Samsung Bioepis said it confirmed its Lucentis (ingredient: ranibizumab) biosimilar, Byooviz, as an effective and valuable option for patients with neovascular age-related macular degeneration (nAMD) in phase 3 clinical trial.

The new study results will be presented at an online meeting hosted by the European Society of Retina Specialists (EURETINA 2021) through a poster session.

The company conducted a post-hoc and subgroup analysis of phase 3 clinical study of Byooviz, identifying the baseline factors associated with visual acuity and anatomical outcomes at both primary endpoints through week 52.

Researchers randomized 634 patients with the median age of 75 to receive 0.05 milliliter of either Byooviz or ranibizumab directly into the space in the back of their eyes. The studies' primary endpoints were to observe the changes from baseline in best-corrected visual acuity (BCVA) at the eighth week and adaptations in central subfield thickness (CST) at the fourth week, and the research team followed up through the 52nd week.

The company conducted a subgroup analysis based on associated baseline changes in week 52 from baseline for BCVA outcomes. The study demonstrated that the baseline age, BCVA, CST, and total lesion size were associated with visual acuity and anatomical outcomes when managing nAMD with Byooviz or Lucentis.

The result showed comparable treatment effects within each subgroup between Byooviz and reference ranibizumab across important baseline characteristics, supporting the previously reported primary and secondary outcomes.

"The posthoc analysis of the study presented at EURETINA 2021 demonstrates important baseline factors that determine efficacy outcomes of nAMD treatment," said Shin Dong-hoon, vice president and leader of the medical and lifecycle safety team at Samsung Bioepis. "Additional subgroup analysis showed that there was no difference between Byooviz and the reference product in week 52 and the results support similarity between Byooviz and ranibizumab, verifying Byooviz as an effective option for nAMD patients worldwide."

Byooviz recently won approval from the European Commission in August. The company plans to add the drug to its biosimilar portfolio and commercialize it through Biogen along with Benepali, Imraldi, and Flixabi, which now lead the anti-TNF biosimilar market in Europe.