SWITZERLAND – Roche announced that it has received FDA approval for the first-ever bispecific antibody treatment for two common causes of vision loss, paving the way for a battle with Regeneron, which markets a blockbuster drug in this space.

Regeneron has dominated the dual markets for nearly a decade with Eylea, a once-weekly injected antibody.

This dominance has held up well in the face of new challengers. Allergan’s synthetic antibody-like drug showed Phase III results in 2018, but the FDA rejected it due to safety concerns.

Novartis invested heavily in its own next-generation rival Beovu, including a US$130 million priority review voucher, but it has been plagued by safety concerns.

The new drug, faricimab, now marketed as Vabysmo, was approved for use in diabetic macular edema and wet age-related macular degeneration, two of the leading causes of blindness in older Americans.

The approval comes just a week after two studies published in The Lancet found that Vabysmo was safe and effective in improving or maintaining vision in patients with wet age-related macular degeneration and diabetic macular edema, conditions that affect nearly 1.9 million people in the United States and 40 million worldwide.

The antibody drug binds to vascular endothelial growth factor-A and angiopoietin-2 to block signals associated with inflammation and blood vessel leakage, both of which are major issues for patients suffering from these eye diseases.

Recent studies found that the drug performed about as well as Regeneron’s market-leading drug, Eylea.

Faricimab from Genentech, on the other hand, has a clear advantage: unlike Eylea, which is administered at 8-week or 12-week intervals, faricimab can be administered every 16 weeks.

A different mechanism of action contributes to the increased durability. Faricimab is a bispecific antibody.

Faricimab blocks both Vascular endothelial growth factor (VEGF) and another blood vessel growth regulatory protein called angiopoietin-2, whereas Eylea and Beovu only block a receptor called VEGF, a protein that promotes blood vessel growth.

Regeneron, Roche, and Novartis may also face competition from gene therapy developers, such as Regenxbio and its Big Pharma partner AbbVie, who are attempting to develop one-and-done versions of Eylea.

Roche and Genentech are yet to be announce the drug’s price.

Liked this article? Sign up to receive our regular email newsletters, focused on Africa and World’s healthcare industry, directly into your inbox. SUBSCRIBE HERE