Mean visual acuity letter scores increased similarly in all treatment groups
VANCOUVER, Dec. 16 /PRNewswire-FirstCall/ - QLT Inc. (NASDAQ: QLTI; TSX: QLT) today announced six-month results from an interim analysis for the Phase II RADICAL study (Reduced Fluence Visudyne Anti-VEGF-Dexamethasone In Combination for AMD Lesions). The RADICAL study is a Phase II, multicenter, randomized, single-masked study comparing reduced-fluence Visudyne(R)-Lucentis(R) combination therapies (with or without dexamethasone) with Lucentis monotherapy in 162 subjects with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). The independent Data and Safety Monitoring Committee (DSMC) confirmed that there are no safety concerns at this time and recommended that the trial continue as planned. During this six-month interim period, mean visual acuity (VA) in each group increased from baseline and that increase appears to have been similar between groups. To date, the mean cumulative treatments were lower in the combination groups than in the Lucentis monotherapy group; however, it is too early to draw conclusions about comparative treatment frequencies, because this is influenced by the mandatory retreatments at month 1 and 2 in the Lucentis monotherapy group. The primary endpoint results at 12 months are expected in the first half of 2009.
In the RADICAL study, subjects were randomly assigned to one of four treatment groups: Group 1: Reduced-fluence Visudyne (300mW/cm2 for 83 seconds to deliver 25 J/cm2) followed within two hours by intravitreal Lucentis (0.5 mg) Group 2: Reduced-fluence Visudyne (300mW/cm2 for 83 seconds to deliver 25 J/cm2) followed within two hours by intravitreal Lucentis (0.5 mg) and then dexamethasone (0.5 mg) Group 3: Very low-fluence Visudyne (180mW/cm2 for 83 seconds to deliver 15 J/cm2) followed within two hours by intravitreal Lucentis (0.5 mg) and then dexamethasone (0.5 mg) Group 4: Lucentis monotherapy (0.5 mg), mandatory injection for initial treatment and the first two months and then PRN
The purpose of the study is to determine if combination therapy reduces retreatment rates compared with Lucentis monotherapy while maintaining similar vision outcomes and an acceptable safety profile. The study duration is 24 months with a planned primary analysis when all subjects complete 12 months of follow-up.
At baseline, mean best corrected visual acuity letter scores ranged from 58 to 53 across treatment groups. At six months, each group had similar mean visual acuity letter score improvements from baseline (Group 1: 4.0 letters; Group 2: 7.3 letters; Group 3: 2.5 letters; Group 4: 4.4 letters). Although cumulative retreatment rates were lower in all combination groups compared with the Lucentis monotherapy group, this was influenced by the mandatory retreatments at months 1 and 2 in the Lucentis monotherapy group. Longer-term follow up is needed to better compare the elective retreatment rates in each group.
"Determining if Visudyne therapy in combination with Lucentis with or without a steroid is a safe approach for a patient with the neovascular or wet form of AMD to maintain, if not improve visual acuity with fewer numbers of retreatments is an important question that this study will help to answer," said Henry Hudson, M.D., a lead investigator for the study. "If indicated by the one-year study results, less treatment frequency with similar vision and safety outcomes would be a positive outcome for patients, as it could mean fewer doctor visits. Based on the six-month data review for Visudyne combination therapy and the DSMC's recommendation, the study will continue as planned."
Visudyne therapy is a two-step procedure involving the intravenous administration of the drug into the patient's arm. A non-thermal laser light is then shone into the patient's eye to activate the drug. This produces a reaction that closes the abnormal leaky vessels, resulting in a stabilization of the corresponding vision loss.
Visudyne is approved worldwide for the treatment of a form of wet AMD, the leading cause of legal blindness in people over the age of 50, and has been used in more than two million treatments worldwide. Visudyne is commercially available in more than 80 countries for the treatment of predominantly classic subfoveal CNV. In addition, over 60 countries have approved Visudyne to treat other macular neovascular conditions such as minimally classic and occult with no classic AMD lesions, pathologic myopia and presumed ocular histoplasmosis.
Visudyne is generally well tolerated and has a well established safety profile. The most commonly reported side effects include injection site reactions and visual disturbances. In addition, some patients experienced back pain, usually during the infusion. Using the approved light dose of 50J/cm2 between 1% and 5% of patients experienced a substantial decrease in vision in the first 7 days with partial recovery in some patients. Recent studies suggest that halving the light dose/fluence may lower the incidence of visual disturbances with similar visual outcomes as the standard light dose which led to lower light doses being used in this study. After treatment, patients should avoid direct sunlight for five days to prevent sunburn. People with porphyria should not be treated with Visudyne.
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 field of ophthalmology. In addition, we utilize three unique technology platforms, photodynamic therapy, Atrigel(R) and punctal plugs with drugs, to create products such as Visudyne(R) and Eligard(R) and future product opportunities. For more information, visit our website at www.qltinc.com.
Atrigel is a registered trademark of QLT USA, Inc. Lucentis is a registered trademark of Genentech, Inc. Visudyne is a registered trademark of Novartis AG. Eligard is a registered trademark of Sanofi-Synthelabo Inc. QLT Plug Delivery, Inc. is a wholly-owned subsidiary of QLT Inc.
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 in this press release constitute "forward looking statements" of QLT within the meaning of the Private Securities Litigation Reform Act of 1995 and constitute "forward looking information" within the meaning of applicable Canadian securities laws. Forward looking statements include, but are not limited to: our expectations for timing to receive and release data from the RADICAL study; any future expectations about the reduced-fluence Visudyne-Lucentis combination therapy; and statements which contain language such as: "assuming," "prospects," "future," "projects," "believes," "expects" and "outlook." Forward-looking statements are predictions only which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed in such statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: the Company's future operating results are uncertain and likely to fluctuate; uncertainties relating to the timing and results of the clinical development and commercialization of our products and technologies (including reduced-fluence Visudyne-Lucentis combination therapy and our punctal plug technology) and the associated costs of these programs; the timing, expense and uncertainty associated with the regulatory approval process for products; uncertainties regarding the impact of competitive products and pricing; risks and uncertainties associated with the safety and effectiveness of our technology; risks and uncertainties related to the scope, validity, and enforceability of our intellectual property rights and the impact of patents and other intellectual property of third parties; and general economic conditions and other factors described in detail in QLT's 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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