FDA Accepts Genentech’s Application for Bispecific Antibody to Treat Eye Diseases

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FDA has accepted Genetech’s BLA for faricimab, a bispecific antibody in development for treating wet age-related macular degeneration and diabetic macular edema.

Genentech, a member of the Roche Group, announced that FDA has accepted its biologics license application (BLA) with priority review for faricimab, a bispecific antibody for treating wet age-related macular degeneration (AMD) and diabetic macular edema (DME). The company also said that FDA has accepted its submission of the drug for treating diabetic retinopathy, according to a July 28, 2021 press release.

Faricimab targets two pathways—angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). These two pathways drive a number of retinal conditions that can cause vision loss. Ang-2 and VEGF-A contribute to vision loss because they destabilize blood vessels, which causes the vessels to leak and causes inflammation. Faricimab simultaneously blocks both the Ang-2 and VEGF-A pathways, thus stabilizing blood vessels and potentially improving vision.

Genentech’s BLA submission is based on positive results from four Phase III studies in wet AMD and DME, which consistently showed that faricimab offered vision gains comparable to that of aflibercept; faricimab was given at intervals of up to four months and aflibercept was given every two months. The studies also showed that approximately three-quarters of people who were eligible to receive extended doses of faricimab were able to be treated every three months or longer within the first year. Genentech is additionally conducting long-term extension studies for faricimab in wet AMD and DME. Faricimab has been granted marketing authorization in Europe by the European Medicines Agency for treating wet AMD and DME.


“If approved [by FDA], faricimab would be the first in a new class of eye medicines targeting two key pathways that drive retinal disorders, with the potential to offer durable vision outcomes with fewer eye injections than the current standard of care,” said Levi Garraway, chief medical officer and head of Global Product Development, Genentech, in a company press release. “Therefore, we hope faricimab will become a new treatment option for millions of people living with wet AMD and DME.”

Source: Genentech