Faricimab Treat-and-Extend Dosing for Macular Edema Due to Retinal Vein Occlusion
Year: 2025
Type: article
Abstract: PURPOSE: To assess the efficacy, durability, and safety of dual angiopoietin-2/VEGF inhibition with faricimab dosed per a modified treat-and-extend-based regimen in patients with retinal vein occlusion. DESIGN: Single-arm treatment period after a randomized, double-masked, active comparator-controlled period in the phase III BALATON/COMINO (NCT04740905/NCT04740931) trials. PARTICIPANTS: Patients with treatment-naïve foveal center-involved macular edema due to branch (BALATON; N = 553) or central/hemiretinal (COMINO; N = 729) retinal vein occlusion. METHODS: Patients randomized to faricimab 6.0 mg every 4 weeks (Q4W) or aflibercept 2.0 mg Q4W up to week 20 received faricimab 6.0 mg dosed per a modified treat-and-extend-based regimen from week 24 to 72. The dosing frequency was adjusted from Q4W to Q16W based on changes in central subfield thickness (CST) and best-corrected visual acuity. MAIN OUTCOME MEASURES: Change from baseline through week 72 in best-corrected visual acuity and CST; durability and safety through week 72. RESULTS: Visual acuity gains and CST reductions achieved at week 24 were maintained through week 72. Adjusted mean best-corrected visual acuity (95.03% confidence interval [CI]) changes from baseline averaged over weeks 64, 68, and 72 in the prior faricimab Q4W and prior aflibercept Q4W arms were +18.1 letters (16.9-19.4) and +18.8 letters (17.5-20.0), respectively, in BALATON and +16.9 letters (15.2-18.6) and +17.1 letters (15.4-18.8), respectively, in COMINO. Adjusted mean (95.03% CI) CST changes from baseline averaged over weeks 64, 68, and 72 in the prior faricimab Q4W and prior aflibercept Q4W arms were -310.9 μm (-315.6 to -306.3) and -307.0 μm (-311.7 to -302.3), respectively, in BALATON and -465.9 μm (-472.5 to -459.3) and -460.6 μm (-467.2 to -453.9), respectively, in COMINO. In the prior faricimab Q4W and prior aflibercept Q4W arms, 64.1% and 56.9% of patients from BALATON and 45.5% and 50.1% from COMINO, respectively, were on ≥Q12W dosing at week 68. Faricimab continued to be well tolerated from weeks 24 to 72; the safety profile was consistent with that established for diabetic macular edema and neovascular age-related macular degeneration. CONCLUSIONS: These findings support the sustained efficacy and safety of faricimab in patients with macular edema due to retinal vein occlusion up to 72 weeks, with the potential for reduced treatment burden due to response durability. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Source: Ophthalmology Retina
Authors: Carl J. Danzig, Christiana Dinah, Faruque Ghanchi, Lars-Olof Hattenbach, Arshad M. Khanani, Timothy Y.Y. Lai, Masahiko Shimura, Francis Abreu, Pablo Arrisi, Ying Liu, Liliana P. Paris, Anne-Cecile Retiere, Jeffrey R. Willis, Patricio G. Schlottmann, Ashkan Abbey, Elmira Abdulaeva, Santiago Abengoechea, Prema Abraham, Sean Adrean, Hansjürgen Agostini, Arturo Alezzandrini, Daniel Alfaro, Socorro Alforja, Daniel Aliseda, Goncalo Almeida, Payam Amini, Liangbao An, Etelka Aradi, Luis Arias, Sergei Astakhov, Carl Awh, Bulat Aznabaev, Joaquin Bafalluy, Chandra Balaratnasingam, Francesco Bandello, Sanjiv Banerjee, Mark Barakat, Andres Bastien, Ivan Batlle, Rubens Belfort, Brian Berger, Emilia Borcz, Arnaldo Bordon, Michael Briggs, Harold Brooks, David Brown, Jamin Brown, Jacek Brymerski, Maria Budzinskaya, Stuart Burgess, Iksoo Byon, Peter Campochiaro, Andrew Chang, Emmanuel Chang, Caroline Chee, Changzheng Chen, Judy Chen, Shih-Jen Chen, Nicholas Chinskey, Oldrich Chrapek, Salomon Yves Cohen, Juner Colina-Biscotto, Brian Connolly, Pierre Loic Cornut, Hajir Dadgostar, Hong Dai, Carl Danzig, Anthony de Beus, Mario R. del Cid, Amr Dessouki, Christiana Dinah, Antonio Donate, David Eichenbaum, Jan Ernest, Joan Josep Escobar, Andrej Farkas, Nicolas Feltgen, Gloria Ferguson, Philip Ferrone, Joao Figueira, Marta Figueroa, Pablo Franco, Samantha Fraser-Bell, Nicholas Siu Kay Fung, Roberto Gallego-PInazo, Alfredo Garcia-Layana, Maciej Gawecki, Nicola Gan, Faruque Ghanchi, Ghassan Ghorayeb, Fabrizio Giansanti, Manjot Gill, Michaella Goldstein, Fumi Gomi, Jordan Graff, Shailesh Gupta, Mei Han, Ryuya Hashimoto, Lars-Olof Hattenbach, Ken Hayashi, Lina Kobayter Helayhel, Ewa Herba, Vrinda Hershberger, Patrick Higgins, Takao Hirano, Yoshio Hirano, Shigeru Honda, Allen Hu, Stephen Huddleston, Alan A. Hunter, Yih-Shiou Hwang, Tomohiro Iida, Yuichiro Ishida, Golnaz Javey, Cameron Javid, Jakub Kaluzny, Hiroki Kaneko, Se Woong Kang, Hakan Kaymak, Patrick Kelty, Agnes Kerenyi, Arshad Khanani, Rahul Khurana, Jong Woo Kim, Sang Jin Kim, Genichiro Kishino, Namie Kobayashi, Lina Kobayter Helayhel, Bohdan Kousal, Robert Kwun, Alexey Kulikov, Ajay Kuriyan, James Lai, Yuk Yau Timothy Lai, Wai Ching Lam, Daniel Lavinsky, Seong Lee, Xiaorong Li, Xiaoling Liang, Lucas Lindsell, Nikolas London, Peck-Lin Lip, Mimi Liu, Xiaoling Liu, Alan Luckie, Miguel Lume, James K. Luu, Dennis Marcus, Yoshitsugu Matsui, Hemal Mehta, Katarzyna Michalska-Malecka, Yoshinori Mitamura, Quresh Mohamed, Aditi Mohla, Javier Montero, Jeffrey Moore, Ryusaburo Mori, Haia Morori-Katz, Raj Mukherjee, Yuki Muraoka, Maria Muzyka-Wozniak, Jan Nemcansky, Tetsuya Nishimura, Hideyasu Oh, Piotr Oleksy, Kyu Hyung Park, D. Wilkin Parke, Maria Cristina Parravano, Apurva Patel, Sunil Patel, Marc Peden, Fernando Penha, Qing Peng, Nadezhda Pozdeyeva, Dorota Raczynska, Hessam Razavi, Gayatri Reilly, Marek Rekas, Federico Ricci, Richard Roe, Soraya Rofagha, Bozena Romanowska-Dixon, Irit Rosenblatt, Jose Maria Ruiz Moreno, Stefan Sacu, Min Sagong, Yoshitsugu Saishin, Taiji Sakamoto, Sukhpal Sandhu, Laura Sararols, Mario Saravia, Patricio Schlottmann, Tetsuju Sekiryu, András Seres, Ankur Shah, Veeral Sheth, Masahiko Shimura, Bartosz Sikorski, Rufino Silva, Zongming Song, Eric Souied, Robert Stoltz, Guanfang Su, Iichiro Sugita, Dawei Sun, Guangli Sun, Zuhua Sun, Kiyoshi Suzuma, Ramin Tadayoni, Alexandre Taleb, James Talks, Anna Tan, Liran Tiosano, Edit Toth-Molnar, Attila Vajas, Balazs Varsanyi, Sara Vaz-Pereira, Miroslav Veith, Jose Ignacio Vela, Francesco Viola, Sanjeewa Wickremasinghe, Martin Weger, Aaron Weinberg, John Wells, Michael Williams, Andre Witkin, Piotr Wnorowski, Jeremy Wolfe, James Wong, Robert Wong, Se Joon Woo, Bogumil Wowra, Jian-Sheng Wu, Wei-Chi Wu, Charles Wykoff, Edward Wylęgała, Xun Xu, Chang-Hao Yang, Ke Yao, Yoshihiro Yonekawa, Young Hee Yoon, Barak Yoreh, Shigeo Yoshida, Takafumi Yoshioka, Seung Young Yu, Tatiana Yurieva, Karolina Zaczek Zakrzewska, Alberto Zambrano, Malgorzata Zaras, Barbara Zatorska, Carlos Zeolite, Ming Zhang
Institutions: Florida Atlantic University, London North West Healthcare NHS Trust, Central Middlesex Hospital, Imperial College London, Bradford Teaching Hospitals NHS Foundation Trust, Klinikum Ludwigshafen, University of Nevada, Reno, Sierra Eye Associates, Chinese University of Hong Kong, Tokyo Medical University Hachioji Medical Center, Roche (United Kingdom), Genentech
Language: English
Subfield: Ophthalmology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,920
Funder: F. Hoffmann-La Roche
OpenAlex ID: W4408514340