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Visudyne approved for wet AMD in Japan

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Health authorities in Japan have approved a drug for use in photodynamic therapy for the treatment of wet age-related macular degeneration, according to a press release.

Specifically, Visudyne (verteporfin for injection) has been approved for the orphan indication of age-related macular degeneration (AMD) with all types of subfoveal choroidal neovascularization (CNV), according to a press release issued jointly by QLT and Novartis Ophthalmics, the drug’s developer and marketer. The two companies will now focus on securing reimbursement from the government for the approved treatments, according to Paul Hastings, president and chief executive officer of QLT.

According to the companies, approval was based on results of a 12-month study conducted in Japan that confirmed the efficacy and safety profile that Visudyne demonstrated in three similar large-scale studies in the rest of the world.

“In fact, approximately 2 patients out of 3 participating in this study either maintained or improved their vision as a result of Visudyne therapy,” the companies stated in their joint press release.

Novartis and QLT filed an application for marketing approval of the drug with Japanese authorities in April 2002. In June of 1997, Visudyne was designated an orphan drug by Japan’s Health Ministry. In Japan, both Carl Zeiss Meditec and Lumenis have submitted marketing applications for laser systems to be used in conjunction with Visudyne.

Visudyne is commercially available in more than 70 countries for the treatment of predominantly classic subfoveal CNV and in more than 40 countries for occult subfoveal CNV caused by AMD, according to the companies; Visudyne is also approved in more than 55 countries for the treatment of subfoveal CNV due to pathologic myopia.