Alteogen said on the 15th it won domestic approval for the macular degeneration treatment "Izenpiju (ingredient Aflibercept)" from the Ministery of Food and Drug Safety.
Izenpiju is an Eylea biosimilar developed under the project name "ALT-L9." It received marketing authorization in Europe last year. The company plans to pursue a domestic launch based on this approval.
The approval was based on results from a global phase 3 clinical trial conducted in 12 countries, including Europe, Korea, and Japan, by subsidiary Alteogen Biologics. In the trial, ALT-L9 demonstrated therapeutic equivalence and safety compared with the original drug Eylea, the company said.
Alteogen Biologics is also developing a next-generation macular degeneration drug candidate, "ALTS-OP01." It is a new ophthalmology drug candidate aimed at improving efficacy and extending dosing intervals compared with existing therapies.
Alteogen is also conducting research on high-dose formulation technology. The company has filed a related international patent (PCT) and plans to strengthen its capabilities in developing follow-on ophthalmic therapies based on the clinical and regulatory experience gained from this project.