@article{MTMT:35159433, title = {Efficacy of Faricimab versus Aflibercept in Diabetic Macular Edema in the 20/50 or Worse Vision Subgroup in Phase III YOSEMITE and RHINE Trials}, url = {https://m2.mtmt.hu/api/publication/35159433}, author = {Zarbin, Marco and Tabano, David and Ahmed, Ayesha and Amador, Manuel and Ding, Allan and Holekamp, Nancy and Lu, Xiao-Yu and Stoilov, Ivaylo and Yang, Ming}, doi = {10.1016/j.ophtha.2024.05.025}, journal-iso = {OPHTHALMOLOGY}, journal = {OPHTHALMOLOGY}, unique-id = {35159433}, issn = {0161-6420}, year = {2024}, eissn = {1549-4713}, orcid-numbers = {Tabano, David/0000-0001-7657-0809} } @article{MTMT:34883271, title = {Efficacy and Safety of Faricimab for Macular Edema due to Retinal Vein Occlusion: 24-Week Results from the BALATON and COMINO Trials}, url = {https://m2.mtmt.hu/api/publication/34883271}, author = {Tadayoni, R. and Paris, L.P. and Danzig, C.J. and Abreu, F. and Khanani, A.M. and Brittain, C. and Lai, T.Y.Y. and Haskova, Z. and Sakamoto, T. and Kotecha, A. and Schlottmann, P.G. and Liu, Y. and Seres, A. and Retiere, A.-C. and Willis, J.R. and Yoon, Y.H.}, doi = {10.1016/j.ophtha.2024.01.029}, journal-iso = {OPHTHALMOLOGY}, journal = {OPHTHALMOLOGY}, unique-id = {34883271}, issn = {0161-6420}, abstract = {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. © 2024 American Academy of Ophthalmology}, keywords = {Angiopoietin-2; RETINAL VEIN OCCLUSION; vascular endothelial growth factor receptor; faricimab; Macular leakage}, year = {2024}, eissn = {1549-4713} } @article{MTMT:34779507, title = {Is Kidney Function Associated with Age-Related Macular Degeneration?: Findings from the Asian Eye Epidemiology Consortium}, url = {https://m2.mtmt.hu/api/publication/34779507}, author = {Xue, C.C. and Sim, R. and Chee, M.L. and Yu, M. and Wang, Y.X. and Rim, T.H. and Hyung, P.K. and Woong, K.S. and Song, S.J. and Nangia, V. and Panda-Jonas, S. and Wang, N.L. and Hao, J. and Zhang, Q. and Cao, K. and Sasaki, M. and Harada, S. and Toru, T. and Ryo, K. and Raman, R. and Surya, J. and Khan, R. and Bikbov, M. and Wong, I.Y. and Cheung, C.M.G. and Jonas, J.B. and Cheng, C.-Y. and Tham, Y.-C.}, doi = {10.1016/j.ophtha.2023.12.030}, journal-iso = {OPHTHALMOLOGY}, journal = {OPHTHALMOLOGY}, unique-id = {34779507}, issn = {0161-6420}, year = {2024}, eissn = {1549-4713} } @article{MTMT:34735501, title = {Delays between Uveal Melanoma Diagnosis and Treatment Increase the Risk of Metastatic Death}, url = {https://m2.mtmt.hu/api/publication/34735501}, author = {Stålhammar, G.}, doi = {10.1016/j.ophtha.2023.11.021}, journal-iso = {OPHTHALMOLOGY}, journal = {OPHTHALMOLOGY}, unique-id = {34735501}, issn = {0161-6420}, year = {2024}, eissn = {1549-4713} } @article{MTMT:35327660, title = {Association between Glucagon-like Peptide-1 Receptor Agonists and the Risk of Glaucoma in Individuals with Type 2 Diabetes}, url = {https://m2.mtmt.hu/api/publication/35327660}, author = {Niazi, Siar and Gnesin, Filip and Thein, Anna-Sophie and Andreasen, Jens R. and Horwitz, Anna and Mouhammad, Zaynab A. and Jawad, Baker N. and Niazi, Zia and Pourhadi, Nelsan and Zareini, Bochra and Meaidi, Amani and Torp-Pedersen, Christian and Kolko, Miriam}, doi = {10.1016/j.ophtha.2024.03.004}, journal-iso = {OPHTHALMOLOGY}, journal = {OPHTHALMOLOGY}, volume = {131}, unique-id = {35327660}, issn = {0161-6420}, keywords = {glaucoma; Type 2 diabetes; Danish; Nationwide; glucagon-like peptide-1 receptor agonists; Antihyperglycemic medication}, year = {2024}, eissn = {1549-4713}, pages = {1056-1063}, orcid-numbers = {Niazi, Siar/0009-0008-1699-7788; Gnesin, Filip/0000-0002-3566-5155; Thein, Anna-Sophie/0000-0002-5276-8770; Pourhadi, Nelsan/0000-0002-5647-1018; Zareini, Bochra/0000-0002-3891-5957; Kolko, Miriam/0000-0001-8697-0734} } @article{MTMT:35078052, title = {Ocular Mucous Membrane Pemphigoid: The Effect of Risk Factors at Presentation on Treatment Outcomes}, url = {https://m2.mtmt.hu/api/publication/35078052}, author = {Ruiz-Lozano, R.E. and Colorado-Zavala, M.F. and Ramos-Dávila, E.M. and Quiroga-Garza, M.E. and Azar, N.S. and Mousa, H.M. and Hernández-Camarena, J.C. and Stinnett, S.S. and Daluvoy, M. and Kim, T. and Sainz-de-la-Maza, M. and Hall, R.P. 3rd and Rodriguez-Garcia, A. and Perez, V.L.}, doi = {10.1016/j.ophtha.2024.02.028}, journal-iso = {OPHTHALMOLOGY}, journal = {OPHTHALMOLOGY}, volume = {131}, unique-id = {35078052}, issn = {0161-6420}, abstract = {Purpose: Analyze the influence of risk factors at presentation in the long-term immunosuppressive therapy (IMT) outcomes of ocular mucous membrane pemphigoid (OMMP). Design: Retrospective multicenter study. Participants: Patients with OMMP seen at the Duke Eye Center, Tecnologico de Monterrey, and Hospital Clinic of Barcelona from 1990 to 2022. Methods: Data at presentation on demographics, direct immunofluorescence, ocular findings, sites of extraocular manifestations (EOMs), and previous treatments in patients with a clinical or laboratory diagnosis of OMMP, were analyzed with multivariable analysis and Kaplan-Meier plots to identify factors associated with adverse outcomes. Main Outcome Measures: (1) Inflammatory control (no conjunctival inflammation in both eyes at 3 months on IMT); (2) relapse (new-onset inflammation after absolute control in either eye); (3) progression (≥ 1 cicatrizing stage progression in either eye); and (4) vision loss (≥ 2 Snellen lines). Results: A total of 117 patients (234 eyes), 61% (71/117) of whom were women, with a mean age of 66.6 (SD: 12.4) years (range: 37–97 years) and median follow-up of 34 months (interquartile range: 16–66 months; range: 3–265 months), were enrolled. Inflammatory control was achieved in 57% of patients (67/117), with high-risk EOM (HR-EOM), including esophageal, nasopharyngeal, and/or genital involvement (adjusted odds ratio [aOR]: 12.51; 95% confidence interval [CI]: 2.61–59.99; P = 0.002) and corneal scarring (aOR: 3.06; 95% CI, 1.15–8.14; P = 0.025), as significant risk factors for persistent inflammation. Disease relapse, progression, and vision loss occurred in 20% of patients (23/117), 12% of patients (14/117), and 27% of patients (32/117), respectively. Baseline corneal scarring was a risk factor for relapse (adjusted hazard ratio: 4.14; 95% CI: 1.61–10.62; P = 0.003), progression (aOR: 11.46; 95% CI: 1.78–73.75; P = 0.010), and vision loss (aOR: 3.51; 95% CI: 1.35–9.10; P = 0.010). HR-EOM was associated with stage progression (aOR, 34.57; 95% CI, 6.57–181.89; P<0.001) and vision loss (aOR, 8.42; 95% CI, 2.50–28.42; P = 0.001). No significant differences were found between IMT regimes and relapse (P = 0.169). Conclusions: Ocular mucous membrane pemphigoid presenting with HR-EOMs and corneal scarring has an increased risk of stage progression and vision loss. Corneal scarring and severe inflammation at baseline were associated with an increased risk of relapse. A disease progression staging system incorporating both the HR-EOMs and corneal involvement is required to predict the visual outcome of OMMP better. 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}, keywords = {Immunosuppressive therapy; corneal scarring; cicatrizing conjunctivitis; ocular mucous membrane pemphigoid}, year = {2024}, eissn = {1549-4713}, pages = {1064-1075} } @article{MTMT:35327769, title = {Cataract Surgery and Cognitive Benefits fi ts in the Older Person A Systematic Review and Meta-analysis}, url = {https://m2.mtmt.hu/api/publication/35327769}, author = {Yeo, Brian Sheng Yep and Ong, Rebecca Yi Xuan and Ganasekar, Pooja and Tan, Benjamin Kye Jyn and Seow, Dennis Chuen Chai and Tsai, Andrew S. H.}, doi = {10.1016/j.ophtha.2024.02.003}, journal-iso = {OPHTHALMOLOGY}, journal = {OPHTHALMOLOGY}, volume = {131}, unique-id = {35327769}, issn = {0161-6420}, year = {2024}, eissn = {1549-4713}, pages = {975-984} } @article{MTMT:34717989, title = {TENAYA and LUCERNE. Two-Year Results from the Phase 3 Neovascular Age-Related Macular Degeneration Trials of Faricimab with Treat-and-Extend Dosing in Year 2}, url = {https://m2.mtmt.hu/api/publication/34717989}, author = {Arshad, M Khanani and Aachal, Kotecha and Andrew, Chang and Shih-Jen, Chen and Youxin, Chen and Robyn, Guymer and Jeffrey, S Heier and Frank, G Holz and Tomohiro, Iida and Jane, A Ives and Jennifer, I Lim and Hugh, Lin and Stephan, Michels and Carlos, Quezada Ruiz and Ursula, Schmidt-Erfurth and David, Silverman and Rishi, Singh and Balakumar, Swaminathan and Jeffrey, R Willis and Ramin, Tadayoni}, doi = {10.1016/j.ophtha.2024.02.014}, journal-iso = {OPHTHALMOLOGY}, journal = {OPHTHALMOLOGY}, volume = {131}, unique-id = {34717989}, issn = {0161-6420}, abstract = {Purpose: To evaluate 2-year efficacy, durability, and safety of the bispecific antibody faricimab, which inhibits both angiopoietin-2 and VEGF-A. Design: TENAYA (ClinicalTrials.gov identifier, NCT03823287) and LUCERNE (ClinicalTrials.gov identifier, NCT03823300) were identically designed, randomized, double-masked, active comparator-controlled phase 3 noninferiority trials. Participants: Treatment-naive patients with neovascular age-related macular degeneration (nAMD) 50 years of age or older. Methods: Patients were randomized (1:1) to intravitreal faricimab 6.0 mg up to every 16 weeks (Q16W) or aflibercept 2.0 mg every 8 weeks (Q8W). Faricimab fixed dosing based on protocol-defined disease activity at weeks 20 and 24 up to week 60, followed up to week 108 by a treat-and-extend personalized treatment interval regimen. Main Outcome Measures: Efficacy analyses included change in best-corrected visual acuity (BCVA) from baseline at 2 years (averaged over weeks 104, 108, and 112) and proportion of patients receiving Q16W, every 12 weeks (Q12W), and Q8W dosing at week 112 in the intention-to-treat population. Safety analyses included ocular adverse events (AEs) in the study eye through study end at week 112. Results: Of 1326 patients treated across TENAYA/LUCERNE, 1113 (83.9%) completed treatment (n = 555 faricimab; n = 558 aflibercept). The BCVA change from baseline at 2 years was comparable between faricimab and aflibercept groups in TENAYA (adjusted mean change, +3.7 letters [95% confidence interval (CI), +2.1 to +5.4] and +3.3 letters [95% CI, +1.7 to +4.9], respectively; mean difference, +0.4 letters [95% CI, −1.9 to +2.8]) and LUCERNE (adjusted mean change, +5.0 letters [95% CI, +3.4 to +6.6] and +5.2 letters [95% CI, +3.6 to +6.8], respectively; mean difference, −0.2 letters [95% CI, −2.4 to +2.1]). At week 112 in TENAYA and LUCERNE, 59.0% and 66.9%, respectively, achieved Q16W faricimab dosing, increasing from year 1, and 74.1% and 81.2%, achieved Q12W or longer dosing. Ocular AEs in the study eye were comparable between faricimab and aflibercept groups in TENAYA (55.0% and 56.5% of patients, respectively) and LUCERNE (52.9% and 47.5% of patients, respectively) through week 112. Conclusions: Treat-and-extend faricimab treatment based on nAMD disease activity maintained vision gains through year 2, with most patients achieving extended dosing intervals. 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}, year = {2024}, eissn = {1549-4713}, pages = {914-926}, orcid-numbers = {Tóth-Molnár, Edit/0000-0001-7989-1616} } @article{MTMT:35231087, title = {Glycemic Trends in Patients with Thyroid Eye Disease Treated with Teprotumumab in 3 Clinical Trials}, url = {https://m2.mtmt.hu/api/publication/35231087}, author = {Smith, T.J. and Cavida, D. and Hsu, K. and Kim, S. and Fu, Q. and Barbesino, G. and Wester, S.T. and Holt, R.J. and Bhattacharya, R.K.}, doi = {10.1016/j.ophtha.2024.01.023}, journal-iso = {OPHTHALMOLOGY}, journal = {OPHTHALMOLOGY}, volume = {131}, unique-id = {35231087}, issn = {0161-6420}, year = {2024}, eissn = {1549-4713}, pages = {815-826} } @article{MTMT:35051585, title = {Leveraging Real-World Evidence to Enhance Clinical Trials}, url = {https://m2.mtmt.hu/api/publication/35051585}, author = {Borkar, D.S. and Parke, D.W. II and Lee, A.Y.}, doi = {10.1016/j.ophtha.2024.04.014}, journal-iso = {OPHTHALMOLOGY}, journal = {OPHTHALMOLOGY}, volume = {131}, unique-id = {35051585}, issn = {0161-6420}, year = {2024}, eissn = {1549-4713}, pages = {756-758} }