Efficacy and Safety of Faricimab for Macular Edema due to Retinal Vein Occlusion: 24-Week Results from the BALATON and COMINO Trials.

PURPOSE: To evaluate the 24-week efficacy and safety of the dual angiopoietin-2 (Ang-2) and vascular endothelial growth factor (VEGF)-A inhibitor faricimab versus aflibercept in patients with vein occlusion. DESIGN: Phase 3, global, randomized, double-masked, active comparator-controlled trials: BALATON/COMINO (ClincalTrials.gov identifiers: NCT04740905/NCT04740931; sites: 149/192). PARTICIPANTS: Patients with treatment-naïve foveal center-involved macular edema resulting from branch (BALATON) or central or hemiretinal (COMINO) RVO. METHODS: Patients were randomized 1:1 to faricimab 6.0 mg or aflibercept 2.0 mg every 4 weeks for 24 weeks. MAIN OUTCOME MEASURES: Primary end point: change in best-corrected visual acuity (BCVA) from baseline to week 24. Efficacy analyses included patients in the intention-to-treat population. Safety analyses included patients who received ≥ 1 doses of study drug. RESULTS: Enrollment: BALATON, n = 553; COMINO, n = 729. The BCVA gains from the baseline to week 24 with faricimab were noninferior versus aflibercept in BALATON (adjusted mean change, +16.9 letters [95.03% confidence interval (CI), 15.7-18.1 letters] vs. +17.5 letters [95.03% CI, 16.3-18.6 letters]) and COMINO (+16.9 letters [95.03% CI, 15.4-18.3 letters] vs. +17.3 letters [95.03% CI, 15.9-18.8 letters]). Adjusted mean central subfield thickness reductions from the baseline were comparable for faricimab and aflibercept at week 24 in BALATON (-311.4 µm [95.03% CI, -316.4 to -306.4 µm] and -304.4 µm [95.03% CI, -309.3 to -299.4 µm]) and COMINO (-461.6 µm [95.03% CI, -471.4 to -451.9 µm] and -448.8 µm [95.03% CI, -458.6 to -439.0 µm]). A greater proportion of patients in the faricimab versus aflibercept arm achieved absence of fluorescein angiography-based macular leakage at week 24 in BALATON (33.6% vs. 21.0%; nominal P = 0.0023) and COMINO (44.4% vs. 30.0%; nominal P = 0.0002). Faricimab was well tolerated, with an acceptable safety profile comparable with aflibercept. The incidence of ocular adverse events was similar between patients receiving faricimab (16.3% [n = 45] and 23.0% [n = 84] in BALATON and COMINO, respectively) and aflibercept (20.4% [n = 56] and 27.7% [n = 100], respectively). CONCLUSIONS: These findings demonstrate the efficacy and safety of faricimab, a dual Ang-2/VEGF-A inhibitor, in patients with macular edema secondary to retinal vein occlusion. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Wide-Field Fluorescein Angiography in Patients with Idiopathic Acute Anterior Uveitis.

PURPOSE: To elucidate whether wide-field fluorescein angiography (WFFA) can yield additional information in patients with newly diagnosed idiopathic acute anterior uveitis (AAU). METHODS: The WFFA was performed in patients with idiopathic AAU, and the findings were analyzed according to the scoring system by Angiography Scoring for Uveitis Nomenclature. RESULTS: Forty-four eyes of 30 patients (22 eyes of 13 patients in the pediatric group and 22 eyes of 17 patients in the adult group) were studied. The mean age was 12.41 ± 3.92 (range, 5-18) years in the pediatric group and 42.36 ± 32.07 (range, 24-68) years in the adult group. Thirteen eyes (59%) of pediatric patients and 12 eyes (54%) of adult patients showed some evidence of posterior segment activity on the WFFA (p = .764).     Systemic treatment was administered in 53.8% of the pediatric and 5.9% of adult patients, depending on the disease severity. CONCLUSION: Pediatric patients with idiopathic AAU may have subtle posterior segment manifestations more than adult patients, and posterior segment findings may affect the treatment preferences of physicians.

Are optical coherence tomography and fluorescein angiography comparable for detection of macular edema in Behçet uveitis?

PURPOSE: To investigate the role and agreement of spectral domain optical coherence tomography (SD-OCT) and fluorescein angiography (FA) for macular edema (ME) diagnosis in Behçet uveitis (BU). METHODS: Eyes with ME detected by SD-OCT and/or FA were enrolled. Type of ME by SD-OCT and grade of macular leakage (ML) by FA were investigated. Eyes were divided into three groups according to the agreement of tests. Three groups and factors that could affect the compatibility of tests were statistically analyzed. RESULTS: Sixty-one eyes of 61 patients were included. Both imaging methods detected ME in 42.6% of eyes (group 1). In 47.5% of eyes, ME was revealed by OCT (group 2). The remaining 9.8% of the eyes had ME, detected only by FA (group 3). Grade 2 ML by FA was more common in group 1 (p = 0.01). The grade of ML by FA was similar in groups 2 and 3. In group 2, most of the eyes showed diffuse ME by OCT (p < 0.001). Epiretinal membrane was detected more frequently in group 3 (p = 0.005). Duration and activity of uveitis were similar between groups. CONCLUSION: SD-OCT was able to detect ME in 90% of the eyes with BU. Duration and activity of uveitis were not related to the compatibility of imaging methods.

A randomized clinical trial comparing prompt photodynamic therapy with 3 months observation in patients with acute central serous chorioretinopathy with central macular leakage.

PURPOSE: The purpose of the study was to demonstrate whether photodynamic therapy in patients with acute central serous chorioretinopathy, with the leakage point within one optic disk diameter from the fovea, can be safely deferred. METHODS: A single-center, randomized, controlled trial was conducted. Patients were randomized to photodynamic therapy within a week after presentation (Group I, 26 patients) or observation during 3 months (Group II, 26 patients). If leakage or subretinal fluid was observed during any control visit, photodynamic therapy was performed (again) within a week. PRIMARY OUTCOME: Primary outcome was change of visual acuity (Early Treatment Diabetic Retinopathy Study) after 12 months. Secondary outcomes were visual acuity, central foveal thickness, metamorphopsia, and color discrimination. RESULTS: Photodynamic therapy procedures: group I, 26 at baseline, 2 retreatments at 3 months; group II, 10 at 3 months, 1 at 6 months (2 subjects refusing treatment), 2 retreatments at 6 months. At 12 months, mean visual acuity of all patients had improved by 6.5 letters (P < 0.001), mean central foveal thickness was 172 µm less (P < 0.001). After photodynamic therapy, visual acuity recovered faster and metamorphopsia significantly improved (3 months, P < 0.001). Differences between groups at 12 months were not significant. CONCLUSION: The (intended) number of photodynamic therapy (re)treatments in group II (n = 15) was 46% less than in group I (n = 28). Visual acuity and central foveal thickness at 12 months were similar. Therefore, the preferred management of acute central serous chorioretinopathy at presentation appears to be observation for 3 months.