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

 Ref: GlobeNewswire | Image: Roche