Roche's Eylea rival poised for FDA filings with new phase 3 data

Roche’s bispecific antibody matched Regeneron’s blockbuster Eylea in four phase 3 studies comparing the two in diabetic macular edema (DME) and wet age-related macular degeneration (AMD). The studies found the experimental drug did no worse than the incumbent despite a majority of the patients taking it going longer between injections.

The company pitted the bispecific antibody faricimab, which targets VEGF and Ang2, against Eylea in two studies each involving more than 900 patients with DME and two studies with more than 600 patients each who had wet AMD. All four studies met their primary endpoint, with faricimab matching Eylea at improving vision after one year as measured by Best Corrected Visual Acuity (BCVA), or the best vision a person can achieve wearing glasses or contact lenses. Investigators assessed BCVA using a standard vision testing tool featuring rows of progressively smaller letters.

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But that’s not all—about half of the patients across all four trials could go four months between doses of faricimab, compared to the two-month dosing schedule for Eylea. That’s an important distinction for patients whose treatment is injected into the eye.

“Faricimab’s potential to extend time between treatments may benefit those patients who struggle to keep up with the regular physician visits and eye injections needed to preserve their vision,” said Jeffrey Heier, M.D., director of retinal research at Ophthalmic Consultants of Boston, in a statement.

The DME trials tested faricimab in two patient groups: those who received it every two months or those with personalized treatment intervals of every one, two, three or four months. The wet AMD trials dosed patients every two, three or four months, depending on their disease activity.

About half of the DME patients and about 45% of the wet AMD patients could be treated with faricimab every four months, while about one-fifth of DME patients and one-third of the wet AMD patients could be dosed every three months. Their vision improvement was on par with that seen in the Eylea groups, Roche said. However, the company did not separate figures for individual dosing regimens, so the vision improvement seen in the studies also include results from patients being treated at shorter intervals.

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Roche will present results from the studies Saturday at Angiogenesis, Exudation, and Degeneration 2021, a medical symposium presented by Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine. It will submit results from all four studies to health authorities around the world, including the U.S. and EU, for approvals in DME and wet AMD.

Despite the promise faricimab showed at longer treatment intervals, it is unclear whether that will be enough to turn it into a major product. One issue for Roche is faricimab will likely need to compete with Eylea and biosimilar copies. Mylan, Samsung Bioepis and Amgen are among the companies with copies of Eylea in development. Filings for FDA approval could start this year, led by Mylan.

Editor's note: This story has been updated to clarify dosing details of the faricimab studies.