SANTA CLARA, Calif., Dec. 20 -- Coherent Inc. announced that the Swiss Regulatory Agency, Interkantonale Kontrollstelle für Heilmittel, has approved the marketing of Visudyne for treatment of the wet form of age-related macular degeneration (AMD). According to Coherent, the granting of a monitored release is common practice for new chemical entities in Switzerland; it requires that safety updates be submitted to the agency over a two-year period.
The action clears Coherent's Opal Photoactivator laser -- already CE-mark approved -- for use in treating patients with the disease. In addition, the approval will allow Coherent to apply for free marketing certificates, which in turn will enable approval in a number of other countries.
The Swiss agency concluded that Visudyne therapy with the laser treatment was most appropriate for patients with predominantly classic, subfoveal choroidal neovascularization; this indication was proposed by the treatment's co-developers, CIBA Vision Corp. -- the eye-care unit of Novartis -- and QLT PhotoTherapeutics Inc.