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Outlook Therapeutics Confirms Status of Biologics License Application (BLA) Submission for ONS-5010
Outlook Therapeutics reiterates expected re-submission of BLA by September 2022 following receipt of additional correspondence from U.S. Food and Drug
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"Outlook Therapeutics reiterates expected re-submission of BLA by September 2022 following receipt of additional correspondence from U.S. Food and Drug Administration (FDA) ISELIN, N.J., June 14, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, is providing 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). As previously announced, Outlook Therapeutics 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. Following receipt of further correspondence from the FDA, Outlook Therapeutics has confirmed the additional information necessary to re-submit the BLA for ONS-5010. C. Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, commented, “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. 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.” About ONS-5010 / LYTENAVA™ (bevacizumab-vikg) 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. Because no currently approved ophthalmic formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab must use unapproved repackaged IV bevacizumab provided by compounding pharmacies, products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 can replace the need to use unapproved repackaged IV bevacizumab from compounding pharmacies for the treatment of wet AMD. Bevacizumab-vikg is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endotheli...