Outlook Therapeutics (NASDAQ:OTLK) Inc has provided an update on its Biologics License Application (BLA) submission for ONS-5010/LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).
The pre-commercial biopharmaceutical company said it has confirmed the additional information necessary to re-submit the BLA for ONS-5010 by September 2022 following receipt of additional correspondence from the US Food and Drug Administration (FDA).
“The additional correspondence from the FDA confirms our commitment to our shareholders to re-submit a completed BLA to FDA by September of this year,” Outlook Therapeutics CEO Russell Trenary said in a statement.
READ: Outlook Therapeutics opts to resubmit BLA for wet AMD drug after FDA requests more info
“As stated previously, we believe the results from our clinical trials demonstrated safety and efficacy and we are on track to re-submit this BLA and, if approved, to deliver the first FDA-approved ophthalmic formulation of bevacizumab to the retina community,” Trenary added.
Outlook Therapeutics noted, as previously announced, it submitted its BLA for ONS-5010 to the FDA in March 2022 and subsequently, voluntarily withdrew its submission in May 2022 to provide additional information requested by the FDA.
Outlook Therapeutics is working to develop and launch ONS-5010, the clinical-stage company’s treatment for age-related wet macular degeneration and other retinal diseases.
Contact Sean at sean@proactiveinvestors.com