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 late clinical-stage 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. 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 expects to submit ONS-5010 with the U.S. FDA as a new BLA under the PHSA 351(a) regulatory pathway during the first calendar quarter of 2022.

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 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.

Learn more about ONS-5010 / LYTENAVA™ (bevacizumab-vikg) >

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