Scott Friedman, Nikolas London, Jan Hamouz, Ágnes Kerényi, Andras Papp, Tamás Pregun, Vincent Chow, Bianca Bautista, Daidong Wang, Gary Grachev, Janet Franklin
{"title":"Randomized Trial of Biosimilar ABP 938 Compared with Reference Aflibercept in Adults with Neovascular Age-Related Macular Degeneration.","authors":"Scott Friedman, Nikolas London, Jan Hamouz, Ágnes Kerényi, Andras Papp, Tamás Pregun, Vincent Chow, Bianca Bautista, Daidong Wang, Gary Grachev, Janet Franklin","doi":"10.1016/j.oret.2025.07.015","DOIUrl":"10.1016/j.oret.2025.07.015","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the clinical efficacy, safety, and immunogenicity of biosimilar ABP 938 compared with the aflibercept reference product (RP) in adults with neovascular (wet) age-related macular degeneration (nAMD).</p><p><strong>Design: </strong>A randomized, double-masked, active-controlled, multiregional clinical study.</p><p><strong>Participants: </strong>A total of 579 patients with active treatment-naïve choroidal neovascularization secondary to nAMD were randomized.</p><p><strong>Methods: </strong>Evaluable patients (N = 576) received 2 mg of ABP 938 (n = 288) or aflibercept RP (n = 288) by intravitreal injection every 4 weeks for the first 3 doses, then every 8 weeks through week 48. At week 16, the ABP 938 group continued on ABP 938 (n = 273), whereas the aflibercept RP group was rerandomized to continue on aflibercept RP (n = 136) or transition to ABP 938 (n = 134).</p><p><strong>Main outcome measures: </strong>The primary efficacy end point was the least squares (LS) mean difference in change in best-corrected visual acuity (BCVA), measured by ETDRS letter score, from baseline to week 8. Secondary efficacy end points, safety, and immunogenicity were analyzed descriptively. In a substudy of patients, serum drug concentration profiles were assessed.</p><p><strong>Results: </strong>Demographic and baseline characteristics and exposure to treatment were similar between groups. Among initially randomized patients, the LS mean difference in change from baseline in BCVA at week 8 between ABP 938 and aflibercept RP was 0.1, with a 2-sided 95% confidence interval (CI: -1.3, 1.5) and 90% CI (-1.1, 1.3) falling within prespecified similarity margins (-3.9, 3.9, and -3, 3, respectively); thus, the primary clinical efficacy end point was met. Secondary efficacy end points (parallel-arm and posttransition) were overall similar between groups. No clinically meaningful differences were observed in the incidence of ocular and nonocular adverse events or events of interest. A low and similar incidence of binding antidrug antibodies was observed in all groups. The substudy confirmed low systemic exposure of free drug concentrations of ABP 938 and aflibercept RP.</p><p><strong>Conclusions: </strong>This study supports the conclusion of no clinically meaningful differences in efficacy, safety, and immunogenicity between ABP 938 and aflibercept RP in patients with nAMD. Additionally, transitioning from aflibercept RP to APB 938 at week 16 resulted in comparable efficacy, safety, and immunogenicity between treatment groups.</p><p><strong>Financial disclosure(s): </strong>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</p>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144794945","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alessandro Feo MD , Andrea Govetto MD, PhD , Prithvi Ramtohul MD , Néda Abraham MSc , Diogo Cabral MD , Peter Y. Chang MD , Nauman Chaudhry MD , Fred K. Chen MBBS, PhD , Dean Eliott MD , Livia Faes MD , Rachael C. Heath Jeffery MChD MPH , Sarah Mrejen MD , Marko M. Popovic MD, MPH , Marisa G. Tieger MD , Luca Zatreanu MD , SriniVas R. Sadda MD, FARVO , K. Bailey Freund MD , Mario R. Romano MD, PhD , David Sarraf MD
{"title":"Stellate Nonhereditary Idiopathic Foveomacular Retinoschisis and Central Anomalous Retinoschisis with mid-PEripheral Traction","authors":"Alessandro Feo MD , Andrea Govetto MD, PhD , Prithvi Ramtohul MD , Néda Abraham MSc , Diogo Cabral MD , Peter Y. Chang MD , Nauman Chaudhry MD , Fred K. Chen MBBS, PhD , Dean Eliott MD , Livia Faes MD , Rachael C. Heath Jeffery MChD MPH , Sarah Mrejen MD , Marko M. Popovic MD, MPH , Marisa G. Tieger MD , Luca Zatreanu MD , SriniVas R. Sadda MD, FARVO , K. Bailey Freund MD , Mario R. Romano MD, PhD , David Sarraf MD","doi":"10.1016/j.oret.2025.01.019","DOIUrl":"10.1016/j.oret.2025.01.019","url":null,"abstract":"<div><h3>Purpose</h3><div>To report the clinical and multimodal imaging (MMI) findings and long-term follow-up of stellate nonhereditary idiopathic foveomacular retinoschisis (SNIFR) contiguous with midperipheral retinoschisis (MPRS) and to describe a severe SNIFR variant termed CARPET (Central Anomalous Retinoschisis with mid-PEripheral Traction).</div></div><div><h3>Design</h3><div>Retrospective case series.</div></div><div><h3>Subjects</h3><div>Eleven patients (15 eyes) with SNIFR contiguous with MPRS in at least 1 eye at baseline or final follow-up.</div></div><div><h3>Methods</h3><div>Multimodal imaging features, including cross-sectional and en face macular and peripheral spectral-domain OCT and OCT angiography, were reviewed in all cases at baseline and at the final follow-up visit.</div></div><div><h3>Main Outcome Measures</h3><div>Various courses (including progression, regression, or stability) of MPRS or SNIFR over time were evaluated.</div></div><div><h3>Results</h3><div>Midperipheral retinoschisis exhibited centripetal progression to SNIFR in 5 eyes of 3 patients with follow-up of 67, 60, and 27 months, respectively, with maintenance of excellent visual acuity (range: 20/25–20/20) in 4 of these 5 eyes. In 2 eyes of 2 patients (including 1 eye with initial centripetal progression of MPRS to SNIFR), MPRS contiguous with SNIFR spontaneously resolved with long-term follow-up (77 and 25 months, respectively). Stellate nonhereditary idiopathic foveomacular retinoschisis contiguous with MPRS partially regressed after 48 months in 1 patient, and was stable after 54 months in another. A distinctive midperipheral microvasculopathy, associated with MPRS that was contiguous with SNIFR, was identified in 7 eyes of 4 patients. Finally, 3 eyes of 3 patients exhibited additional unique features, including central neurosensory detachment and outer lamellar macular hole, which were associated with significant midperipheral traction, representing a severe variant subtype of SNIFR that we refer to as CARPET. Two of these 3 eyes progressed with short-term follow-up of 6 and 2 months, respectively, whereas the schisis resolved and vision improved after pars plana vitrectomy in the third case.</div></div><div><h3>Conclusions</h3><div>Midperipheral retinoschisis can progress to SNIFR over multiple years of follow-up. Stellate nonhereditary idiopathic foveomacular retinoschisis with MPRS can also spontaneously resolve or remain stable. Midperipheral retinoschisis can additionally be complicated by a midperipheral inner retinal microvasculopathy. Finally, CARPET may represent a unique and severe variant form of SNIFR driven by midperipheral vitreoretinal traction and associated with significant vision loss.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 8","pages":"Pages 747-755"},"PeriodicalIF":5.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Glenn J. Jaffe MD , Briana Cameron PhD , Giulio Barteselli MD , Natalia Callaway MD, MS , Cindy Skalak RN, COT , John Choong BS , Shamika Gune MD
{"title":"Macular Atrophy-Related Observations in Eyes Treated with the Port Delivery System with Ranibizumab in the Archway Trial","authors":"Glenn J. Jaffe MD , Briana Cameron PhD , Giulio Barteselli MD , Natalia Callaway MD, MS , Cindy Skalak RN, COT , John Choong BS , Shamika Gune MD","doi":"10.1016/j.oret.2025.02.017","DOIUrl":"10.1016/j.oret.2025.02.017","url":null,"abstract":"<div><h3>Purpose</h3><div>To compare the development of macular atrophy (MA) in eyes treated with the Port Delivery System with ranibizumab (PDS) with those treated with monthly intravitreal ranibizumab injections in the Archway trial.</div></div><div><h3>Design</h3><div>Preplanned exploratory analysis of a phase III, open-label, randomized trial.</div></div><div><h3>Participants</h3><div>Patients with neovascular age-related macular degeneration (nAMD) diagnosed within 9 months of screening, previously treated with and responsive to anti-VEGF therapy.</div></div><div><h3>Methods</h3><div>Eyes were randomized 3:2 to treatment with the PDS 100 mg/ml with fixed 24-week (Q24W) refill-exchanges (PDS Q24W) or intravitreal ranibizumab 0.5 mg injections every 4 weeks (monthly ranibizumab).</div></div><div><h3>Main Outcome Measures</h3><div>Prevalence, incidence, and progression of MA.</div></div><div><h3>Results</h3><div>The analysis population consisted of 415 eyes (248 and 167 eyes in the PDS Q24W and monthly ranibizumab arms, respectively). At the study baseline, MA was observed in 22.3% (PDS Q24W) and 20.4% (monthly ranibizumab) of eyes. At week 96, the prevalence of MA was 39.1% and 39.2%, whereas the incidence of new MA in eyes without MA at baseline was 20.0% and 22.6% in the PDS Q24W and monthly ranibizumab arms, respectively. In eyes without baseline MA, the mean MA area at week 96 was 0.4 in the PDS Q24W arm and 3.8 mm<sup>2</sup> in the monthly ranibizumab arm with a difference of 3.4 mm<sup>2</sup>, (<em>P</em> = 0.054) favoring the PDS. In eyes with baseline MA, the mean change in MA area from baseline to week 96 was +2.2 mm<sup>2</sup> for both the PDS Q24W and monthly ranibizumab arms.</div></div><div><h3>Conclusions</h3><div>In the Archway trial, which compared PDS Q24W with monthly ranibizumab injections for nAMD treatment over 2 years, the prevalence and incidence of MA were similar between arms over the study duration. In eyes without baseline MA, PDS-treated eyes had less MA area by 3.4 mm<sup>2</sup>, a potentially clinically meaningful (although not statistically significant) difference. The results of this prespecified exploratory analysis suggest that PDS treatment is not associated with a higher incidence or progression of MA when compared with monthly injections of ranibizumab. In eyes without baseline MA, the progression of the atrophy area was 4 times less in PDS-treated eyes. Additional studies could further elucidate this observation.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 8","pages":"Pages 767-773"},"PeriodicalIF":5.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143524066","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nimesh A. Patel MD , Luis A. Acaba-Berrocal MD , Sandra Hoyek MD , Celine Chaaya MD, MSc , Kenneth C. Fan MD , Maria Ana Martinez-Castellanos MD , Caroline R. Baumal MD , Clio Armitage Harper III MD , Audina M. Berrocal MD
{"title":"United States versus Non-United States Retreatment Rates after Intravitreal Anti-VEGF Injections for Retinopathy of Prematurity","authors":"Nimesh A. Patel MD , Luis A. Acaba-Berrocal MD , Sandra Hoyek MD , Celine Chaaya MD, MSc , Kenneth C. Fan MD , Maria Ana Martinez-Castellanos MD , Caroline R. Baumal MD , Clio Armitage Harper III MD , Audina M. Berrocal MD","doi":"10.1016/j.oret.2025.03.013","DOIUrl":"10.1016/j.oret.2025.03.013","url":null,"abstract":"","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 8","pages":"Pages 812-814"},"PeriodicalIF":5.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143710852","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kirill Zaslavsky, Christopher F Barile, Jason I Comander
{"title":"Giant Macular Hole in Enhanced S-Cone Syndrome.","authors":"Kirill Zaslavsky, Christopher F Barile, Jason I Comander","doi":"10.1016/j.oret.2025.07.004","DOIUrl":"https://doi.org/10.1016/j.oret.2025.07.004","url":null,"abstract":"","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144768837","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Daniela Bacherini MD, PhD , Stefano Mercuri MD , Andrea Govetto MD, PhD , Laura Di Leo MD , Tomaso Caporossi MD , Francesco Faraldi MD , Stanislao Rizzo MD , Gianni Virgili MD , Fabrizio Giansanti MD, PhD
{"title":"Multimodal Imaging Analysis of Supra-retinal Pigment Epithelium Granular Deposits in Treatment-Naive Full-Thickness Macular Holes","authors":"Daniela Bacherini MD, PhD , Stefano Mercuri MD , Andrea Govetto MD, PhD , Laura Di Leo MD , Tomaso Caporossi MD , Francesco Faraldi MD , Stanislao Rizzo MD , Gianni Virgili MD , Fabrizio Giansanti MD, PhD","doi":"10.1016/j.oret.2025.02.016","DOIUrl":"10.1016/j.oret.2025.02.016","url":null,"abstract":"<div><h3>Purpose</h3><div>To describe the morphology and provide anatomical correlations of supra-retinal pigment epithelium (RPE) granular deposits in full-thickness macular holes (FTMHs).</div></div><div><h3>Design</h3><div>Retrospective, observational, single-center study.</div></div><div><h3>Participants</h3><div>Patients with idiopathic FTMH presenting to the University of Florence Eye clinic.</div></div><div><h3>Methods</h3><div>Thirty-six eyes of 34 patients with a diagnosis of treatment-naive FTMH, scheduled for surgery, underwent multimodal imaging including spectral-domain OCT (SD-OCT), en-face OCT, and adaptive optics ophthalmoscopy (AOO). Different methodologies were evaluated to determine the location and topographical correspondence of granulations. The total volume of supra-RPE granular deposits was correlated to the macular hole (MH) characteristics and SD-OCT markers of photoreceptor damage with Spearman correlation coefficient (CC).</div></div><div><h3>Main Outcome Measures</h3><div>Morphological correlations in FTMHs using SD-OCT and AOO.</div></div><div><h3>Results</h3><div>Using AOO, supra-RPE granular deposits appeared as hyper-reflective structures, mostly found within the minimum linear diameter (MLD) (104 of 139 deposits, 74%). Different imaging techniques were equally effective in the topographical identification of supra-RPE granular deposits (<em>P</em> > 0.30). The total volume of supra-RPE granular deposits significantly increased with stages B and C of FTMH, inversely correlated to the corrected ellipsoid zone (EZ) reflectivity (CC = −0.62) and positively correlated to the length of the EZ defect (CC = +0.41) and MH diameter at the base (CC = +0.35) and MLD (CC = +0.42) (all <em>P</em> < 0.05).</div></div><div><h3>Conclusions</h3><div>Supra-RPE granular deposits can be identified accurately using AOO and en-face OCT. Characteristics using AOO and anatomical correlations at SD-OCT indicate supra-RPE granular deposits as signs of photoreceptor degeneration.</div></div><div><h3>Financial Disclosure(s)</h3><div>The authors have no proprietary or commercial interest in any materials discussed in this article.</div></div>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 8","pages":"Pages 731-738"},"PeriodicalIF":5.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143516281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}