LophiBio Receives Approval for Phase 3 Clinical Trial Plan of Eylea Biosimilar in the US

Amicogen's affiliate, Rophibio, announced on the 11th that it has received approval from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for the Phase 3 clinical trial of RBS-001, a biosimilar of the ophthalmic treatment Ailria.

For this global clinical trial, Rophibio submitted the Phase 3 IND applications starting with Korea in December last year, followed by Europe in January, and the United States in February. Among these, the FDA, which was the last to receive the submission, was the first to approve the IND. The company explained, "this was the result of resolving issues regarding the Phase 3 plan in advance through the Type 2 Biologics Product Development (BPD) meeting held in January prior to the IND submission."

Rophibio expects sequential IND approvals in Korea and Europe within the second quarter following the U.S. approval. The planned completion date for the clinical trial is December next year. The study will compare the efficacy, safety, tolerability, and immunogenicity between RBS-001 and the original drug Ailria in patients with neovascular (wet) age-related macular degeneration.

Ailria is an ophthalmic treatment developed by Regeneron in the U.S. for wet macular degeneration and other eye diseases. It is a global blockbuster that recorded sales of $9.3806 billion (approximately KRW 12.79 trillion) last year. Macular degeneration is considered a leading cause of blindness. Abnormal growth of capillaries in the macula, the central part of the retina, causes blood leakage that adheres to the retina and obstructs vision. Therefore, treatments like Ailria, which inhibit new blood vessel growth, or similar mechanism antibody drugs such as Lucentis, must be administered regularly to suppress disease progression.

Since aging is a major cause, the incidence is rapidly increasing worldwide along with population aging. Global market research firm GlobalData forecasts that the market for macular degeneration treatments in the seven major countries (G7) including the U.S., France, and Germany will grow from $7.4 billion in 2021 to $27.5 billion (approximately KRW 37 trillion) by 2031.

Hong Seung-seo, CEO of Rophibio, said, “We anticipated a swift IND approval for Phase 3 due to the successful pre-IND meeting,” adding, “The U.S. accounts for more than 50% of the Ailria market, so this approval is expected to be a significant milestone in establishing our position in global biosimilar development, and we have high expectations.”