The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for faricimab for the treatment of wet, or neovascular, age-related macular degeneration and diabetic macular edema.
Faricimab is an investigational bispecific antibody that targets the angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) pathways. Blocking both pathways is expected to stabilize blood vessels and potentially improve vision outcomes in patients with retinal conditions.
The BLA is supported by data from two phase 3 trials in patients with wet age-related macular degeneration (TENAYA [ClinicalTrials.gov Identifier: NCT03823287] and LUCERNE [ClinicalTrials.gov Identifier: NCT03823300]) and two phase 3 trials involving patients with diabetic macular edema (YOSEMITE [ClinicalTrials.gov Identifier: NCT03622580] and RHINE [ClinicalTrials.gov Identifier: NCT03622593]).
In the TENAYA and LUCERNE trials (N=1329), faricimab met the primary endpoint demonstrating noninferior visual acuity gains of +5.8 and +6.6 eye chart letters, respectively, compared with aflibercept (+5.1 and +6.6 letters, respectively).
In the YOSEMITE study (n=940), the average vision gains were +11.6 and +10.7 letters in the faricimab personalized treatment interval (PTI; up to 4 months) arm and the fixed 2-month interval arm, respectively, compared with +10.9 letters in the aflibercept arm. The RHINE study (N=951), which had an identical design, showed average vision gains of +10.8 and +11.8 letters in the faricimab PTI and 2-month arms, respectively, and +10.3 letters in the aflibercept arm.
“If approved, faricimab would be the first in a new class of eye medicines targeting 2 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, MD, PhD, chief medical officer and head of Global Product Development.
FDA accepts application for Genentech’s faricimab for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Accessed July 29, 2021. https://www.businesswire.com/news/home/20210728006055/en/FDA-Accepts-Application-for-Genentech%E2%80%99s-Faricimab-for-the-Treatment-of-Wet-Age-Related-Macular-Degeneration-AMD-and-Diabetic-Macular-Edema-DME