Altos Subsidiary of Alteogen Reports the Completion of Patient Enrollment in P-III Clinical Trial of Eylea Biosimilar for Neovascular Age-related Macular Degeneration
- The company has completed the patient enrolment in an ongoing P-III trial evaluating the efficacy & safety of Eylea Biosimilar (ALT-L9) vs Eylea in 431 patients with neovascular AMD in 12 countries
- The study was based on the P-I study which showed similar safety & efficacy profiles to the originator product & evaluated PK characteristics. The product's competitiveness from an intellectual property standpoint is further enhanced by the filing & registration of formulation patents related to higher thermal stability & process patents enabling efficient drug substance manufacturing
- The company plans to complete the product approval in H1’25 while BLA will be submitted to the relevant health authorities in early 2024
Ref: PRNewswire | Image: Alteogen
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