This study aims to investigate efficacy and safety of ranibizumab biosimilars (Amelivu® and LucenBS®) across retinal diseases in Korean clinical practice. This retrospective, multicenter study enrolled 1153 eyes from 1075 patients across five centers in South Korea between May 2022 and October 2024. Patients received intravitreal ranibizumab biosimilars for neovascular age-related macular degeneration, retinal vein occlusion with macular edema, diabetic macular edema, and other retinal diseases. Treatment-naïve eyes comprised 408 cases (35.4
Anti-vascular endothelial growth factor (VEGF) biologics have revolutionized the management of VEGF-driven retinal diseases, significantly improving visual outcomes for patients. Following the patent expiration of ranibizumab, multiple anti-VEGF biosimilars have been developed, with the first approved for ophthalmic use entering the market in 2022. More recently, the expiration of aflibercept market exclusivity in 2024 has led to the rapid development of aflibercept biosimilars-some already approved and others pending regulatory decisions. By offering clinically equivalent and cost-effective alternatives to reference biologics, biosimilars can lessen financial burdens and improve treatment adherence. Understanding the study designs of biosimilars can mitigate negative perceptions of biosimilars and promote their active implementation. In this review, we provide a comprehensive comparison of the designs of phase III clinical trials of aflibercept biosimilars, including recently published results.
Introduction:We report a case of spontaneous closure after early reopening of a previously successfully treated macular hole (MH). Case Presentation:A 73-year-old patient presented with visual acuity of 20/100 and complained of defective vision. Examination and investigations confirmed a full-thickness MH. Surgical intervention led to complete closure of the hole on OCT within 5 days. However, the patient reported recurrence of symptoms 2 weeks later, and reopening of the hole was diagnosed. Re-surgery was advised, but surprisingly, the hole spontaneously closed by the seventh week and remained closed at the last follow-up (6 months post-surgery), with visual acuity improving to 20/50. Conclusions:Reopening of an MH can occur months or years after successful treatment, and the underlying reasons remain unclear. While reoperation is often indicated, spontaneous healing, although rare, is possible. This case highlights the potential for spontaneous closure of a reopened MH, suggesting that a wait-and-watch approach may be worthwhile before deciding on further surgery.
BACKGROUND:To evaluate early real-world clinical outcomes on the safety and efficacy of the ranibizumab biosimilar (Oceva, Sun Pharmaceuticals, India). RESEARCH DESIGN AND METHODS:A multicenter, retrospective, uncontrolled observational study evaluating data from 404 eyes that received a total of 742 intravitreal injections of the ranibizumab biosimilar (Oceva 0.5 mg) across four centers in India, administered between August 2024 and May 2025 in variable approved and off label indications. Of the total eyes, 288 were treatment-naïve naïve, while 116 eyes were previously treated. RESULTS:The mean (SD) follow-up was 14.39 ± 12.5 weeks. The mean BCVA improved significantly from 0.87 to 0.59 LogMAR (p < 0.0001; d = 0.61), and mean CFT reduced from 406.8 µm to 306.5 µm (p < 0.0001; d = 0.66). Naïve eyes showed greater improvements than previously treated ones. No serious ocular or systemic adverse events were observed. CONCLUSIONS:The preliminary real-world data from this limited early series suggest that ranibizumab biosimilar (Oceva) appears to be efficacious and safe across the approved indications. However, long-term data with a larger population are needed to further strengthen the findings of this study.
