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Efficacy of Faricimab versus Aflibercept in Diabetic Macular Edema in the 20/50 or Worse Vision Subgroup in Phase III YOSEMITE and RHINE Trials
Purpose: Diabetic Retinopathy Clinical Research Network Protocol T suggests that the response to treatment among patients with diabetic macular edema (DME) may vary depending on baseline best-corrected visual acuity (BCVA). We evaluated the efficacy of faricimab 6 mg versus aflibercept 2 mg over 2 years in patients with DME and baseline BCVA of 20/50 or worse enrolled in faricimab phase III trials. Design: YOSEMITE and RHINE were identically designed, multicenter, randomized, double-masked, active comparator–controlled, noninferiority trials. Participants: Adults ≥18 years of age with center-involving macular edema secondary to type 1 or 2 diabetes.
Methods: Patients were randomized to faricimab every 8 weeks (Q8W), faricimab personalized treat-and-extend (T&E) regimen, or aflibercept Q8W. Post hoc subgroup analyses were conducted using the intention-to-treat population with baseline BCVA of 20/50 or worse. Main Outcome Measures: Changes in ETDRS B CVA and central subfield thickness (CST) from baseline to years 1 and 2 were compared between treatment arms using mixed-model repeated measures analyses.
Results: In YOSEMITE and RHINE, respectively, 220 and 217 patients in the faricimab Q8W arm, 220 and 219 patients in the faricimab T&E arm, and 219 and 214 patients in the aflibercept Q8W arm showed baseline BCVA of 20/50 or worse. In both trials, mean change in ETDRS BCVA was comparable between treatments across trials at years 1 and 2. In YOSEMITE, adjusted mean change from baseline in CST (μm) at year 1 was greater with faricimab Q8W (–232.8; P < 0.0001) and faricimab T&E (–217.4; P = 0.0004)) versus aflibercept Q8W (–190.4). In RHINE, this was faricimab Q8W (–214.2; P = 0.0006) and faricimab T&E (–206.6; P = 0.0116) versus aflibercept Q8W (–186.6). In both trials, change from baseline in CST at year 2 was greater with faricimab Q8W versus aflibercept. The median time to first CST of <325 μ m and first absence of intraretinal fluid was shorter in the faricimab arms versus the aflibercept arm, with fewer injections on average. Conclusions: In patients with DME and baseline ETDRS BCVA of 20/50 or worse, faricimab treatment resulted in comparable visual acuity, greater reduction in retinal thickness, and fewer injections compared with aflibercept. Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. © 2024 American Academy of Ophthalmology
Authors : Zarbin M.; Tabano D.; Ahmed A.; Amador M.; Ding A.; Holekamp N.; Lu X.-Y.; Stoilov I.; Yang M.
Source : Elsevier Inc.
Article Information
| Year | 2024 |
| Type | Article |
| DOI | 10.1016/j.ophtha.2024.05.025 |
| ISSN | 01616420 |
| Volume | 131 |
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