Samsung Bioepis Announces Results From Post-Hoc Analysis of Phase 3 Study of Ranibizumab Biosimilar Byooviz

Samsung Bioepis announced results from a post-hoc and subgroup analysis of phase 3 clinical study of Byooviz (ranibizumab biosimilar) identifying the baseline factors associated with visual acuity and anatomical outcomes at both primary endpoints through week 52. The study results will be presented at the EURETINA 2021 Virtual Congress as an e-poster with voice recording.

“This post-hoc analysis of a phase 3 study presented at EURETINA Byooviz 2021 demonstrates important baseline factors that determine efficacy outcomes of nAMD treatment,” said Donghoon Shin, Vice President and Medical and Lifecycle Safety Team Leader at Samsung Bioepis. “Additional subgroup analysis showed that there was no difference between Byooviz and the reference ranibizumab in week 52 visual outcomes in many different subgroups, and this result further supports biosimilarity between Byooviz and reference ranibizumab. This goes to show that Byooviz is an effective and a valuable treatment option for nAMD patients worldwide”.

In the study, a total of 634 patients whose median (min, max) age was 75 (51, 96) years, were randomized to receive monthly 0.05 mL intravitreal injections of either 0.5 mg Byooviz or 0.5 mg reference ranibizumab. The primary endpoints were change from baseline in best corrected visual acuity (BCVA) at week 8 and change in central subfield thickness (CST) at week 4 with both endpoints then followed through week 52. Associations between baseline factors and treatment responses of BCVA and CST at week 52 were assessed by linear regression analyses, then multivariable analysis on baseline factors that were identified to have a pre-specified P value of <0.001.

Additionally, a subgroup analysis based on associated baseline factors was conducted on week 52 change from baseline for BCVA outcomes. The study demonstrated that the baseline age, BCVA, CST, and total lesion size were identified to be associated with visual acuity and anatomical outcomes when managing nAMD with Byooviz or reference ranibizumab. The similar visual outcomes of the two products in the change from baseline in BCVA in many different subgroups further support the equivalent clinical efficacy.

The details of the study are available on EURETINA 2021 virtual website here.

Byooviz has been approved by the European Commission as of August 2021.