Healthcare Industry News: sanofi-aventis
News Release - March 28, 2008
Positive results from Visudyne(R) combination therapy study reported at Annual Macula Society ConferenceVANCOUVER, March 28 (HSMN NewsFeed) - QLT Inc. (NASDAQ: QLTI ; TSX: QLT ) announced today that results from an investigator-sponsored Phase II study, in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD), showed that a combination therapy of verteporfin (Visudyne®) followed by bevacizumab (Avastin®) reduced, by half, the number of treatments required during the first six months to gain similar visual acuity compared to Avastin monotherapy. In addition, 30% of the patients treated using the combination therapy required only a single combination treatment compared to Avastin monotherapy, with which all patients required additional treatments.
Visudyne therapy is approved for the treatment of age-related macular degeneration (AMD) in patients with predominantly classic subfoveal choroidal neovascularization. QLT Inc. is the manufacturer of Visudyne.
Dr. Michael Potter, the investigator-sponsor of the verteporfin and bevacizumab (VIA) clinical trial, which was supported by QLT, presented results today at the 31st Annual Macula Society Meeting that is being held this week in Florida. The objective of the VIA study was to determine whether Visudyne, at low or very low fluence rates, in combination with Avastin, reduces the average number of treatments required, compared to Avastin alone.
"We are very pleased with the clinical outcomes of this study. Our goal was to see if it is possible to minimize the number of treatments while maintaining or improving visual acuity in patients with CNV secondary to AMD. At six months, virtually all the patients treated with the Visudyne combination therapy gained visual acuity with half the number of treatments required with Avastin monotherapy. These results are encouraging, and more research continues to be done to evaluate the benefits of combination therapy in terms of helping patients improve their vision and also reducing the cost of treatment," said Michael Potter, MD, FRCSC, Associate Professor, Department of Ophthalmology and Visual Sciences, Vancouver Hospital/University of British Columbia Eye Care Centre.
VIA Study Design
This study was a single centre, Phase II randomized, controlled, double-masked clinical trial involving 36 patients who were assigned to one of three treatment groups
Group 1: Low fluence Visudyne followed by Avastin
Group 2: Very low fluence Visudyne followed by Avastin
Group 3: Avastin alone
Intravitreal bevacizumab was delivered within two hours of PDT at baseline. Patients returned monthly thereafter for best-corrected ETDRS visual acuity (VA) testing, optical coherence tomography (OCT), and ocular examination. Retreatment decisions were based primarily on OCT. PDT was administered at months 0, 3, 4, 5 or 6, with a minimum 3-month interval between verteporfin/sham PDT treatments.
VIA Study Results
Thirty-five of 36 enrolled patients completed the 6-month visit. The average number of Avastin treatments in Group 3 was 5.1, compared to 2.8 in Group 1 and 2.4 in Group 2. Over 6 months, patients who were treated in the Group 1 and Group 2 required significantly fewer treatments on average than those treated in Group 3 (p=0.005 and p<0.001, respectively). Each group experienced an average improvement in visual acuity at month 6, compared to baseline (Group 1: 6.3 letters, p>0.05; Group 2: 14.1 letters, p=0.003; and Group 3: 10.8 letters, p<0.001, respectively). Both combination therapy and mono therapy used in the study were well tolerated.
Additional Study Results Reported on Visudyne Combination Therapy
Additional data demonstrating the potential benefits of Visudyne combination therapy were reported today at the Macula Society conference by: Dr. William F. Mieler, investigator and Chairman of the Registry Oversight Board Committee for QLT's two Visudyne registry studies (RVT001 and RVT002); Dr. Paolo Lanzetta, investigator for a triple therapy clinical study of ranibizumab, juxtascleral triamcinolone acetonide and Visudyne; and Dr. Albert Augustin, investigator of a triple therapy clinical study of Visudyne, dexamethasone and Avastin. Dr. Lanzetta's investigator-sponsored study was supported by Novartis AG and Dr. Albert Augustin's investigator-sponsored study was funded by QLT.
The abstracts for the studies can be found in the final conference program at: http://www.maculasociety.org/annualmeeting/final_program-08.pdf
QLT Inc. is a global biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies. Our research and development efforts are focused on pharmaceutical products in the fields of ophthalmology and dermatology. In addition, we utilize three unique technology platforms, photodynamic therapy, Atrigel® and punctal plugs with drugs, to create products such as Visudyne and Eligard® and future product opportunities. For more information, visit our web site at www.qltinc.com.
Atrigel is a registered trademark of QLT USA, Inc.
Visudyne is a registered trademark of Novartis AG.
Eligard is a registered trademark of sanofi-aventis.
QLT Inc. is listed on The NASDAQ Stock Market under the trading symbol "QLTI" and on The Toronto Stock Exchange under the trading symbol "QLT."
Certain statements contained in this press release, which are not historical facts, are "forward-looking statements," as the term is defined in the Private Securities Litigation Reform Act of 1995 and constitute "forward-looking information" within the meaning of applicable Canadian securities laws. Such forward-looking statements are predictions only and are subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors, which include, but are not limited to: the completion and results of studies on combination therapy, the level of physician acceptance of Visudyne in combination with other agents and the cost associated with such treatments is uncertain, and other factors as described in detail in QLT's Annual Information Form and Annual Report on Form 10-K, quarterly reports on Form 10-Q and other filings with the U.S. Securities and Exchange Commission and Canadian securities regulatory authorities. Forward-looking statements are based on the current expectations of QLT and QLT does not assume any obligation to update such information to reflect later events or developments except as required by law.
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