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. Outlook Therapeutics submitted a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for ONS-5010 to treat wet AMD on March 30, 2022. After conversations with the FDA about its filing, the Company has voluntarily withdrawn the BLA as it works to provide supplemental information that the FDA has requested. Outlook Therapeutics remains in active discussions with the FDA and expects to resubmit the BLA by September 2022. 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 and Ajinomoto Biopharma Services to provide product manufacturing in their best-in-class cGMP global manufacturing facilities.
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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