Outlook Therapeutics is focused on developing and commercializing a commercially attractive monoclonal antibody for various ophthalmic indications
Outlook Therapeutics confirms BLA re-submission date for its ONS-5010 wet AMD treatment
Outlook Therapeutics submits BLA to FDA for its investigational therapy to treat wet AMD
About the company
Outlook Therapeutics Inc is a late clinical-stage biopharmaceutical company focused on developing and commercializing ONS-5010, a complex, technically challenging and commercially attractive monoclonal antibody, or mAb, for various ophthalmic indications. Its goal is to launch ONS-5010 as the first, and only, approved bevacizumab in the United States, Europe, Japan and other markets for the treatment of wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and branch retinal vein occlusion (BRVO).
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.
“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Outlook Therapeutics (NASDAQ:OTLK) Inc said it has voluntarily withdrawn the biologics license application (BLA) for its ophthalmic formulation of bevacizumab (ONS-5010 or Lytenava) after the US Food and Drug Administration (FDA) requested additional information.
The company added that it is actively working to respond to the FDA’s request and plans to resubmit a revised BLA by September. A BLA is a request to introduce, or deliver for introduction, a biological product into interstate commerce.
Outlook Therapeutics (NASDAQ:OTLK) Inc ended its fiscal second quarter with $58.4 million in cash – enough to launch its lead drug ONS-5010 without raising significant additional capital, it said.
ONS-5010, which will be sold under the brand name Lytenava, is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet age-related macular degeneration (AMD) and other retinal diseases.
Outlook Therapeutics (NASDAQ:OTLK) Inc CEO Russ Trenary tells Proactive it has submitted its Biologics License Application to the FDA for ONS-5010, an investigational therapy for the treatment of wet age-related macular degeneration (wet AMD).
If approved, the treatment will be branded as LYTENAVA (bevacizumab-vikg) and could replace the current practice of using unapproved repackaged IV bevacizumab sourced from compounding pharmacies, products that have known risks of contamination and inconsistent potency and availability.
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