Samsung Bioepis will present the final of its phase 3 clinical trials of SB11, a Lucentis biosimilar, during the online conference of the American Academy of Ophthalmology (AAO) 2020 from Friday to Sunday.

The company enrolled 705 patients in the phase 3 study and analyzed the results of 634 who completed the study up to week 52.

“The study met its primary endpoints, defined as changes from baseline in best-corrected visual acuity (BCVA) at week eight and central subfield thickness (CST) at week four,” the company said. “Secondary endpoints, including long-term efficacy, safety, pharmacokinetics, and immunogenicity, were also comparable with Lucentis.”

The research result comes after the company presented its 24-week interim results from the Phase 3 study in May.

“The 52-week data confirms SB11 has an equivalence in efficacy and pharmacokinetics as well as a comparable safety and immunogenicity profile with the reference product,” said Kim Hee-kyung, senior vice president and clinical sciences division and regulatory affairs team leader at Samsung Bioepis. “The addition of this clinical data reinforces Samsung Bioepis’ ongoing commitment to bringing affordable treatment options to millions of patients with unmet medical needs.”

Lucentis is a treatment for eye diseases such as macular degeneration and diabetic macular edema sold by Roche and Novartis. Global sales for the drug amounted to about 4.6 trillion won ($3.9 billion) last year, and the substance patents for the treatment in Europe will expire in January 2022.

SB11 is the sixth biosimilar product and the first eye disease treatment that Samsung Bioepis developed after three autoimmune disease treatments -- SB2, SB4, SB5 -- and two anticancer treatments -- SB3, SB8.

The treatment candidate has also become the first biosimilar to go through the licensing process as a Lucentis biosimilar in the EU. The company plans to proceed with the approval process for marketing in the U.S. market in the future.