Biotech Values

[DewDiligence]

Re: Visudyne

I’ve posted on this board ad nauseam that Visudyne’s best days are behind it (and have been criticized for saying this, even by such luminaries as thebusyant).

Visudyne’s new failure in occult AMD—which happens to be the largest of the three AMD subgroups—certainly won’t help. At least now investors will not have to listen to QLTI’s CEO, Paul Hastings, babble about how Visudyne really works in all subgroups.

p.s. NVS lucked out today (or did they?) by having the bad news hit just a few hours after their annual R&D presentation.

p.p.s. thebusyant: since you changed the layout of your site, it no longer works for me. The location on the screen where the search terms are supposed to go is obscured by other items. (I use extra-large fonts, but your site worked fine before.)

http://biz.yahoo.com/prnews/050920/to296.html?.v=12

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QLT announces 2 year results of Visudyne(R) in Occult (VIO) trial

Tuesday September 20, 5:00 pm ET

VANCOUVER, Sept. 20 /PRNewswire-FirstCall/ - QLT Inc. (NASDAQ: QLTI ) announced today that preliminary analysis of the intent to treat population of the Visudyne® in Occult (VIO) trial did not achieve the primary end point at the two year time point. VIO is part of a broader series of trials conducted with Visudyne in patients with predominantly occult CNV. Two earlier trials, VIP (Visudyne In Photodynamic Therapy) and VIM (Visudyne in Minimally Classic), have previously demonstrated evidence of efficacy in this patient population. The company is still conducting further analyses on relevant subgroups [LOL]. The results of the full efficacy and safety analyses together with the combined evidence from the three trials will be discussed in the upcoming meeting of the Data and Safety monitoring committee (DSMC) and in advisory boards.

The DSMC is an independent panel of experts who are not participating in the studies. The primary responsibility of the DSMC is to oversee the studies and safeguard the interests of current and future participants in this trial.

The VIO trial was a Phase III, multi-center double-masked randomized trial to determine if photodynamic therapy with Visudyne can reduce the risk of vision loss in wet age-related macular degeneration (AMD) patients with subfoveal occult with no classic choroidal neovascularization (CNV). Visudyne is marketed by Novartis Ophthalmics, a division of Novartis AG.
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