BRIEF—Kyowa Kirin gets Japanese approval for topical ophthalmic Mitomycin C agent

Japanese drugmaker Kyowa Kirin announced that Mitomycin C agent (mitomycin 2mg for ophthalmic topical use), licensed from India’s Intas Pharmaceuticals has been approved by Ministry of Health, Labor and Welfare (MHLW) for an adjunct to open glaucoma surgery in Japan.

The Japanese Ophthalmological Society has requested that the anticancer agents, Mitomycin C, which are marketed by Kyowa Kirin in Japan, can be used during surgery for glaucoma with ocular hypertension.

Additionally, the MHLW reported its opinion that Mitomycin C meets the “criteria for medical necessity” at the "Review Committee on Unapproved or Off-label Drugs with High Medical Need" held on May 29, 2019. Kyowa Kirin later received a request for development for this indication from the MHLW.

This approval is based on the application that Kyowa Kirin filed in January 2022 for manufacturing and marketing approval of Mitomycin C agent, as a topical ophthalmic agent.