Alteogen said Friday it has completed phase 1 clinical trial of ALT-L9, a biosimilar of Regeneron’s Eylea that treats macular degeneration, for the first time in Korea. 

The company has also finished the registration of formulation patents in the U.S. and Europe and applied for production patent under the Patent Cooperation Treaty (PCT), completing the three-phase step to secure its global competitiveness, Alteogen said.

Alteogen conducted its first local clinical trial of the biosimilar at four hospitals -- Seoul Asan Medical Center, Samsung Seoul Hospital, Seoul National University Bundang Hospital, and Samsung Medical Center. The researchers randomly assigned 28 peoples with macular degeneration related to newborn vascularity age on the ratio of 1:1. Out of the 28 subjects, 14 were injected with Eylea, and the other group was given ALT-L9.

Alteogen said it has completed phase 1 clinical trials of ALT-L9, its biosimilar of Regeneron’s Eylea that treats macular degeneration, for the first time in Korea. (Alteogen)
Alteogen said it has completed phase 1 clinical trials of ALT-L9, its biosimilar of Regeneron’s Eylea that treats macular degeneration, for the first time in Korea. (Alteogen)

The test result showed that no drug-related adverse effects were observed in Eylea and ALT-L9. According to the company, the biosimilar also showed effects on improving best-corrected visual acuity (BCVA) and central subfield thickness (CST). 

The clinical trial was the first for a preemptive measure for a global P3 trial to confirm safety and efficacy in macular degeneration patients, the company said.

Eyelea is a treatment for chronic macular degeneration, one of the major senile eye diseases for losing eyesight, along with senile cataract and glaucoma. According to a report by Regeneron, it is difficult to develop, as the original developer has strictly registered patents for blockbuster drugs in the U.S. alone.

“It is relatively easier to enter the P1 and P2 trial due to Eylea’s biosimilar traits. Because of the original formulation patent, however, it is extremely difficult to launch products. Still, we have secured the P1 trial result for the biosimilar,” an Alteogen official said.
 

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