Chardan initiated coverage on Outlook Therapeutics Inc (NASDAQ:OTLK) with a Buy rating and a price target of $10 based on the company’s commercial potential with its lead ophthalmic formulation of ONS-5010 (bevacizumab, Avastin), an anti-VEGF antibody in development for wet age-related macular degeneration (wet AMD).
The company recently re-submitted the marketing application with the FDA for ONS-5010. It expects to learn of a potential PDUFA date by the end of October, with the potential FDA approval in late August 2023.
Chardan notes that ONS-5010 is being developed as an ophthalmic formulation of Roche Holdings AG’s (OTC: RHHBY) Avastin (bevacizumab) that was initially approved in 2004 for metastatic colorectal cancer.
But it has been widely adopted for off-label use by eyecare practitioners as an effective treatment for several retinal diseases.
Despite several approved anti-VEGF treatments available for wet AMD, off-label Avastin remains the treatment of choice, accounting for ~50% share of the anti-VEGF market, primarily driven by comparable efficacy and safety at a much lower cost ($50-$100 for Avastin injection compared to ~$2k for treatments from Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Novartis AG (NYSE:NVS).
We believe it is unlikely that practitioners will move away from bevacizumab, so providing an option for an FDA-approved ophthalmic formulation of the drug at a reasonable price point would likely be met with enthusiasm.
Price Action: OTLK shares are up 6.25% at $1.19 on the last check Tuesday.
Photo by Aline Berry from Pixabay
