Additional information requested for BLA for ONS-5010, Outlook to resubmit by September

Outlook Therapeutics Inc. today announced that the FDA has requested additional information in order to complete the filing of the company’s Biologics License Application (BLA) for ONS-5010 (Lytenava) for the treatment of wet age-related macular degeneration (wet AMD).

According to the news release, Outlook Therapeutics has voluntarily withdrawn its BLA for ONS-5010 and is actively working to respond to the FDA’s request. The company plans to re-submit a revised BLA by September 2022.

According to Russell Trenary, president and CEO of Outlook Therapeutics, the company remains confident in “ONS-5010 and its potential to be the first FDA-approved ophthalmic formulation of bevacizumab that avoids the public health risk to patients of off-label treatment of bevacizumab that was never approved for any ophthalmic indications.”

“We are continuing to have productive discussions with the FDA and are committed to providing the additional information necessary to support the application,” he said in a statement. “We look forward to a successful resubmission and ultimately the potential approval of ONS-5010 for the treatment of wet AMD. We also look forward to a future where virtually all retina patients treated with bevacizumab are receiving an FDA-approved ophthalmic therapy.”

According to the company, based on a compilation of the data from previously completed clinical trials – NORSE 1, NORSE 2 and NORSE 3 – Outlook Therapeutics submitted the BLA to the FDA in March.

NORSE 1, a proof-of-concept and clinical experience trial, helped validate the protocols and approach for NORSE 2, the pivotal safety and efficacy trial. The NORSE 2 data were statistically significant and clinically relevant for the primary and all secondary endpoints. NORSE 3 was an open-label supplementary safety trial conducted to ensure that a sufficient number of patients had been dosed with ONS-5010 ophthalmic bevacizumab to support the regulatory submission.

ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Bevacizumab-vikg is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells.