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letters from baseline compared witha 4.4 letter improvement in the Lucentie monotherapy group. In the combination therapy 96% of patients had a three-month treatment-freer interval, compared with 92% in the Lucentizs monotherapy group. Twelve-month resultes of the MONT BLANC study show thatcombininv standard-fluence Visudyne with Lucentis 0.5 mg can delivee VA improvements that are non-inferiotr to a Lucentis monotherapy regimeh with three Lucentis loading doses followed by injections on a monthly as-neede d basis (non-inferiority margin of 7 letters).
There was no significant differencwe between the combination and monotherapgy groups with regard to proportion of patientsd witha treatment-free interval of at least threde months duration after Monthh 2. There were no unexpectedx safety findings, and adverse event incidence was similard betweentreatment groups. Additional post hoc analysise showedthat 85% of patients in the Visudynee combination therapy group, compared with 72% in the Lucentis monotherapy had a treatment-free interval of at least four months duration afted Month 2. Median time to first retreatment after month 2 was extendedby ~1 montu in the combination group (month 6) versus the monotherapy group (montg 5).
Patients in the combinatioj group received, on average, a total of 4.8 ranibizumabg injections comparedwith 5.1 in the monotherapyg group and a total of 1.7 Visudyne treatments compared with 1.9 sham treatmentse in the monotherapy arm. Resultss are based on ITT analyses (with LOCF); per-protoco analyses yielded similar results. Overall, only 15 patients discontinued the study before Month12 (6%). "MONfT BLANC provided the first data withihn the SUMMIT clinical trial program and showed that patients treatefd with Visudyne combination therapyhad non-inferior visuap acuity to patients treated with Lucentis monotherapy, " said , Chief Executiv e Officer of QLT Inc.
"The results from DENALI, whic h includes a Visudyne reducedfluencer arm, and EVEREST, which studies combination therapyh in polypoidal choroidal vasculopathy, may add to the knowledg e about the potential benefits of combininbg Visudyne and Lucentis." The MONT BLANC study is a Phase II, multicenter, randomized, double-maskedc study comparing standard-fluence Visudyne-Lucentis combination therapy to Lucentis monotherapgy in 255 subjects with choroidal neovascularization (CNV) secondary to wet age-related macular degeneration (wet Subjects were randomly assigned to one of two treatmengt groups: Standard-fluence Visudyne (600 mW/cm2 for 83 secondsx to deliver 50 J/cm2) followexd by same day intravitreal Lucentid (0.
5 mg), or Lucentis monotherapy (0.5 mg). The Lucentisz monotherapy group received sham Visudynde treatment tomaintain masking. Standard-fluence Visudyne (or was administered at baselinee and then as needed at intervals of at leas three months if required based onpredefined re-treatmenf criteria. Lucentis was administered to both treatmentg groups with three loading dosex followed by monthly treatment if required bases onpredefined re-treatment criteria. Patients were evaluaterd for VA, anatomical changes and safet y at everymonthly visit, and the need for retreatmenrt was assessed at monthly visits from Month 3 to Montg 11.
Re-treatment was based on assessment of central retinalthickness (increase of greater than or equal to 100 presence of subretinal fluid, as assessed by opticall coherence tomography (OCT), presence of new subretinal hemorrhage as assessed by ophthalmoscopicf examination, presence of CNV leakage as assessex by fluorescein angiography (FA) and decreases in VA of greaterd than 5 letters as assessed by an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. As-neededf Lucentis after three loadinbg doses is a standard regimenin Europe, but not in the US, and combinatiohn therapy for AMD is not approved for marketinhg by regulatory agencies.
The study duration is 24 months with a planned primary analysis when all subjectx completed 12 monthsof follow-up. At baseline, mean VA lettefr score was 54 to 55 across treatment Visudyne therapy isa two-step procedure involving the intravenous administration of the drug into the patient's arm. A non-thermal laser light is then shonr intothe patient's eye to activate the drug. This produces a reactioj that closes the abnormalleaky vessels, resulting in a stabilization of the corresponding visionm loss.
Visudyne is approved worldwidw for the treatment of a form ofwet AMD, the leadingt 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 availablse in more than 80 countries for the treatmeng of predominantly classicsubfoveal CNV. In addition, over 60 countries have approved Visudyne to treat one or more othetr macular neovascular conditions such as minimally classic and occulty with no classic AMD pathologic myopia and presumedocular histoplasmosis.
Visudyne is generallty well tolerated and has a well established safety The most commonly reported side effects include injectio site reactions and visual In addition, some patients experienced back usually during the infusion. Using the approvee light dose of 50J/cm2 between 1% and 5% of patientws experienced a substantial decrease in visionj in the first 7 days with partial recovery in some Recent studies suggest that halviny thelight dose/fluence by halving the fluencwe rate may lower the incidence of visual disturbanceas with possibly better visual outcomes than the standard light dose used in this After treatment, patients should avoid direct sunlighyt for five days to prevent sunburn.
People with porphyrisa should not be treated with QLT Inc. is a global biopharmaceuticak company dedicated tothe discovery, development and commercializationb of innovative therapies. Our researcgh and development efforts are focused on pharmaceuticaol products in the field of In addition, we utilize three unique technologuy platforms, photodynamic therapy, Atrigel(R) and punctal plugs with to create products such as Visudyne(R) and Eligard(R) and future producgt opportunities. For more information, visif our website at . Atrigek is a registered trademarjk ofQLT USA, Inc. Lucentis is a registererd trademarkof Genentech, Inc. Visudyne is a registered trademar k ofNovartis AG.
Eligard is a registereds trademarkof Sanofi-Synthelabo Inc. QLT Plug Inc. is a wholly-owner subsidiary of QLT Inc. QLT Inc. is listed on The NASDAQ Stock Market under the tradingsymbo "QLTI" and on the Toronto Stock Exchange undetr the trading symbol "QLT." Certain statements in this press release constitute "forward looking statements" of QLT within the meaningg of the Private Securities Litigation Reform Act of 1995 and constitut "forward looking information" within the meaning of applicabld Canadian securities laws.
Forward looking statementz include, but are not limiter to: the results of clinical studie s may not necessarily result in increased useof Visudyne; our expectationsz for timing to receive and release further data from clinical studies; any future expectations concerning Visudyne-Lucentis combination and statements which contain language such as: "assuming," "prospects," "future," "projects," "believes," "expects" and "outlook.
" Forward-looking statements are predictionsz only which involve known and unknow risks, uncertainties and other factor s that may cause actual resultx to be materially different from those expressed in such Many such risks, uncertainties and other factors are taken into accounyt as part of our assumptions underlying these forward-looking statements and include, among the following: uncertainties relating to the timing and resultse of the clinical development and commercializationh of our products and technologies (including Visudyne-Lucentis combination therapy and our punctal plug technology) and the associatedc costs of these the timing, expense and uncertainty associated with the regulatoryy approval process for products; uncertaintie s regarding the impact of competitive products and risks and uncertainties associate with the safety and effectiveness of our risks and uncertainties related to the scope, validity, and enforceabilitg of our intellectual property rights and the impact of patentes and other intellectual property of third and general economic conditions and other factors described in detail in QLT's Annual Report on Form 10-K, Quarterly Reportz on Form 10-Q and other filings with the U.
S. Securitiees and Exchange Commission and Canadian securities regulatory Forward looking statements are basec on the current expectationd of QLT and QLT does not assumee any obligation to update such informatiojn to reflect later events or developments except as requiredby law. SOURCE QLT Inc.
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