FDA approves first ophthalmic bevacizumab for wet AMD

The FDA approved the first ophthalmic formulation of bevacizumab for the treatment of wet AMD.
The approval provides an FDA-approved bevacizumab developed specifically for the eye, replacing reliance on repackaged intravenous formulations.
The product is expected to be available to eligible U.S. patients before year-end, supported by reimbursement and patient assistance programs.

FDA approves Eysuvis for short-term treatment of dry eye disease

The U.S. Food and Drug Administration has approved Lytenava (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD), making it the first FDA-approved ophthalmic formulation of bevacizumab for wet AMD in the United States, according to a press release.

According to Outlook Therapeutics, the approval provides retina specialists with a bevacizumab formulation developed specifically for intravitreal use, rather than repackaged intravenous bevacizumab. The company said the product is supported by clinical data, validated manufacturing, FDA-approved labeling, and regulatory oversight, and expects Lytenava to receive 12 years of Reference Product Exclusivity under the Biologics Price Competition and Innovation Act.

Bevacizumab is widely used as a first-line anti-VEGF therapy for wet AMD despite the lack of a previously approved ophthalmic formulation. Outlook Therapeutics said it is preparing a commercial launch that includes reimbursement and patient support programs. Lytenava is expected to become available to eligible U.S. patients before the end of the year.

Read the full press release here.