Author:
Penha Fernando M,Masud Maliha,Khanani Zoha A.,Thomas Mathew,Fong Rodney D.,Smith Kyler,Chand Avishay,Khan Majid,Gahn Greggory,Melo Gustavo Barreto,Khanani Arshad M.
Abstract
AbstractManagement of vitreoretinal disorders (e.g., neovascular age-related macular degeneration [nAMD] and diabetic macular edema [DME]) have assumed the standard therapy of lifelong anti-VEGF injections with drugs like aflibercept, brolucizumab, ranibizumab and bevacizumab. However, the burden imposed on patients is a major deterrent for continual therapy and recovery. Faricimab, a bispecific antibody, blocking both VEGF-A and Ang-2 molecules, produces a comparable functional and anatomical results, with less injections, significantly reducing patient burden. Visual acuity, safety, adverse effects, and anatomical outcomes are discussed in the pivotal clinical trials (YOSEMITE/RHINE and TENAYA/LUCERNE), and early data from real-world studies (TRUCKEE, TAHOE, FARWIDE-DME, FARETINA and others). In YOSEMITE and RHINE, faricimab demonstrated non-inferior vision gains, better anatomical outcomes compared to aflibercept every 8 weeks. Faricimab in the personalized treatment interval (PTI), after week 96, achieved 12-week interval in 78.1% of the patients and 16-week interval in 62.3%. TENAYA and LUCERNE reported comparable best corrected visual acuity (BCVA) improvement and better anatomic outcomes during head-to-head phase, parallel to aflibercept, at its 8-week treatment schedule. Faricimab in the PTI regimen, after week 96 achieved 12-week interval in 77.8% of the patients and 16-week interval in 63.1%. Safety of faricimab has been comparable to aflibercept in these pivotal trials. Real-world data supports the data from the pivotal studies regarding the efficacy and safety profile of faricimab in heterogenous real world patient population. Moreover, in previously treated patients, it also demonstrated a faster fluid resolution, good safety profile. Considering faricimab has demonstrated anatomic and durability benefit in the treatment of nAMD and DME, additional data from ongoing extension clinical trials, AVONELLE-X and RHONE-X will help understand longer term outcomes for patients treated with faricimab as well as patients switching from aflibercept to faricimab after finishing the pivotal trials. Longer term data from the real-world studies will also continue to contribute to our understanding of long-term efficacy, safety and durability in the real world patient population.
Publisher
Springer Science and Business Media LLC
Reference33 articles.
1. Shirley M, Faricimab. First Approval Drugs. 2022;82(7):825–30.
2. Samanta A, Aziz AA, Jhingan M, Singh SR, Khanani AM, Chhablani J. Emerging therapies in Nonexudative Age-Related Macular Degeneration in 2020. Asia-Pacific J Ophthalmol. 2021;10(4):408–16.
3. Regula JT, Lundh von Leithner P, Foxton R, Barathi VA, Cheung CMG, Bo Tun SB, et al. Targeting key angiogenic pathways with a bispecific Cross MAb optimized for neovascular eye diseases. EMBO Mol Med. 2016;8(11):1265–88.
4. Imhof BA, Aurrand-Lions M. Angiogenesis and inflammation face off. Nat Med. 2006;12(2):171–2.
5. Genetech. FDA Approves Genentech’s Vabysmo, the First Bispecific Antibody for the Eye, to Treat Two Leading Causes of Vision Loss. 2022.