Outlook Therapeutics (OTLK) said Friday the US Food and Drug Administration has approved Lytenava for the treatment of neovascular age-related macular degeneration, commonly known as wet AMD, which is a chronic, progressive retinal disease.
The company said it expects the approval to grant Lytenava 12 years of reference product exclusivity under the Biologics Price Competition and Innovation Act.
Outlook Therapeutics said it is now executing the commercial launch of Lytenava and expects to make the ophthalmic formulation of bevacizumab available to eligible US patients before year-end.
Price: $1.58, Change: $+0.26, Percent Change: +19.32%