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QLT announces 12-month results from Novartis sponsored MONT BLANC study evaluating standard-fluence Visudyne(R) combination therapy
Date:6/15/2009

ver 50 J/cm2) followed by same day intravitreal Lucentis (0.5 mg), or Lucentis monotherapy (0.5 mg). The Lucentis monotherapy group received sham Visudyne treatment to maintain masking. Standard-fluence Visudyne (or sham) was administered at baseline and then as needed at intervals of at least three months if required based on predefined re-treatment criteria. Lucentis was administered to both treatment groups with three loading doses followed by monthly treatment if required based on predefined re-treatment criteria. Patients were evaluated for VA, anatomical changes and safety at every monthly visit, and the need for retreatment was assessed at monthly visits from Month 3 to Month 11. Re-treatment was based on assessment of central retinal thickness (CRT) (increase of greater than or equal to 100 (micro)m), presence of subretinal fluid, as assessed by optical coherence tomography (OCT), presence of new subretinal hemorrhage as assessed by ophthalmoscopic examination, presence of CNV leakage as assessed by fluorescein angiography (FA) and decreases in VA of greater than 5 letters as assessed by an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. As-needed Lucentis after three loading doses is a standard regimen in Europe, but not in the US, and combination therapy for AMD is not approved for marketing by regulatory agencies. The study duration is 24 months with a planned primary analysis when all subjects completed 12 months of follow-up. At baseline, mean VA letter score was 54 to 55 across treatment groups.

About Visudyne

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 A
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SOURCE QLT Inc.
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