Roche Reports the US FDA’s Acceptance of BLA for Faricimab to Treat Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration

Shots:

• The BLA submission is based on four P-III studies i.e TENAYA, LUCERNE, YOSEMITE & RHINE evaluating the efficacy & safety of faricimab vs aflibercept in patients with nAMD & DME. The LTE studies for faricimab are underway
• The studies demonstrated non-inferior visual acuity gains and greater reductions in CST, ~50% of patients can extend treatment time to every 4mos. in the 1st yr. in nAMD & DME studies. The therapy was well tolerated with no new safety signals identified
• If approved, Faricimab will be the first bispecific Ab designed to target two pathways i.e., Ang-2 and VEGF-A for retinal disorders. The EMA has also validated the MAA of faricimab for nAMD & DME

Click here to­ read full press release/ article | Ref: GlobeNewswire | Image: Spain’s News