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.

About AMD and anti-VEGF Therapy

AMD is the leading cause of vision loss among people age 50 and older.

1.8 million AMD patients diagnosed*

Anti-VEGF therapy is the global standard of care for AMD within the retina community

More than $9 Billion estimated annual 2018 revenue from anit-VEGFs for ophthalmic use (Avastin™, Lucentis™, Eylea™ and Macugen™)*

*United States, top five European countries and Japan (Source: GlobalData 2016)

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 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™) is estimated to exceed $9 billion annually in those ophthalmic markets in 2018 (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.