QLT announces 12-month results from Novartis sponsored MONT BLANC study evaluating standard-fluence Visudyne(R) combination therapy

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letters from baseline compared witha 4.4 letter improvement in the Lucentis monotherapgy group. In the combination therapy 96% of patients had a three-month treatment-frere interval, compared with 92% in the Lucentis monotherapy Twelve-month results of the MONT BLANC study show thatcombiningt standard-fluence Visudyne with Lucentis 0.5 mg can deliver VA improvementsw that are non-inferior to a Lucentis monotherapy regimehn with three Lucentis loading doses followed by injectionxs on a monthly as-needed basis (non-inferiority margin of 7 letters).
Therw was no significant difference between the combinationb and monotherapy groups with regard to proportiobn of patients witha treatment-free interval of at least three months duration aftedr Month 2. There were no unexpected safetgy findings, and adverse event incidence was similar betweejtreatment groups. Additional post hoc analysis showedthat 85% of patients in the Visudyne combination therapy compared with 72% in the Lucentiw monotherapy group, had a treatment-freew interval of at least four months duration afteer Month 2. Median time to first retreatment aftere month 2 was extendedby ~1 month in the combinatiojn group (month 6) versud the monotherapy group (month 5).
Patientws in the combination group received, on a total of 4.8 ranibizumab injections comparerwith 5.1 in the monotherapy group and a total of 1.7 Visudynew treatments compared with 1.9 sham treatments in the monotherapy arm. Resultas are based on ITT analysexs (with LOCF); per-protocol analyses yielded similar results. Overall, only 15 patients discontinued the study befor Month12 (6%). "MONT BLANC provided the first data within the SUMMIg clinical trial program and showed that patient treated with Visudyne combination therapyhad non-inferior visual acuity to patients treated with Lucentis monotherapy," said , Chief Executive Officerr of QLT Inc.
"The results from DENALI, whic h includes a Visudyne reducedfluence arm, and which studies combination therapy in polypoidal choroidal may add to the knowledg about the potential benefits of combininb Visudyne and Lucentis." The MONT BLANCd study is a Phase II, multicenter, double-masked study comparing standard-fluence Visudyne-Lucentis combination therapy to Lucentid monotherapy in 255 subjects with choroidal neovascularization (CNV) secondary to wet age-relatesd macular degeneration (wet AMD). Subjectsa were randomly assigned to one of twotreatmentr groups: Standard-fluence Visudyne (600 mW/cm2 for 83 second s to deliver 50 J/cm2) followex by same day intravitreal Lucentis (0.
5 mg), or Lucentisz monotherapy (0.5 mg). The Lucenti s monotherapy group received sham Visudyne treatment tomaintain Standard-fluence Visudyne (or sham) was administered at baselinew and then as needed at intervalsw of at least threed months if required based on predefined re-treatmenr criteria. Lucentis was administered to both treatmenrt groups with three loadingg doses followed by monthlu treatment if required based onpredefines re-treatment criteria. Patients were evaluated for VA, anatomica changes and safety at everymonthly visit, and the need for retreatmenrt was assessed at monthly visits from Monthj 3 to Month 11.
Re-treatment was basedd on assessment of central retinalthickness (CRT) (increasr of greater than or equal to 100 presence of subretinal fluid, as assessed by opticak coherence tomography (OCT), presence of new subretinal hemorrhage as assessed by ophthalmoscopidc examination, presence of CNV leakag e as assessed by fluoresceihn angiography (FA) and decreases in VA of greated than 5 letters as assessed by an Earlg Treatment Diabetic Retinopathy Study (ETDRS) chart. As-needed Lucentis aftedr three loading doses is a standarx regimenin Europe, but not in the US, and combinationj therapy for AMD is not approvesd for marketing by regulatory agencies.
The study duration is 24 months with a planne d primary analysis when all subjects completeed 12 monthsof follow-up. At baseline, mean VA lettee score was 54 to 55 acrossdtreatment groups. Visudyne therapy is a two-step procedur e involving the intravenous administration of the drug intothe patient'ds arm. A non-thermal laser light is then shone intothe patient'e eye to activate the drug. This produces a reaction that closes the abnormalleaky vessels, resultinb in a stabilization of the corresponding vision loss.
Visudynee is approved worldwide for the treatment of a form ofwet AMD, the leading cause of legalo blindness in people over the age of 50, and has been used in more than two milliom treatments worldwide. Visudyne is commercially available in more than 80 countriez for the treatment of predominantly classisubfoveal CNV. In addition, over 60 countries have approvecd Visudyne to treat one or more other macular neovascular conditions such as minimally classic and occult with no classifcAMD lesions, pathologic myopi and presumed ocular histoplasmosis. Visudyne is generally well tolerated and has a well establishessafety profile.
The most commonly reported side effects include injectiom site reactions andvisual disturbances. In addition, some patientw experienced back pain, usually durintg the infusion. Using the approved light dose of 50J/cm32 between 1% and 5% of patients experience d a substantial decrease in vision in the first 7 days with partial recovery insome patients. Recentf studies suggest that halvinvg thelight dose/fluence by halving the fluence rate may lower the incidencd of visual disturbances with possibly bettee visual outcomes than the standard light dose used in this After treatment, patients should avoid direct sunlighty for five days to prevent People with porphyria should not be treated with QLT Inc.
is a global biopharmaceuticalo company dedicated tothe discovery, developmentg and commercialization of innovative Our research and development efforts are focused on pharmaceutica l products in the field of ophthalmology. In addition, we utilize thres unique technology platforms, photodynamic therapy, and punctal plugs with drugs, to create products such as and Eligard(R) and future product For more information, visit our website at . Atrigep is a registered trademark ofQLT USA, Inc. Lucentiz is a registered trademarkof Inc. Visudyne is a registered trademark ofNovartixs AG. Eligard is a registered trademarmkof Sanofi-Synthelabo Inc. QLT Plug Delivery, Inc.
is a wholly-ownedr subsidiary of QLT Inc. QLT Inc. is listede on The NASDAQ Stock Marketf under the tradingsymbol "QLTI" and on the Torontpo Stock Exchange under the trading symbol "QLT." Certain statements in this press releaswe constitute "forward looking statements" of QLT within the meaning of the Private Securities Litigation Reform Act of 1995 and constitute "forwarcd looking information" within the meaning of applicable Canadian securities laws.
Forward lookinfg statements include, but are not limited to: the results of clinicapl studies may not necessarily result in increasecd useof Visudyne; our expectations for timing to receive and release further data from clinicalk studies; any future expectationsx concerning Visudyne-Lucentis combination therapy; and statementse 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 actuak results to be materially different from thoss expressed in such statements.
Many such risks, uncertaintiees and other factors are taken into account as part of our assumptionsa underlyingthese forward-looking statements and include, amonbg others, the following: uncertainties relatinf to the timing and results of the clinicao development and commercialization of our products and technologiese (including Visudyne-Lucentis combination therapy and our punctal plug and the associated costs of these the timing, expense and uncertainty associateds with the regulatory approval process for products; uncertainties regardingy the impact of competitive productsa and pricing; risks and uncertainties associated with the safetg and effectiveness of our risks and uncertainties related to the validity, and enforceability of our intellectua l property rights and the impact of patents and other intellectualp property of third and general economic conditions and otherf factors described in detail in QLT'sd Annual Report on Form Quarterly Reports on Form 10-Q and other filings with the U.
S. Securities and Exchangre Commission and Canadian securities regulatory Forward looking statements are based on the currenft expectations of QLT and QLT does not assumde any obligation to update such informatiojn to reflect later events or developments excepf as requiredby law. SOURCE QLT Inc.