Outlook Therapeutics (NASDAQ:OTLK) Inc has said its chief operations officer Terry Dagnon will discuss the company’s wet age-related macular degeneration (AMD) drug Lytenava as part of a panel at the 2022 World Retina Conference later this month.
The conference is taking place from May 12-15, 2022, in Fort Lauderdale, Florida. Dagnon’s segment is part of a session called Retina Unplugged and scheduled for 8.05am ET on May 12.
The company said Dagnon will review Outlook Therapeutics (NASDAQ:OTLK)’ Lytenava (ONS-5010 or bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab currently under development to be administered as an intravitreal (read: into the back of the eye) injection for the treatment of wet AMD and other retinal diseases.
READ: Outlook Therapeutics says BioLexis reorganization results in GMS Holdings becoming its largest shareholder
“ONS-5010 is the first bevacizumab molecule specifically formulated and optimized to meet [US Food & Drug Administration] standards for ophthalmic intravitreal injection,” Dagnon said in a statement. “Over the course of its development, there has been some misperception within the retina community as to whether ONS-5010 is a biosimilar to Avastin (bevacizumab); however, with no FDA-approved ophthalmic indications for Avastin, a biosimilar regulatory pathway is not legally possible.”
In March 2022, Outlook Therapeutics announced its submission of a new Biologics License Application (BLA) for ONS-5010 to the US Food & Drug Administration (FDA). If the BLA is approved, it is expected to result in 12 years of marketing exclusivity for ONS-5010 as the first and only ophthalmic formulation of bevacizumab approved by the FDA to treat wet AMD, the company said.
“While off-label repackaged IV bevacizumab is widely used for retina diseases, it is not currently formulated or approved for ophthalmic use and these repackaged versions are widely known to be associated with public health concerns due to FDA compliance and safety issues,” Dagnon noted.
Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com
Follow him on Twitter @andrew_kessel