HCP Live
Contagion LiveCGT LiveNeurology LiveHCP LiveOncology LiveContemporary PediatricsContemporary OBGYNEndocrinology NetworkPractical CardiologyRheumatology Netowrk

Faricimab Receives Approval from US FDA for Diabetic Macular Edema, Wet AMD

Announced on Jan. 31, the approved indication is a first-of-its-kind for a novel therapy—a bispecific antibody injection treatment for the leading causes of blindness.

This article was originally published on HCPLive.com.

The US Food and Drug Administration (FDA) has approved faricimab (Vabysmo) for the treatment of adults with diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD), according to a statement from Roche.

The Biologics License Application (BLA) approval granted to Roche makes the intravitreal bispecific antibody angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A) inhibitor the first of its kind indicated for treating ophthalmic disease. More than that, experts have expressed excitement for the introduction of a new drug class that differs in mechanism and benefit from the standard-of-care anti-vascular endothelial growth factor (VEGF) injections.

“Anti-VEGF monotherapies have been fantastic for our field and for our patients—they really changed a lot of lives and saved a lot of vision,” faricimab investigator Charles C. Wykoff, MD, of the Retina Consultants of Texas, told HCPLive. “But there’s been a hope to move beyond anti-VEGF monotherapy for a long time.”

Faricimab’s approval for patients with nAMD or DME was supported by findings from a pair of pivotal phase 3 trials assessing the agent in either patient population: TENAYA and LUCERNE, and YOSEMITE and RHINE, respectively.

In TENAYA and LUCERNE, faricimab met the primary endpoint of non-inferior visual acuity (VA) gains to aflibercept (EYLEA) in both trials: +5.8 and +6.8 letters versus +5.1 and +6.6, respectively. In YOSEMITE and RHINE, faricimab met the primary endpoint of non-inferior best-corrected VA (BCVA) change over 1 year versus aflibercept in both trials: +11.6 and +10.8 versus +10.9 and +10.3, respectively.

Among all 4 trials, good tolerance was observed with faricimab; investigators observed no new or unexpected adverse events. Wykoff did note to HCPLive® an interest in continuing to observe risk of intraocular inflammation in patients with DME treated with faricimab in the two-plus year follow-up YOSEMITE and RHINE trials, but he believes the association is not clinically meaningful.

Wykoff additionally emphasized the observed long-term benefit of faricimab, which was assessed in varying dose regimen schedules for patients with retina disease. As he explained, a key differentiator with the bispecific antibody therapy versus standard-care anti-VEGF treatment is the frequency by which patients have achieved visual acuity improvement with less frequent doses.

“The reason this trial is important is because it gives an indication of the true durability, potentially, in the real world,” Wykoff said. “That’s why it was exciting when we saw over 50% of patients are achieving every 16 weeks dosing, and more than 75% are achieving every 8-12 weeks dosing.”

Speaking specifically to its benefit in treating DME, Wykoff highlighted faricimab's novel targeting of the Ang-2 pathway—which ultimately helps stabilize retinal vasculature, decrease inflammation, and allow for extended treatment durability in patients, he said.

"There’s a lot of basic science data to indicate that especially diabetic macular edema is a multifactorial disease, as characterized by up-regulation in multiple different cytokine pathways," Wykoff explained. "So it’s exciting to have a new molecule that’s capable of both inhibiting the VEGF-A pathway that we’re well aware of, but now bringing in a new pathway into the story.”