Ophthalmology and Therapy最新文献

{"title":"Diabetic Disease of the Eye in Canada: Consensus Statements from a Retina Specialist Working Group.","authors":"Amer Omar, R Geoff Williams, James Whelan, Jason Noble, Michael H Brent, Michel Giunta, Sébastien Olivier, Mustapha Lhor","doi":"10.1007/s40123-024-00923-0","DOIUrl":"10.1007/s40123-024-00923-0","url":null,"abstract":"<p><p>Despite advances in systemic care, diabetic disease of the eye (DDE) remains the leading cause of blindness worldwide. There is a critical gap of up-to-date, evidence-based guidance for ophthalmologists in Canada that includes evidence from recent randomized controlled trials. Previous guidance has not always given special consideration to applying treatments and managing DDE in the context of the healthcare system. This consensus statement aims to assist practitioners in the field by providing a spectrum of acceptable opinions on DDE treatment and management from recognized experts in the field. In compiling evidence and generating consensus, a working group of retinal specialists in Canada addressed clinical questions surrounding the four themes of disease, patient, management, and collaboration. The working group reviewed literature representing the highest level of evidence on DDE and shared their opinions on topics surrounding the epidemiology and pathophysiology of diabetic retinopathy and diabetic macular edema; diagnosis and monitoring; considerations around diabetes medication use; strategic considerations for management given systemic comorbidities, ocular comorbidities, and pregnancy; treatment goals and modalities for diabetic macular edema, non-proliferative and proliferative diabetic retinopathy, and retinal detachment; and interdisciplinary collaboration. Ultimately, this work highlighted that the retinal examination in DDE not only informs the treating ophthalmologist but can serve as a global index for disease progression across many tissues of the body. It highlighted further that DDE can be treated regardless of diabetic control, that a systemic approach to patient care will result in the best health outcomes, and prevention of visual complications requires a multidisciplinary management approach. Ophthalmologists must tailor their clinical approach to the needs and circumstances of individual patients and work within the realities of their healthcare setting.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11039592/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140288612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhancing Diabetic Macular Edema Treatment Outcomes: Exploring the ESASO Classification and Structural OCT Biomarkers.","authors":"Giacomo Panozzo, Maria V Cicinelli, Giulia Dalla Mura, Diana Giannarelli, Maria Vadalà, Vincenza Bonfiglio, Giovanni Bellisario, Francesco Bandello","doi":"10.1007/s40123-024-00925-y","DOIUrl":"10.1007/s40123-024-00925-y","url":null,"abstract":"<p><strong>Introduction: </strong>This study assessed the European School of Advanced Studies in Ophthalmology (ESASO) classification's prognostic value for diabetic macular edema (DME) in predicting intravitreal therapy outcomes.</p><p><strong>Methods: </strong>In this retrospective, multicenter study, patients aged > 50 years with type 1 or 2 diabetes and DME received intravitreal antivascular endothelial growth factor (anti-VEGF) agents (ranibizumab, bevacizumab, and aflibercept) or steroids (dexamethasone). The primary outcome was visual acuity (VA) change post-treatment, termed as functional response, measured 4-6 weeks post-third anti-VEGF or 12-16 weeks post-steroid injection, stratified by initial DME stage.</p><p><strong>Results: </strong>Of the 560 eyes studied (62% male, mean age 66.7 years), 31% were classified as stage 1 (early), 50% stage 2 (advanced), 17% stage 3 (severe), and 2% stage 4 (atrophic). Visual acuity (VA; decimal) improved by 0.12-0.15 decimals in stages 1-2 but only 0.03 decimal in stage 3 (all p < 0.0001) and 0.01 in stage 4 (p = 0.38). Even in eyes with low baseline VA ≤ 0.3, improvements were significant only in stages 1 and 2 (0.12 and 0.17 decimals, respectively). Central subfield thickness (CST) improvement was greatest in stage 3 (-229 µm, 37.6%, p < 0.0001), but uncorrelated with VA gains, unlike stages 1 and 2 (respectively: -142 µm, 27.4%; - 5 µm, 12%; both p < 0.0001). Stage 4 showed no significant CST change. Baseline disorganization of retinal inner layers and focal damage of the ellipsoid zone/external limiting membrane did not influence VA improvement in stages 1 and 2. Treatment patterns varied, with 61% receiving anti-VEGF and 39% dexamethasone, influenced by DME stage, with no significant differences between therapeutic agents.</p><p><strong>Conclusion: </strong>The ESASO classification, which views the retina as a neurovascular unit and integrates multiple biomarkers, surpasses single biomarkers in predicting visual outcomes. Significant functional improvement occurred only in stages 1 and 2, suggesting reversible damage, whereas stages 3 and 4 likely reflect irreversible damage.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11039609/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140294122","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Characteristics and Treatment of Ophthalmic Sequelae of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis at a Tertiary Eyecare Centre in Hungary.","authors":"Gábor Tóth, Andrea Lukács, Tanja Stachon, Frank Schirra, Gábor László Sándor, Zoltán Zsolt Nagy, Nóra Szentmáry","doi":"10.1007/s40123-024-00924-z","DOIUrl":"10.1007/s40123-024-00924-z","url":null,"abstract":"<p><strong>Introduction: </strong>This study analysed the causative factors and clinical characteristics of acute and chronic ocular sequelae of Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN) treated at a large third-referral centre in a developed country (Hungary) over a 15-year period.</p><p><strong>Methods: </strong>This was a retrospective review of patients with acute and/or chronic SJS/TEN who were managed between 2006 and 2020 at the Department of Ophthalmology of Semmelweis University in Budapest, Hungary. For each subject, clinical data, including patient demographics, clinical history, causative agents of SJS/TEN, and conservative and surgical treatment details, were reviewed.</p><p><strong>Results: </strong>Ninety-six eyes of 48 patients were included (28 female; 58.3%); the age at disease onset was 32.1 ± 22.4 years. The most common causative factors were medicines (n = 36; 75.0%). Among these drugs, 29.2% were nonsteroidal anti-inflammatory drugs (NSAIDs) (n = 14), 20.8% were antibiotics (n = 10) and 14.6% were antiepileptic drugs (n = 7). In patients with chronic SJS/TEN, the most commonly found ocular sequelae were conjunctival hyperaemia in 45 (56.3%) eyes, symblepharon in 38 (47.5%) eyes, trichiasis/distichiasis in 37 (46.3%) eyes, corneal neovascularization in 31 (38.8%) eyes and corneal scarring in 29 (36.3%) eyes. In patients with chronic SJS/TEN, the most frequently used topical conservative treatment included antibiotics in 53 (66.3%) eyes, preservative-free artificial tears in 50 (62.5%) eyes and topical corticosteroids in 42 (52.5%) eyes of 40 patients. The most frequently performed ocular surgeries for managing chronic ocular sequelae in patients with SJS/TEN were epilation for trichiasis (n = 27; 33.8%), cataract surgery (n = 14; 17.5%), entropion surgery (n = 12; 15.0%), penetrating keratoplasty (PK) (n = 11; 13.8%) and amniotic membrane transplantation (n = 4; 5.0%).</p><p><strong>Conclusion: </strong>Our results suggest that NSAIDs, antibiotics and antiepileptic drugs are the most common causative factors for SJS/TEN in Hungary. Like in other countries, in Hungary, the ocular management of patients with acute and chronic SJS/TEN is heterogeneous, and most cases do not follow modern therapeutic guidelines.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11039596/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140175782","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of a Digital Amsler Grid (PocDoc) for Macular Disease Screening: A Comparative Analysis with the Conventional Method.","authors":"Joewee Boon, William Rojas-Carabali, Yusra Asad, Jonathan Tzien Yih Lim, Rajesh Rajagopalan, Rupesh Agrawal","doi":"10.1007/s40123-024-00910-5","DOIUrl":"10.1007/s40123-024-00910-5","url":null,"abstract":"<p><strong>Introduction: </strong>Macular diseases are major contributors to visual impairment and blindness worldwide. This study introduces PocDoc, a digital version of the conventional Amsler grid, aimed at enhancing the screening and monitoring of macular diseases. We conducted a comprehensive evaluation to compare the effectiveness of PocDoc against the conventional method.</p><p><strong>Methods: </strong>Our comparative analysis involved two distinct phases. Initially, we assessed the capability of both PocDoc and the conventional method in detecting central visual field abnormalities. This phase included a cohort of 72 healthy and 155 eyes affected by various conditions such as age-related macular degeneration (AMD), uveitis, polypoidal choroidal vasculopathy (PCV), and macular telangiectasia. We primarily focused on the area of compromise and observed the correlation between the results obtained from both methods, measuring their concordance using a correlation coefficient. In the second phase, we evaluated the accuracy of both methods in diagnosing AMD. This involved a group of 127 eyes, including 70 healthy and 57 AMD-affected eyes. We determined the sensitivity, specificity, and overall accuracy of each method in diagnosing AMD.</p><p><strong>Results: </strong>In the initial phase, both PocDoc and the conventional Amsler grid demonstrated a high correlation in detecting central visual field defects across various macular diseases (correlation coefficient > 0.9). In the second phase, focused on AMD diagnosis, PocDoc showed a sensitivity of 50%, specificity of 100%, and an overall accuracy of 78%. Comparatively, the conventional method exhibited a sensitivity of 49%, specificity of 100%, and accuracy of 77%.</p><p><strong>Conclusion: </strong>PocDoc's digital Amsler grid exhibits comparable effectiveness to the conventional method in both detecting visual field abnormalities across a range of macular diseases and specifically in the diagnosis of AMD. The high correlation in results, combined with the digital advantages of PocDoc, such as ease of use and potential for telemedicine applications, suggests its viability as a valuable tool in the screening and monitoring of macular diseases.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11039616/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140175783","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Automatic Detection of 30 Fundus Diseases Using Ultra-Widefield Fluorescein Angiography with Deep Experts Aggregation.","authors":"Xiaoling Wang, He Li, Hongmei Zheng, Gongpeng Sun, Wenyu Wang, Zuohuizi Yi, A'min Xu, Lu He, Haiyan Wang, Wei Jia, Zhiqing Li, Chang Li, Mang Ye, Bo Du, Changzheng Chen","doi":"10.1007/s40123-024-00900-7","DOIUrl":"10.1007/s40123-024-00900-7","url":null,"abstract":"<p><strong>Introduction: </strong>Inaccurate, untimely diagnoses of fundus diseases leads to vision-threatening complications and even blindness. We built a deep learning platform (DLP) for automatic detection of 30 fundus diseases using ultra-widefield fluorescein angiography (UWFFA) with deep experts aggregation.</p><p><strong>Methods: </strong>This retrospective and cross-sectional database study included a total of 61,609 UWFFA images dating from 2016 to 2021, involving more than 3364 subjects in multiple centers across China. All subjects were divided into 30 different groups. The state-of-the-art convolutional neural network architecture, ConvNeXt, was chosen as the backbone to train and test the receiver operating characteristic curve (ROC) of the proposed system on test data and external test date. We compared the classification performance of the proposed system with that of ophthalmologists, including two retinal specialists.</p><p><strong>Results: </strong>We built a DLP to analyze UWFFA, which can detect up to 30 fundus diseases, with a frequency-weighted average area under the receiver operating characteristic curve (AUC) of 0.940 in the primary test dataset and 0.954 in the external multi-hospital test dataset. The tool shows comparable accuracy with retina specialists in diagnosis and evaluation.</p><p><strong>Conclusions: </strong>This is the first study on a large-scale UWFFA dataset for multi-retina disease classification. We believe that our UWFFA DLP advances the diagnosis by artificial intelligence (AI) in various retinal diseases and would contribute to labor-saving and precision medicine especially in remote areas.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11039585/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139983448","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analytical and Functional Similarity of Aflibercept Biosimilar ABP 938 with Aflibercept Reference Product.","authors":"Neungseon Seo, Xiaoyan Guan, Tian Wang, Hyo S Helen Chung, Mats Wikström, Rupa Padaki, Kevin Kalenian, Scott Kuhns, Kelli Matthies, Jill Crouse-Zeineddini, Helen Y Wong, Michael Ng, Ian N Foltz, Shawn Cao, Jennifer Liu","doi":"10.1007/s40123-024-00914-1","DOIUrl":"10.1007/s40123-024-00914-1","url":null,"abstract":"<p><strong>Introduction: </strong>ABP 938 is being developed as a biosimilar candidate to aflibercept reference product (RP), a biologic used for certain angiogenic eye disorders. This study was designed to provide a comparative analytical assessment of the structural and functional attributes of ABP 938 and aflibercept RP sourced from the United States (US) and the European Union (EU).</p><p><strong>Methods: </strong>Structural and functional characterization studies were performed using state-of-the-art analytical techniques that were appropriate to assess relevant quality attributes and capable of detecting qualitative and quantitative differences in primary structure, higher-order structure and biophysical properties, product-related substances and impurities, general properties, and biological activities.</p><p><strong>Results: </strong>ABP 938 had the same amino acid sequence and exhibited similar secondary and tertiary structures, and biological activity as aflibercept RP. There were minor differences in a small number of biochemical attributes which are not expected to impact clinical performance. In addition, aflibercept RP sourced from the US and EU were analytically similar.</p><p><strong>Conclusions: </strong>ABP 938 was structurally and functionally similar to aflibercept RP. Since aflibercept RP sourced from the US and EU were analytically similar, this allows for the development of a scientific bridge such that a single-source RP can be used in nonclinical and clinical studies.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11039433/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140175819","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rapid Vision Loss Due to Multifocal Glioma: A Diagnostic Challenge.","authors":"Fletcher J Ng, Wendy Wang, Laveniya Satgunaseelan, Nitin Verma","doi":"10.1007/s40123-024-00922-1","DOIUrl":"10.1007/s40123-024-00922-1","url":null,"abstract":"<p><strong>Introduction: </strong>This is a unique case report in medical literature for its detailing of diagnostics of an uncommon presentation of a rapid unexplained bilateral vision loss of a 73-year-old male diabetic patient. This report highlights the crucial role of advanced molecular diagnostics in difficult neurological cases and also elucidates the difficulties involved in diagnosing optic nerve glioblastoma, an exceptionally rare and aggressive tumour.</p><p><strong>Main concerns and clinical findings of the patient: </strong>Slow and progressive loss of vision over 2 months, ultimately developing almost complete visual impairment in both eyes and a defect of right eye field of vision conclusively highlighted that the likely etiology was neuro-ophthalmic. Initially, the conditions were suspected to be an extended spectrum of diabetic eye disease complications but further deterioration was a hint towards something more substantive.</p><p><strong>Primary diagnoses, interventions and outcomes: </strong>This entailed in-depth diagnosis processes that included an MRI and the analysis of cerebrospinal fluid. The important discovery was through stereotactic biopsies of the optic nerve revealing a high-grade glial neoplasm. Next generation sequencing confirmed the pathology as IDH-wildtype glioblastoma. Despite management, his vision continued to deteriorate. Hence, an aggressive clinical course was followed.</p><p><strong>Conclusion: </strong>This case highlights the important learning need in considering glioblastoma of the optic chiasm as part of the differential diagnosis of rapid vision loss, which may present as multifocal brain lesions, especially in cases of rapid loss of vision where initial workup is negative. Quite a useful lesson that can be drawn from this case relates to the diagnostic process with advanced molecular profiling, more attention given to clinical suspicion and cutting-edge diagnostic tools applied in atypical presentation of neurological conditions.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11039432/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140158680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Short-Term Efficacy of Ophthalmic Cyclosporine: A 0.1% Cationic Emulsion in Dry Eye Patients Assessed Under Controlled Environment.","authors":"Laura Valencia-Nieto, José Pinto-Fraga, Marta Blanco-Vázquez, Itziar Fernández, Alberto López-Miguel, Carmen García-Vázquez, María J González-García, Amalia Enríquez-de-Salamanca, Margarita Calonge","doi":"10.1007/s40123-024-00906-1","DOIUrl":"10.1007/s40123-024-00906-1","url":null,"abstract":"<p><strong>Introduction: </strong>To evaluate the short-term efficacy of cyclosporine A (CsA)-0.1% cationic emulsion (CE) in patients with dry eye disease (DED) and mitigation of the inflammatory flares triggered by desiccating stress environments.</p><p><strong>Methods: </strong>A single-center non-randomized clinical trial was performed at a tertiary care setting. Twenty patients with DED treated with CsA 0.1% CE were exposed to a normal controlled environment (NCE) (23 °C, 50% relative humidity) and an adverse controlled environment (ACE) (23 °C, 10% relative humidity, 0.43 m/s localized airflow) during baseline and the 1- and 3-month visits. Patients underwent the following evaluations: conjunctival hyperemia and staining, corneal fluorescein staining (CFS) using the Oxford and Cornea and Contact Lens Research Unit (CCLRU) scale, meibomian gland (MG) secretion quality, Dry Eye Questionnaire-5, Symptom Assessment in Dry Eye (SANDE II), and Change in Dry Eye Symptoms Questionnaire. Multivariate models were adjusted for statistical analysis.</p><p><strong>Results: </strong>Nineteen women and one man (mean age, 58.9 ± 12.3 years) completed the study. All symptom questionnaires, CFS, conjunctival hyperemia and staining, and MG secretion quality improved (p ≤ 0.003) with 1 month of treatment; improvements were maintained after 3 months (p ≤ 0.02), except for SANDE II (p ≥ 0.07). The CFS worsening (total CCLRU) after baseline ACE exposure (from 8.6 to 10.1) was higher, although not significant (p = 0.64), compared with 1 month (from 5.4 to 5.8) and 3 months (from 5.0 to 5.9) after treatment.</p><p><strong>Conclusion: </strong>Topical CsA-0.1% CE improved DED signs and symptoms after 1 month of treatment under controlled environmental conditions. Future studies should confirm the benefit of CsA-0.1% CE in desiccating stress environments.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT04492878.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11039578/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140040089","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy, Safety and Immunogenicity of Sun's Ranibizumab Biosimilar in Neovascular Age-Related Macular Degeneration: A Phase 3, Double-Blind Comparative Study.","authors":"Asim K Ghosh, Usha S Nikumbh, Chaitanya K Shukla, Rohit S Laul, Abhishek Dixit, Santosh K Mahapatra, Sameera Nayak, Urmil M Shah, Sandeep Parwal, Narendran Venkatapathy, Natasha Radhakrishnan, Anup Kelgaonkar, Sandeep Saxena, Divyansh Mishra, Vivek Pravin Dave, Perwez Khan, Manojkumar R Saswade, Malli S Shantilal, Kim Ramasamy, Smitha Sreekanta, Mandodari Rajurkar, Maulik Doshi, Sapan Behera, Piyush Patel, Shilpi Dhawan, Lalit Lakhwani","doi":"10.1007/s40123-024-00883-5","DOIUrl":"10.1007/s40123-024-00883-5","url":null,"abstract":"<p><strong>Introduction: </strong>The study aimed to evaluate comparability in terms of efficacy, safety and immunogenicity of Sun's ranibizumab biosimilar with reference ranibizumab in patients with neovascular age-related macular degeneration (nAMD).</p><p><strong>Methods: </strong>This prospective, randomised, double-blind, two-group, parallel-arm, multicentre, phase 3 comparative study included patients with nAMD ≥ 50 years, randomised (in a 2:1 ratio) in a double-blind manner to receive 0.5 mg (0.05 mL) intravitreal injection of either Sun's ranibizumab or reference ranibizumab in the study eye every 4 weeks until week 16 (total of four doses).</p><p><strong>Results: </strong>Primary endpoint results demonstrated equivalence in the proportion of patients who lost fewer than 15 letters from baseline best-corrected visual acuity (BCVA) to the end of week 16 (99% of patients in Sun's ranibizumab and 100% in reference ranibizumab; p > 0.9999), with the proportional difference (90% confidence interval) at -1% (-2.51, +0.61) lying within a pre-specified equivalence margin. Visual acuity improved by 15 or more letters in 43% of Sun's ranibizumab group and 37% of the reference ranibizumab group (p = 0.4267). The mean increase in BCVA was 15.7 letters in Sun's ranibizumab group and 14.6 letters in the reference ranibizumab group (p < 0.001 within both groups and p = 0.5275 between groups). The mean change in central macular thickness was comparable between groups (p = 0.7946). Anti-ranibizumab antibodies were found in one patient of the reference ranibizumab group, while neutralising antibodies were not found in any patients. Both products were well tolerated.</p><p><strong>Conclusion: </strong>Sun's ranibizumab biosimilar is found to be therapeutically equivalent to reference ranibizumab in patients with nAMD. There were no additional safety or immunogenicity concerns.</p><p><strong>Trial registration: </strong>CTRI/2020/09/027629, registered on 07 September 2020.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11039601/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140294121","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Future of Checkpoint Inhibitors in Uveal Melanoma: A Narrative Review.","authors":"Jinyu Wang, Zehua Li, Hongbo Yin","doi":"10.1007/s40123-024-00913-2","DOIUrl":"10.1007/s40123-024-00913-2","url":null,"abstract":"<p><strong>Introduction: </strong>Immune checkpoint inhibitors have made tremendous progress over the last decade in the treatment of cutaneous melanoma, but their application in uveal melanoma treatment is less successful, owing in part to the immunological privilege of the eye and the liver, the most frequent site of metastasis. Nevertheless, the therapeutic outcomes reported currently are less pessimistic.</p><p><strong>Methods: </strong>In this review, we provide an overview of recent studies of immune checkpoint inhibitors in uveal melanoma and its metastasis and classify studies in this field into three groups: monotherapy of immune checkpoint inhibitors, dual-agent immune checkpoint inhibitors, and immune checkpoint inhibitors combined with other systemic or regional therapies.</p><p><strong>Results: </strong>Briefly, monotherapy with immune checkpoint inhibitors performed poorly. Dual-agent immune checkpoint inhibitors had slightly better outcomes than traditional treatments, especially in specific patient populations. As for the combination therapy, the combination with other systemic therapies did not show superiority over dual-agent immune checkpoint inhibitors, but combination with hepatic regional therapies was quite promising. Moreover, research on emerging checkpoints is currently limited to the stage of mechanistic studies.</p><p><strong>Conclusion: </strong>We propose that immune checkpoint inhibitors remain alternative treatments for patients with uveal melanoma, but factors such as cost-effectiveness should also be taken into account. The combination therapy with immune checkpoint inhibitors deserves to be further explored.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11039591/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140158681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}