ONS-5010 — Ophthalmic Bevacizumab Formulation
ONS-5010 is a proprietary ophthalmic formulation of bevacizumab to be administered as an intravitreal injection for the treatment of wet AMD and other retina diseases.
Bevacizumab is a full length humanized anti-VEGF (Vascular Endothelial Growth Factor) antibody which inhibits VEGF and associated angiogenic activity. This proprietary ophthalmic bevacizumab product candidate is an anti-VEGF recombinant humanized monoclonal antibody (or mAb) formulated as a single use vial for IVT injection.
By inhibiting the VEGF receptor from binding, bevacizumab prevents the growth and maintenance of tumor blood vessels.
Clinical Progress
The first clinical study for ONS-5010 is being conducted...ONS-5010 Clinical Progress
The first clinical study for ONS-5010 is being conducted outside of the United States and is designed to serve as the first of two adequate and well controlled studies for wet AMD.
The U.S. portion of the second study is scheduled to begin in early 2019 upon the submission of an investigational new drug (IND) application. Outlook Therapeutics’ wet AMD clinical program was reviewed at a successful end of Phase 2 meeting held with the U.S. Food and Drug Administration (FDA) conducted earlier in 2018.
If the program is successful, it will support the Company’s plans to submit for regulatory approval in multiple markets in 2020. The Company is developing ONS-5010 as an innovative therapy and not using the biosimilar drug development pathway.
Previously, ONS-5010 met the primary and secondary endpoints in a 3-arm single-dose pharmacokinetic (PK) Phase 1 clinical trial. All of the PK endpoints met the bioequivalency criteria of the geometric mean ratios within 90% confidence interval of 80-125% when compared to both U.S.- and EU-sourced Avastin® reference products.
About AMD and wet AMD
Age related macular degeneration is a common eye condition...ABOUT AMD
Age related macular degeneration, AMD, is a common eye condition and a leading cause of vision loss among people age 50 and older. Wet AMD is a form of “late stage” AMD, and is also called neovascular AMD.
In wet AMD, abnormal blood vessels grow underneath the retina. These vessels can leak fluid and blood, which may lead to swelling and damage of the macula causing vision loss.
With wet AMD, abnormally high levels of vascular endothelial growth factor (VEGF) are secreted in the eyes. VEGF is a protein that promotes the growth of new abnormal blood vessels. Anti-VEGF injection therapy blocks this growth.
Since the advent of anti-VEGF therapy, it has become the standard of care treatment option within the retina community, globally.
Wet AMD is a significant disease worldwide, with over 1.8 million patients diagnosed in the United States, top five European countries and Japan alone in 2016 (GlobalData). Revenue from anti-VEGFs (Avastin™, Lucentis™, Eylea™ and Macugen™) exceeded $8 billion annually in those ophthalmic markets in 2016 (GlobalData). Although not currently FDA-approved for use in treating wet AMD, it is believed that bevacizumab accounts for approximately 50% of all wet AMD prescriptions in the United States.