On February 9, 2024 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve U.S. Food and Drug Administration (FDA) approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, reported recent corporate highlights and financial results for its fiscal year ended September 30, 2023 (Press release, Outlook Therapeutics, FEB 9, 2024, View Source [SID1234639957]).
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"We remain committed to working with the FDA to design and undertake the additional clinical study for ONS-5010 that, if successful, will satisfy the FDA’s requirements for approval," commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics. "The patient need for an ophthalmic approved bevacizumab remains and we are steadfast in our mission to meet this need."
Upcoming Anticipated Milestones
· FDA response on NORSE EIGHT Special Protocol Assessment (SPA) in early February 2024;
· Commencement of NORSE EIGHT expected in first calendar quarter of 2024;
· MAA decision date in the EU for ONS-5010 expected targeted for first half of 2024;
· Completion of NORSE EIGHT in the U.S. anticipated in 2024; and
· Resubmission of the ONS-5010 BLA expected by the end of calendar year 2024.
ONS-5010 / LYTENAVA (bevacizumab-vikg) Regulatory Update
As previously announced, following a Type A meeting with the FDA held in October 2023, the FDA informed Outlook Therapeutics that it can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment naïve patients with a primary efficacy endpoint at 2 months. Subsequently, as discussed with and recommended by the FDA, Outlook Therapeutics submitted a clinical trial protocol and requested a Type A meeting with the FDA for feedback. The FDA has already provided written feedback on the protocol, which Outlook Therapeutics has incorporated. The revised protocol is the subject of the SPA request, in which Outlook Therapeutics is seeking further confirmation from the FDA that NORSE EIGHT, if successful, addresses the FDA’s requirement for a second adequate and well-controlled clinical trial to support the resubmission of the ONS-5010 BLA for wet AMD. The FDA is expected to provide a response to the SPA by early February 2024.
NORSE EIGHT will be a randomized, controlled, parallel-group, masked study of neovascular age-related macular degeneration subjects randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects will receive injections at Day 0 (randomization), Week 4, and Week 8 visits. Approximately 400 patients are expected to be enrolled in the study.
Additionally, the Company previously announced that it submitted an MAA in Europe, which was validated for review in December 2022. The formal review process of the MAA by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) is underway with an estimated decision date expected in the first half of 2024. In addition to pursuing potential strategic partnering opportunities in the EU and other regions, such as the current partnership with Syntone Biopharma JV in China, Outlook Therapeutics is also exploring potential expanded relationships with Cencora (formerly AmerisourceBergen) to support the launch of ONS-5010 in international markets.
If approved, ONS-5010 / LYTENAVA (bevacizumab-vikg) will be the first FDA approved ophthalmic formulation of bevacizumab.
Financial Highlights for the 2023 Fiscal Year Ended September 30, 2023
For the fiscal year ended September 30, 2023, Outlook Therapeutics reported a net loss attributable to common stockholders of $59.0 million, or $0.24 per basic and diluted share, compared to a net loss attributable to common stockholders of $66.1 million, or $0.31 per basic and diluted share, for the prior fiscal year.
As of September 30, 2023, Outlook Therapeutics had cash and cash equivalents of $23.4 million. On December 21, 2023, Outlook Therapeutics reached an agreement with the holder of its outstanding convertible promissory note to extend the maturity until April 1, 2024.
About ONS-5010 / LYTENAVA (bevacizumab-vikg)
ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Because no FDA-approved ophthalmic formulations of bevacizumab are available currently, clinicians wishing to treat retinal patients with bevacizumab have had to 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 would provide an FDA-approved option for physicians that currently prescribe unapproved repackaged oncologic 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 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. Following intravitreal injection, the binding of bevacizumab-vikg to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.