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Study will investigate safety, efficacy of PFTA as adjunct to Visudyne therapy.
2004 JUL 1 - (NewsRx.com & NewsRx.net) -- QLT Inc. (QLTI) has entered into a cooperative research and development agreement (CRADA) with the National Eye Institute (NEI) to study the effects of preservative-free triamcinolone acetonide (PFTA) as an adjunct to Visudyne therapy in patients with wet age-related macular degeneration (AMD).
The study will enroll approximately 300 patients in a multi-center, randomized, prospective phase III clinical trial that will investigate the long-term safety and potential efficacy of PFTA in all wet AMD patients undergoing Visudyne therapy.
"This is a very exciting development for QLT and is a great fit with our efforts in identifying new opportunities for expanding Visudyne," said Paul Hastings, president and chief executive officer of QLT Inc. "We hope the results of combination therapy will lead to improved vision for the many people with AMD."
Under the terms of the CRADA, QLT will provide funding for the combination clinical trial and assume responsibility for manufacturing of PFTA and in return will gain the option to an exclusive license for certain rights to PFTA in combination with Visudyne therapy. The NEI will be responsible for the clinical trial with scientific input from a joint committee representing both QLT and the NEI.
Visudyne therapy is developed and commercialized through the alliance of QLT and Novartis Ophthalmics, the eye health unit of Novartis Pharma AG.
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Source: HighBeam Research, Study will investigate safety, efficacy of PFTA as adjunct to...