By Karen Pihl-Carey

QLT PhotoTherapeutics Inc. and Ciba Vision said the last patient completed therapy in a 24-month clinical trial of Visudyne for patients with the wet form of age-related macular degeneration (AMD). And a peer-review medical journal published for the first time extensive results of Visudyne from its first year in clinical trials.

The results of a 12-month analysis of two Phase III clinical trials show the therapy, compared to placebo, reduced the risk of vision loss in patients with the wet form of AMD. They can be found in the October issue of Archives of Ophthalmology.

QLT and Ciba, which co-develop Visudyne (verteporfin for injection), are gearing up for a meeting with an FDA panel to discuss findings of the therapy. They filed a new drug application in August. (See BioWorld Today, Aug. 17, 1999, p. 1.)

Ken Galbraith, senior vice president and chief financial officer of QLT, said the journal's report supports the findings by the companies.

"The conclusion of the authors in the study clearly supports applications we made with the FDA to go for patients with predominately classic wet AMD," he told BioWorld Today.

The last patient completed the 24-month study in September. Results from the full study will be released sometime in the first half of 2000, Galbraith said.

The two 24-month randomized, double-blind clinical trials focused on 609 patients with choroidal neovascularization (CNV) lesions. During the first year, researchers found statistical significance when vision remained stable or improved for 61 percent of patients treated, meaning they lost less than three lines of vision on a standard eye chart. In contrast, only 46 percent of patients on placebo found the same result. (See BioWorld Today, Jan. 6, 1999, p. 1.)

QLT, of Vancouver, British Columbia, and Ciba Vision, of Atlanta, also have applied for marketing rights in Europe, Australia and New Zealand. Ciba, the eye care unit of Basel, Switzerland-based Novartis AG, plans to market the product worldwide, while QLT will manufacture it.

The companies will go before an FDA panel on Nov. 17 to present their findings.

"We've done this before three times and been successful three times. That will help us," Galbraith said. Once the panel makes its recommendation, the FDA has until mid-February to make a decision.

"In all probability, we will be launching the product in the first quarter of next year," Galbraith said.

In the studies, researchers observed benefits of Visudyne in changing visual acuity, which became more pronounced as time went on. However, some people experienced severe vision loss, meaning they lost at least six lines of vision on a standard eye chart.

In contrast sensitivity evaluations, Visudyne-treated eyes lost about 1.3 letters, as opposed to placebo-treated eyes, which lost 4.5 letters.

And the visual acuity benefit was enhanced in 243 patients whose lesions constituted predominantly classic CNV.

The therapy was well-tolerated with minimal side effects. Patients received the drug through intravenous injection. A non-thermal light was shone into their eyes to activate the drug.

"The safety profile of the product is extremely good for older people," Galbraith said. "It's an age-related disorder, so the higher the age group, the greater the incidence of the disease."

AMD is the leading cause of blindness in people over the age of 50. It is characterized by the formation of abnormal blood vessels that grow across the central part of the retina, called the macula. The vessels leak fluid and cause scar tissue, which destroys a person's central vision within two months to three years. Worldwide, about 500,000 new cases develop each year.

QLT and Ciba also are conducting more Phase III studies of Visudyne for earlier stage AMD and pathologic myopia.