Interim results from a post-marketing surveillance study presented at the American Society of Retina Specialists (ASRS) annual meeting suggest that SB11 (Byooviz), a biosimilar referencing ranibizumab (Lucentis), demonstrated a safety profile comparable to the reference product while maintaining efficacy in both treatment-naïve patients and those switched from other anti-VEGF therapies.

The data were presented by Samsung Bioepis and Harrow during the meeting, held July 15-18 in Montréal, Canada.

The open-label, prospective, multicenter, observational phase 4 study evaluated the real-world safety and effectiveness of SB11 in patients with retinal diseases treated in the Republic of Korea. Initiated in May 2022 and completed in May 2026, the study enrolled 305 patients, with the interim analysis including data from 298 participants—182 treatment-naïve patients and 116 who had switched from another anti-VEGF therapy.

Patients were followed for up to 24 weeks after their first SB11 dose, with treatment intervals determined at the investigator's discretion to reflect routine clinical practice. Investigators assessed efficacy using best-corrected visual acuity (BCVA) and central subfield thickness (CST), while safety was evaluated through the incidence of adverse events.

Among treatment-naïve patients, mean BCVA improved by -0.10 (standard deviation [SD], 0.29), compared with -0.03 (SD, 0.24) in switched patients (P = 0.0239). Mean CST decreased by 95 µm (SD, 125) in treatment-naïve patients and 53 µm (SD, 108) in switched patients (P = 0.0168).

The investigators reported no statistically significant differences in BCVA (P=0.6312) or CST (P=0.1686) outcomes across different retinal disease indications. However, disease duration was significantly associated with both BCVA (P=0.0003) and CST (P=0.001), suggesting that earlier treatment may be associated with improved visual outcomes. No new safety signals were identified during the interim analysis.

"The interim results from this large-scale post-marketing surveillance study reinforce the comparable safety profile of SB11 to reference ranibizumab. Importantly, the study demonstrated clinically meaningful efficacy improvement in treatment-naïve patients while maintaining efficacy in those switched from other anti-VEGF therapies," Donghoon Shin, executive vice president and head of the Clinical Sciences Division at Samsung Bioepis, said in a company announcement. "At Samsung Bioepis, we are committed to generating robust real-world evidence that can support retinal specialists in making informed treatment decisions for their patients."

"We believe this post-marketing surveillance data further strengthens the clinical foundation supporting Byooviz, reinforcing the confidence retina specialists can have in this biosimilar option—both in treatment-naïve patients and those transitioning from other anti-VEGF therapies," said Mark L. Baum, CEO of Harrow. "We're grateful for our collaboration with Samsung Bioepis in generating this evidence, and we remain committed to giving physicians the data they need to prescribe with confidence."

The study, titled "Efficacy and Safety of SB11 in Treatment-Naïve and Switched Patients with Retinal Diseases: Interim Results from a Post-Marketing Surveillance Study," was presented as a paper-on-demand in the neovascular age-related macular degeneration category at ASRS 2026.