FDA approval of the drug, which has been used off-label by compounding pharmacies for nearly 2 decades.
The FDA approval of Lytenava (bevacizumab-vikg; Outlook Therapeutics) marks the first ophthalmic-specific formulation of a molecule optometrists have watched anchor neovascular AMD management for nearly 2 decades. After 3 Complete Response Letters (CRL) and clinical trials including NORSE TWO and NORSE EIGHT, the approval raises pressing questions about pricing, access, liability, and whether an on-label product can displace the compounded bevacizumab long favored for its low cost. Hamza Shah, OD, MS, FAAO, and Carolyn Majcher, OD, FAAO, spoke with Optometry Times about what the approval signals for the regulatory bar, day-to-day practice, and the future of off-label use in retinal care.