March 14, 2003
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Visudyne efficacy studied

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DULUTH, Ga. — New study results from the Visudyne in Minimally Classic (VIM) Trial suggest that Visudyne therapy may be effective in patients with minimally classic wet age-related macular degeneration. Visudyne, developed by Novartis AG, is currently approved for other forms of wet AMD. Preliminary data from the VIM Trial showed that the mean change in visual acuity scores of patients in both Visudyne treatment arms (loss of 1.6 letters in the reduced fluence group and loss of 2.8 letters in the standard fluence group) were statistically significantly better than the loss of 9.4 mean letter change in patients receiving placebo. The VIM Trial is a multicenter study comprising 117 patients equally randomized to one of three treatment arms: placebo, Visudyne standard regimen or Visudyne reduced light intensity. In addition, results from exploratory analyses of the Treatment of AMD in Photodynamic therapy (TAP) Investigations and the Verteporfin in Photodynamic Therapy (VIP) Trial suggested the need to treat patients when lesions are relatively small in order to maximize vision benefits. Results show lesion size is an important predictor of Visudyne treatment benefit in occult with no classic and minimally classic lesions. In these groups, smaller lesions seemed to have better visual acuity outcomes, approximately 2 lines in favor of Visudyne-treated patients, showing similar treatment outcomes as with predominantly classic lesions.