Outlook Therapeutics Wins FDA Approval for LYTENAVA, First Ophthalmic Bevacizumab for Wet AMD

Outlook Therapeutics said in a filing that the U.S. Food and Drug Administration has approved LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration, making it the first FDA-approved ophthalmic formulation of bevacizumab in the United States.

According to the filing, the approval covers neovascular age-related macular degeneration, commonly known as wet AMD, and gives retina specialists and patients access to an FDA-approved ophthalmic bevacizumab developed specifically for the eye, supported by clinical evidence, validated manufacturing, approved labeling and ongoing FDA oversight.

The company said in the filing that it anticipates LYTENAVA will receive 12 years of Reference Product Exclusivity under the Biologics Price Competition and Innovation Act. Outlook Therapeutics said bevacizumab already accounts for the majority of first-line anti-VEGF treatment in wet AMD, and the company believes the approval positions LYTENAVA to become the new FDA-approved standard for bevacizumab therapy in this patient population.

CEO Bob Jahr said in the filing that physicians previously relied on repackaged formulations intended for intravenous use, and that LYTENAVA is a purpose-built ophthalmic formulation designed for intravitreal administration. Firas M. Rahhal, MD, Chairman of Ophthalmology at Good Samaritan Hospital in Los Angeles, was also quoted in the filing saying the retina community had been waiting a long time for an FDA-approved ophthalmic bevacizumab option.

The filing states that LYTENAVA enters the U.S. anti-VEGF retina market, estimated at approximately $8.5 billion annually, with millions of intravitreal injections administered each year. Outlook Therapeutics said it is now executing the commercial launch of LYTENAVA, including expanding reimbursement and patient support access and building a specialized retina commercial organization.

According to the filing, the company expects to make LYTENAVA available to eligible patients in the United States before year-end. The filing also notes that LYTENAVA has previously received a centralized Marketing Authorization from the European Commission and a Marketing Authorization from the UK's Medicines and Healthcare products Regulatory Agency for the treatment of wet AMD, and that the company has commenced commercial launch of the product in Germany, Austria and the UK.