Outlook Therapeutics® Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Retinal Diseases
Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023
ISELIN, N.J., Oct. 28, 2022 (GLOBE NEWSWIRE) — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for ONS-5010 as a potential treatment for retinal diseases.
ONS-5010 is a formulation of bevacizumab, a well-known anti-vascular endothelial growth factor (anti-VEGF) therapy that is used off-label to treat retinal diseases such as wet age-related macular degeneration (wet AMD). Outlook Therapeutics’ ophthalmic formulation aims to provide a safe and effective alternative to the off-label use of intravitreal injections of bevacizumab.
What does this mean for patients?
For patients with retinal diseases, the acceptance of the BLA for ONS-5010 by the FDA represents a significant step towards potentially having a new treatment option available. If approved, ONS-5010 could offer patients a FDA-approved alternative to off-label bevacizumab injections, potentially improving accessibility and safety for those in need of treatment for retinal diseases.
What does this mean for the world?
On a larger scale, the acceptance of Outlook Therapeutics’ BLA for ONS-5010 by the FDA could have broader implications for the ophthalmic and pharmaceutical industries. If approved, ONS-5010 could pave the way for more innovation in the development of ophthalmic formulations and expand treatment options for patients with retinal diseases worldwide.
Conclusion
In conclusion, the acceptance of Outlook Therapeutics’ Biologics License Application for ONS-5010 by the FDA marks a significant milestone in the potential treatment of retinal diseases. Patients may soon have access to a new FDA-approved option, while the industry may see increased innovation and expanded treatment choices. The future looks promising for those affected by retinal diseases, as advancements in ophthalmic formulations continue to evolve.
