Altos Biologics has completed patient enrolment in a global Phase 3 clinical trial of ALT-L9, an Eylea biosimilar for neovascular (wet) age-related macular degeneration (AMD).
The company intends to develop ALT-L9 for the same use as aflibercept with respect to route of administration, dosage, and therapeutic indications.
According to a news release1 issued by parent company, South Korean-based Alteogen Inc., the Phase 3 trial of ALT-L9 is a randomised, double-masked, parallel group, multicentre study. It will compare the efficacy and safety of ALT-L9 versus Eylea in 431 patients with wet AMD.
The company is aiming for an early 2024 Phase 3 completion and a product launch in Europe after obtaining approval in the first half of 2025, according to the release.
References
1. Alteogen Inc., Altos Biologics, a subsidiary of Alteogen, completed patient enrollment in global Phase 3 clinical trial of Eylea biosimilar in neovascular age-related macular degeneration (media release) 22 Feb 2023. www.prnewswire.com/news-releases/altos-biologics-a-subsidiary-of-alteogen-completed-patient-enrollment-in-global-phase-3-clinical-trial-of-eylea-biosimilar-in-neovascular-age-related-macular-degeneration-301752666.html [accessed 1 March 2023].
2. Alteogen Inc., Alteogen Announces Completion of Phase 1 Clinical Trial of Aflibercept Biosimilar in Wet AMD Patients (media release) 8 March 2021.
