Jaffe Glenn J, Deák Gábor, Gibson Kara, Khurana Rahul N, Nudleman Eric, Ogura Yuichiro, Schmidt-Erfurth Ursula, Wang Tracey, Westenskow Peter D, Wong David, Yiu Glenn, Willis Jeffrey R
Department of Ophthalmology, Duke University, Durham, North Carolina.
Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.
Retina. 2025 Jul 14. doi: 10.1097/IAE.0000000000004572.
To assess the effects of faricimab versus aflibercept on epiretinal membrane (ERM) formation in eyes with diabetic macular edema (DME).
Post hoc analysis of phase 3 YOSEMITE/RHINE trial data in eyes with DME receiving faricimab Q8W, faricimab treat-and-extend (T&E; up to Q16W depending on central subfield thickness [CST] and best-corrected visual acuity [BCVA]), or aflibercept Q8W for 100 weeks.
ERMs developed in 3.8% (23/602) of eyes treated with faricimab Q8W, 5.1% (31/608) with faricimab T&E, and 7.6% (45/590) with aflibercept Q8W at 100 weeks. ERMs were less likely with faricimab Q8W versus aflibercept Q8W (odds ratio [OR] 0.48, 95% confidence interval [CI] 0.29-0.81, P = 0.0055). Mean (SD) BCVA at 100 weeks in eyes with and without ERMs were 69.2 (13.6) letters [20/40 Snellen] versus 73.8 (13.1) [20/40 Snellen], respectively; mean (SD) CSTs were 315.8 (99.2) vs. 274.6 (74.1) µm. Faricimab T&E dosing intervals were extended ≥ Q12W in 79.7% of eyes without ERMs versus 50.0% with ERMs.
Risk of ERMs was 52% lower with faricimab Q8W versus aflibercept Q8W over 100 weeks in eyes with DME, suggesting a potential role for faricimab in reducing pre-retinal fibrotic proliferation. Results may help inform physician/patient decision-making when initiating intravitreal therapy.
评估faricimab与阿柏西普对糖尿病性黄斑水肿（DME）眼视网膜前膜（ERM）形成的影响。
对3期YOSEMITE/RHINE试验数据进行事后分析，该试验中患有DME的眼睛接受每8周一次的faricimab、faricimab治疗并延长给药间隔（T&E；根据中心子野厚度[CST]和最佳矫正视力[BCVA]，最长可达每16周一次）或每8周一次的阿柏西普治疗，为期100周。
在100周时，接受每8周一次faricimab治疗的眼中有3.8%（23/602）发生ERM，接受faricimab T&E治疗的眼中有5.1%（31/608）发生ERM，接受每8周一次阿柏西普治疗的眼中有7.6%（45/590）发生ERM。与每8周一次阿柏西普相比，每8周一次faricimab发生ERM的可能性更低（优势比[OR]0.48，95%置信区间[CI]0.29 - 0.81，P = 0.0055）。有ERM和无ERM的眼睛在100周时的平均（标准差）BCVA分别为69.2（13.6）字母[Snellen 20/40]和73.8（13.1）[Snellen 20/40]；平均（标准差）CST分别为315.8（99.2）和274.6（74.1）µm。在无ERM的眼中，79.7%的faricimab T&E给药间隔延长至≥每12周一次，而在有ERM的眼中，这一比例为50.0%。
在患有DME的眼中，与每8周一次阿柏西普相比，每8周一次faricimab在100周内发生ERM的风险降低了52%，这表明faricimab在减少视网膜前纤维化增殖方面可能具有潜在作用。这些结果可能有助于在启动玻璃体内治疗时为医生/患者的决策提供参考。
