EQS-News

Aflibercept Biosimilar Candidate FYB203 shows comparable efficacy to the reference product Eylea1 in Phase III Study

EQS-News: Formycon AG / Key word(s): Study results/Study Aflibercept Biosimilar Candidate FYB203 shows comparable efficacy to the reference product Eylea1 in Phase III Study 06.02.2023 / 07:30 CET/CEST The issuer is solely responsible for the content of this announcement. Press Release // February 6, 2023

Aflibercept Biosimilar Candidate FYB203 shows comparable efficacy to the reference product Eylea¹ in Phase III Study

• MAGELLAN-AMD study demonstrates the comparable efficacy of FYB203 to the reference product Eylea in patients with neovascular age-related macular degeneration (nAMD)
• Primary efficacy endpoint for submission to the U.S. Food and Drug Administration (FDA) achieved in global phase III study
• Second successful clinical development program in the field of ophthalmological biosimilars highlights Formycon’s strong position in this area

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today published positive preliminary efficacy and safety data from MAGELLAN-AMD Phase III clinical trial for FYB203, its proposed biosimilar to Eylea.

The FDA-specific interim analysis of the randomized, double-blind, multi-center phase III study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB203 and the reference medicine Eylea in patients with neovascular age-related macular degeneration (nAMD).

The primary endpoint of the comparative global Phase III trial measures the change in best corrected visual acuity after eight weeks from baseline. The values obtained for FYB203 and the reference product are within the relevant equivalence limits. In addition, to date, the study was conducted without any clinically relevant differences in terms of safety and immunogenicity.

Following the approval and market launch of the ophthalmological biosimilar for Lucentis (FYB201 marketed as Ongavia² (UK), Ranivisio³ (EU), and Cimerli^TM4 (US)), Formycon is now announcing, with FYB203, another successful development in the field of ophthalmology, thereby highlighting its strong position in this area.

Neovascular age-related macular degeneration (nAMD) is caused by the excessive growth of blood vessels in the retina. The active ingredient aflibercept inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina, which leads to a progressive loss of vision. In industrialized countries, AMD is the most common cause of severe visual impairment or blindness. According to estimates, up to 77 million Europeans will be affected by 2050.[i]