We are advancing ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet AMD, DME and BRVO.
Outlook Therapeutics is a pre-commercial biopharmaceutical company working to develop and launch ONS-5010 / LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. The U.S. Food and Drug Administration, which had accepted Outlook Therapeutics’ Biologics License Application (BLA) for ONS-5010 to treat wet AMD on October 27, 2022, issued a Complete Response Letter (CRL) on the Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023. While the FDA acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, the Agency concluded it could not approve the BLA during this review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence. Outlook Therapeutics is working closely with the FDA to address the Agency’s concerns so that the BLA can be re-submitted for approval. The Company will request a Type A meeting as soon as possible to discuss the CRL and determine potential paths forward for the approval of ONS-5010 for the treatment of wet AMD.
If ONS-5010 is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan, Greater China and other markets. Outlook Therapeutics’ BLA submission for ONS-5010 is as a new BLA under the PHSA 351(a) regulatory pathway.
If ONS-5010 is approved, the Company expects to commercialize it through best-in-class partnerships. To date, Outlook Therapeutics has manufacturing partnerships with Fujifilm Diosynth Biotechnologies for drug product and Ajinomoto Biopharma Services for finished product manufacturing in their best-in-class cGMP global manufacturing facilities. As part of the Company’s multi-year commercial planning process and in anticipation of potential FDA approval, Outlook Therapeutics and Cencora (previously AmerisourceBergen) entered into a strategic commercialization agreement to expand the Company’s reach for connecting to retina specialists and their patients. Cencora will provide third-party logistics (3PL) services and distribution, as well as pharmacovigilance and other services in the United States.
Outlook Therapeutics has also executed a supply agreement for a best-in-class pre-filled ophthalmic syringe that will provide both ease-of-use for clinicians and add to ONS-5010’s potential safety profile over the current unapproved therapies that have caused problems related to syringe malfunction, contamination, etc.
Outlook Therapeutics intends to create goodwill and acceptance among payors, retinal specialists and patients by offering excellent value in an FDA-approved ONS-5010.
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