INCHEON, South Korea & NASHVILLE, Tenn., July 20, 2026
Samsung Bioepis Co., Ltd. and Harrow, Inc. have presented positive interim results from a large-scale Phase 4 post-marketing surveillance (PMS) study evaluating SB11 (BYOOVIZ®/AMELIVU®), a biosimilar to Lucentis® (ranibizumab), during the 44th Annual Meeting of the American Society of Retina Specialists (ASRS) 2026 in Montréal, Canada. The real-world observational study demonstrated that SB11 maintained a safety profile comparable to reference ranibizumab, while also delivering clinically meaningful improvements in visual function and retinal anatomy among treatment-naïve patients. In addition, patients who transitioned from other anti-VEGF therapies maintained stable outcomes after switching to SB11, providing ophthalmologists with additional real-world evidence supporting the biosimilar’s use across retinal diseases. The findings reinforce the growing clinical confidence in biosimilar ophthalmic therapies and highlight the importance of real-world evidence in expanding treatment access for patients with retinal disorders.
Large-Scale Real-World Study Confirms Safety and Effectiveness
The prospective, multicenter, open-label Phase 4 surveillance study enrolled 305 patients across the Republic of Korea to assess the real-world safety and efficacy of SB11 in individuals with retinal diseases. Interim analysis included 298 patients, consisting of 182 treatment-naïve participants and 116 patients switched from other anti-VEGF therapies. Clinical outcomes were measured using best-corrected visual acuity (BCVA) and central subfield thickness (CST), two established indicators of retinal function and disease progression. Results demonstrated statistically significant improvements in both visual acuity and retinal anatomy among treatment-naïve patients, while patients who switched therapies maintained stable clinical outcomes. Importantly, investigators reported no new safety concerns, confirming that the biosimilar continues to exhibit a safety profile comparable with the reference biologic in routine clinical practice. The findings provide valuable post-marketing evidence supporting physician confidence in prescribing SB11 for patients requiring anti-VEGF treatment.
Strengthening Clinical Confidence in Biosimilar Ophthalmic Therapies
Researchers emphasized that the study generated robust real-world evidence supporting the use of SB11 across multiple retinal diseases, including neovascular (wet) age-related macular degeneration (AMD), retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV). Investigators observed that earlier treatment was associated with improved visual outcomes, reinforcing the importance of timely intervention for patients with retinal disorders. Company representatives noted that the study strengthens the scientific foundation supporting BYOOVIZ® by demonstrating comparable safety alongside meaningful functional improvements in both newly treated and switched patients. The availability of large-scale post-marketing data is increasingly recognized as an essential component in validating biosimilar performance beyond regulatory approval, enabling retina specialists to make more informed treatment decisions while expanding access to cost-effective biologic therapies.
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Expanding Access Through Biosimilar Innovation
The interim results further underscore Samsung Bioepis’ commitment to advancing biosimilar development across ophthalmology and other therapeutic areas while highlighting Harrow’s focus on delivering comprehensive ophthalmic disease management solutions throughout North America. As healthcare systems continue to adopt biosimilars to improve affordability and broaden patient access, studies evaluating long-term safety and effectiveness in routine clinical settings have become increasingly important. The positive Phase 4 findings presented at ASRS 2026 strengthen the growing body of evidence supporting SB11 as a clinically reliable alternative to reference ranibizumab and reinforce the expanding role of biosimilars in retinal disease management. Continued collection of post-marketing evidence is expected to further support physician confidence, optimize treatment strategies, and improve access to advanced biologic therapies for patients with vision-threatening retinal diseases.
Source: Samsung Bioepis, Harrow Press release
