QLT Inc and Novartis Ophthalmics announced that health authorities in Japan have approved Visudyne (verteporfin) for the treatment of the "wet" form of age- related macular degeneration (AMD), the leading cause of blindness in people over age 50.

Specifically, Visudyne has been approved for the orphan indication of AMD with all types of subfoveal choroidal neovascularization (CNV). Patients with this serious condition lose their ability to read, drive and recognise faces in a few months.

"The approval in Japan is a significant step in our efforts to expand the Visudyne franchise," said Paul Hastings, President and Chief Executive Officer of QLT Inc. "We will now focus our efforts on securing reimbursement to ensure that this treatment is available to the thousands of AMD patients in Japan who previously had no other option due to the lack of any effective means to treat this disease."

Approval was based on the results of a well-designed 12-month clinical study conducted in Japan, which confirmed the efficacy and safety profile of Visudyne as demonstrated in 3 large randomized controlled trials conducted 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 submission of a new drug application in Japan for Visudyne was made in April 2002. Visudyne was evaluated in Japan as a therapeutic drug for the wet form of AMD following its designation as an orphan drug in June 1997.

Visudyne therapy is a two-step procedure. Following intravenous administration, Visudyne is activated by a non-thermal laser light. The process is known as photodynamic therapy. Visudyne selectively targets abnormal blood vessels under the retina, resulting in a reduction in their growth, without affecting normal/healthy retina tissue. This, in turn, stops the leakage associated with wet AMD. However, it is important for patients to be diagnosed and treated early if they are to gain maximal benefit from treatment with Visudyne. In Japan, Carl Zeiss Co., Ltd., and Lumenis Japan, Ltd. have submitted approval applications for laser devices, which would be used in Visudyne therapy.