This article is part of MPR’s coverage of the American Academy of Ophthalmology 2019 Meeting, taking place in San Francisco, CA. Our staff will report on medical research related to eye disorders, conducted by experts in the field. Check back regularly for more news from AAO 2019.
SAN FRANCISCO – Faricimab showed sustained anatomic and visual outcomes at extended dosing intervals (every 16 or 12 weeks) compared with ranibizumab dosed every 4 weeks for neovascular age-related macular degeneration (nAMD), according to data from the phase 2 STAIRWAY trial presented at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting, held October 12-15, 2019 in San Francisco, California.
The 52-week, randomized, multicenter, active comparator-controlled trial evaluated the efficacy, safety and pharmacokinetics of faricimab administered via intravitreal (IVT) injection with extended dosing regimens in treatment-naive patients with nAMD. Patients were randomized 2:2:1 to faricimab 6mg IVT every 16 weeks flex or every 12 weeks fixed (both with every 4 weeks initiation) or ranibizumab 0.5mg IVT every 4 weeks. Key anatomic end points included change from baseline in total lesion area, change from baseline in choroidal neovascularization (CNV) component area, and change from baseline in leakage area.
Results from the 3 treatment arms (faricimab every 16 weeks flex, faricimab every 12 weeks fixed, and ranibizumab every 4 weeks) at week 52 demonstrated a change from baseline in total lesion area of -4.2, -5.4, and -4.5mm2, respectively; change from baseline in CNV component area of -4.3, -5.6, and -4.8mm2; change from baseline in leakage area of -4.6, -5.6, and -5.3mm2, respectively. Patients treated with faricimab also maintained vision with approximately half as many injections compared with ranibizumab. Regarding safety, faricimab was found to be well-tolerated; no new safety signals were identified in the trial.
Faricimab (RG7716; Roche) is a bispecific antibody designed to simultaneously bind to both angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A) with high potency and specificity, thus preventing blood vessel permeability, abnormal blood vessel growth and fluid leakage that typically lead to nAMD.
Eichenbaum DA, et al. Additional Anatomic Endpoints Support Sustained Outcomes With Faricimab Every 16 Weeks in the STAIRWAY Phase 2 Trial for nAMD. Poster number: PO450. The American Academy of Ophthalmology Meeting; October 12-15 2019.