Samsung Bioepis and Harrow report ASRS 2026 interim real-world Phase IV data showing BYOOVIZ (SB11) maintained comparable safety and effectiveness to ranibizumab.
Written By: Umesh Hanumante,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
Samsung Bioepis and Harrow have announced encouraging interim results from a large real-world post-marketing surveillance (PMS) study evaluating SB11, marketed as BYOOVIZ® in the United States and AMELIVU® in South Korea, in patients with retinal diseases. The findings were presented at the 44th Annual Meeting of the American Society of Retina Specialists (ASRS) 2026 in Montréal, Canada.
The study showed that SB11, a biosimilar referencing Lucentis® (ranibizumab), demonstrated a safety profile comparable to the reference medicine while providing clinically meaningful improvements in visual acuity and retinal anatomy in treatment-naïve patients with retinal diseases. Patients who switched from other anti-VEGF therapies also maintained stable visual and anatomical outcomes, supporting the use of SB11 in routine clinical practice.
Real-World Study Evaluates SB11 in Routine Practice
The open-label, prospective, multicenter, Phase IV observational study was conducted in South Korea between May 2022 and May 2026 to evaluate the real-world safety and effectiveness of SB11. A total of 305 patients were enrolled, with the interim analysis including data from 298 patients, comprising 182 treatment-naïve patients and 116 patients who had switched from another anti-VEGF therapy.
Patients were followed for up to 24 weeks, with treatment intervals determined by treating physicians to reflect routine clinical practice. Efficacy was assessed using best-corrected visual acuity (BCVA) and central subfield thickness (CST), while safety was monitored through the incidence of adverse events.
Interim Results Show Visual and Anatomical Benefits
Treatment-naïve patients experienced clinically meaningful improvements in both vision and retinal anatomy. Mean BCVA improved by −0.10, while switched patients demonstrated a mean improvement of −0.03. Mean CST decreased by 95 μm in treatment-naïve patients and 53 μm in patients who switched from another anti-VEGF therapy.
Researchers also reported no statistically significant differences in BCVA or CST outcomes across different retinal disease indications, suggesting consistent performance of SB11 regardless of the underlying condition.
In contrast, disease duration was significantly associated with both BCVA and CST outcomes, indicating that earlier treatment initiation may lead to better visual and anatomical prognosis.
Comparable Safety Profile Maintained
No new safety concerns were identified during the interim analysis. The overall safety profile remained consistent with that of reference ranibizumab, further supporting previous analytical and clinical evidence demonstrating biosimilarity.
Samsung Bioepis and Harrow said the real-world findings further strengthen the clinical evidence supporting SB11 and provide retina specialists with additional confidence when prescribing the biosimilar for both newly diagnosed patients and those transitioning from other anti-VEGF therapies.
About BYOOVIZ®
BYOOVIZ® (ranibizumab-nuna) is a biosimilar of Lucentis® (ranibizumab), a vascular endothelial growth factor (VEGF) inhibitor used to treat several sight-threatening retinal diseases. In the United States, it is approved for neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV).
By inhibiting VEGF, BYOOVIZ® reduces abnormal blood vessel growth and vascular leakage, helping preserve vision in patients with retinal diseases.
What This Means to Patient
As biosimilars become increasingly integrated into ophthalmology, real-world evidence plays an important role in confirming their safety and effectiveness beyond controlled clinical trials. The interim PMS findings presented at ASRS 2026 add to the growing body of evidence supporting SB11 as a treatment option with a safety profile comparable to reference ranibizumab while maintaining consistent clinical performance in routine practice. The observed association between shorter disease duration and better outcomes also underscores the importance of early diagnosis and timely initiation of anti-VEGF therapy.
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About the Writer
Umesh Hanumante (M.Pharm) (LinkedIn) is a pharmacy professional and healthcare writer with a background in Regulatory Affairs, pharmaceutical innovation, and clinical research. He has around two years of industry experience as an Executive PMT at Troikaa Pharmaceuticals Ltd and qualified GPAT 2024. His areas of interest include regulatory compliance, dossier preparation, clinical trials, emerging therapies, and advancements in the global pharmaceutical and healthcare sector.