ONS-5010 / LYTENAVA™ (bevacizumab-vikg) — Investigational Ophthalmic Formulation of Bevacizumab
ONS-5010 / LYTENAVA™ is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other approved retinal diseases. We currently intend to commercialize ONS-5010 in both vial and pre-filled syringe formulations.
Bevacizumab is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (or mAb) that inhibits VEGF and associated angiogenic activity. With wet AMD, abnormally high levels of VEGF are secreted in the eye. 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 (National Eye Institute).
About AMD and Anti-VEGF Therapy
Wet AMD is the leading cause of vision loss among people age 50 and older*
2.8 million wet AMD patient prevalence**
Anti-VEGF therapy is the global standard of care for wet AMD within the retina community
More than $9 Billion estimated annual 2018 revenue from FDA-approved anti-VEGFs for ophthalmic use (LUCENTIS® and EYLEA®)**
Off-label use of bevacizumab estimated to account for approximately 50% of all wet AMD prescriptions in the United States**
What is AMD?
Age-related macular degeneration, AMD, is a common eye condition and a leading cause of vision loss among people age 50 and older. It causes damage to the macula, a small spot near the center of the retina and the part of the eye needed for sharp, central vision, which lets us see objects that are straight ahead.*
What is "Wet" AMD?
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.*
What is VEGF?
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.*
How established is anti-VEGF Therapy?
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 an over 2.8 million patient prevalence in the United States, top five European countries and Japan in 2016.** In 2018, revenue from FDA-approved anti-VEGFs (LUCENTIS® and EYLEA®) was estimated to exceed $9 billion annually in those ophthalmic markets.**
Although not currently FDA-approved for use in treating wet AMD, off-label use of repackaged intravenous (IV) bevacizumab is believed to account for approximately 50% of all wet AMD prescriptions in the United States.