Altos Subsidiary of Alteogen Reports the Completion of Patient Enrollment in P-III Clinical Trial of Eylea Biosimilar for Neovascular Age-related Macular Degeneration
Shots:
- 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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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
