Outlook Therapeutics announced that the FDA has accepted for filing a Biologics License Application (BLA) for ONS-5010/Lytenava (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (AMD).
The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023. ONS-5010, if approved, is expected to receive 12 years of regulatory exclusivity in the United States.
“This BLA acceptance and PDUFA date are significant milestones in our mission to offer clinicians and their patients the first and only on-label, ophthalmic bevacizumab to treat wet AMD,” Russell Trenary, President and CEO of Outlook Therapeutics, said in a company news release.
“If approved, ONS-5010 (bevacizumab-vikg) will meet the robust FDA requirements for use as an ophthalmic injectable. We estimate that approximately 50% of the millions of anti-VEGF injections in ophthalmology are off-label compounded bevacizumab that is administered with no FDA-approved labeling. That product configuration does not meet the same standards we must achieve to earn FDA approval in ophthalmology.”
Outlook Therapeutics and AmerisourceBergen recently announced a strategic commercialization agreement to broaden the company's reach for establishing connections with retina specialists and their patients. The agreement is a part of the company's multi-year commercial planning process and is expected to be approved by the FDA in August 2023.
AmerisourceBergen will offer distribution, third-party logistics (3PL), and pharmacovigilance services in the United States. By means of this arrangement, Outlook Therapeutics hopes to expand the market reach and effective distribution of ONS-5010 while avoiding any duplication of AmerisourceBergen's services and cutting down on Outlook's otherwise necessary expenditure for those same services.
In addition, Outlook Therapeutics formed partnerships with FUJIFILM Diosynth Biotechnologies for the production of drug substances and with Ajinomoto Bio-Pharma Services for the production of completed pharmaceuticals.
In addition to the U.S. filing, Outlook Therapeutics is also developing registration documents on a parallel path for approvals in Europe and expects to submit them in the fourth quarter of 2022. Outlook Therapeutics is examining country-by-country the viability of direct commercialization and joint ventures in Europe and Asia.