Efficacy of Ranibizumab Biosimilar in Treating Macular Neovascularization

In a groundbreaking study conducted at the Shantilal Shanghvi Eye Institute in Mumbai, India, researchers evaluated the efficacy of a newly approved ranibizumab biosimilar, Oceva® (Sun Pharmaceutical Industries Limited), in treating macular neovascularization (MNV) secondary to neovascular age-related macular degeneration (nAMD) and polypoidal choroidal vasculopathy (PCV). The retrospective analysis included thirty-six treatment-naïve eyes that received three loading doses of the biosimilar between September 2023 and December 2024.

The findings revealed significant improvements in best-corrected visual acuity (BCVA), with the mean BCVA improving from 0.94 ± 0.59 logMAR (approximately 20/174) to 0.84 ± 0.61 logMAR (approximately 20/138) at the 12-week mark (P=0.04). Moreover, en-face optical coherence tomography (OCT) demonstrated a marked reduction in median fluid area from 0.9 mm² (interquartile range [IQR] 0.62–4.56) to 0.32 mm² (IQR 0.1–0.64; P=0.007), and median fluid perimeter decreased significantly from 10.95 mm (IQR 7.26–25.67) to 6.02 mm (IQR 1.76–7.93; P=0.0005).

The reduction in the proportions of eyes with subretinal fluid (SRF), intraretinal fluid (IRF), and subretinal hyperreflective material (SHRM) was also notable, indicating the biosimilar's effectiveness in alleviating the symptoms associated with MNV. Specifically, the proportion of eyes with SRF dropped from 83.33% (30/36) at baseline to 58.33% (21/36) at 12 weeks (P=0.015), while IRF decreased from 66.67% (24/36) to 38.89% (14/36; P=0.013).

The study, led by Dr. Jay Umed Sheth, Faculty Ophthalmologist and Head of the Department of Retina Services, underscores the potential of Oceva® as a cost-effective alternative to traditional therapies for AMD, particularly important in regions like India where access to expensive treatments is often limited. The approval of Oceva® adds to the growing list of biosimilars designed to improve patient accessibility without compromising efficacy or safety.

As age-related macular degeneration continues to pose a significant public health challenge, with projections indicating nearly 288 million individuals affected globally by 2040, the introduction of more affordable treatment options is crucial. According to Dr. Ankit Kumar Bhopalka, a co-author of the study, "The results from our analysis illustrate not only the promising outcomes associated with the biosimilar but also the innovative application of en-face OCT-MI technique, which allows for a more detailed assessment of fluid dynamics in treating MNV."

Furthermore, the study highlights the importance of en-face OCT-MI as a quantitative biomarker for fluid exudation, paving the way for future research that may integrate advanced imaging technologies with biosimilar treatments. Given the lower cost profile of biosimilars, the adoption of Oceva® may significantly broaden access to effective therapy in resource-limited settings, ultimately shaping the future of MNV management and improving patient outcomes.

As regulatory bodies continue to approve biosimilars, including the FDA's recent endorsements, the retinal community is optimistic about the potential for these agents to transform treatment landscapes in ophthalmology. With ongoing studies needed to validate the long-term efficacy and safety of biosimilars such as Oceva®, the future outlook remains promising for those affected by MNV due to nAMD and PCV.