Ed,
a little more on the faint praise.
somehow, it still strikes me as quite positive for QLT during the next few years even if Barrett's treatment doesn't come to pass.
FWIW,
Ian.
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Medical Expert Says QLT/Ciba Treatment Will Face Rivals
By Tamsin Carlisle
(This story was originally published earlier Friday.)
VANCOUVER (Dow Jones)--A medical expert assessing the potentia, impact of a new therapy developed by QLT Phototherapeutics Inc. (QLTI) and Ciba Vision Corp. for age-related macular degeneration, or AMD, a disorder causing blindness, has concluded that the treatment represents an important step forward but that it won't be the only tool that physicians ultimately will use to keep the disease at bay.
Stuart L. Fine, a University of Pennsylvania ophthalmologist who has served as a member of an external group advising Ciba on policy, also expressed reservations about whether the therapy should be used to treat patients with occult choroidal neovascularization, or CNV, a less aggressive form of AMD than the one for which QLT and Ciba currently are seeking marketing approval for their product to treat.
Verteporfin photodynamic therapy, which QLT and Ciba Vision plan to market early next year under the trade-name Visudyne, is "an important new addition to the therapeutic armamentarium against neovascular AMD," Fine wrote in an editorial in the October issue of Archives of Ophthalmology, which also includes a peer-reviewed article reporting largely positive results from Phase III clinical trials involving Visudyne.
Fine said he plans to use the therapy in his own practice to treat AMD patients with "classic CNV" symptoms.
Kenneth Galbraith, QLT's chief financial officer, said in an interview that the vision of classic CNV patients tends to deteriorate more quickly than those of patients with occult CNV and that occult CNV can progress to classic CNV. He said there is a physiological difference in the degree of damage to blood vessels in the eyes of patients with the two different types of AMD, who can be distinguished from each other by means of a laboratory test.
Galbraith said QLT and Ciba decided not to wait for complete results from an extended clinical study designed, in part, to determine whether Visudyne therapy can benefit occult CNV patients as well a classic CNV patients. Instead, he said, they decided to apply on the basis of interim results from the study for marketing clearance for Visudyne to treat classic CNV patients. It is these patients who are the group at most immediate risk of serious vision loss progressing to blindness, Galbraith added.
"We think there is a tremendous benefit for patients right now," he said.
As reported in the ophthalmology journal, the 12-month results from ongoing 24-month clinical trials of Visudyne indicate that the treatment helps slow vision-loss in AMD patients with classic CNV. The 12-month results show no significant difference in the vision-loss suffered by a group of occult CNV patients treated with Visudyne and a comparable group given a dummy treatment.
Galbraith said he didn't find the results surprising because he would expect a treatment effect from Visudyne to show up first among patients whose vision could be expected to deteriorate the fastest if their diseases symptoms were left untreated. He said that 24-month results from the ongoing clinical trials should be available by the middle of next year.
Fine said the Visudyne clinical trials were carefully designed and that adverse effects from the treatment "seem to be minimal." He questioned whether physicians should recommend Visudyne treatment for occult CNV patients at this time not because of concerns that the treatment might be harmful but because of public health issues related to treatment cost and logistics.
Fine also noted that other potential treatments are being developed for AMD, including new surgical techniques and a radiation therapy. Eventually, to have "a major effect on reducing the extent of severe vision loss in patients with AMD", the disease must be attacked at an earlier stage than indicated for Visudyne therapy, he added.
Galbraith said the prospect of alternative treatments for AMD being available five years from now doesn't concern patients whose sight is failing now.
However, he said he considers Fine's editorial to be a fair overall assessment of Visudyne's potential contribution to the treatment of AMD.
"I think he does a really good job here," Galbraith commented.
QLT's stock plunged $6.563, or nearly 15%, Thursday on the Nasdaq Stock Exchange to close at $37.50 as investors and analysts pondered the implications of the study results for a November 17 review of Visudyne by a key advisory panel to the U.S. Food and Drug Administration.
QLT is a Vancouver pharmaceutical development company. Ciba is a unit of Swiss pharmaceutical company Novartis AG (Z.NOV).
-Tamsin Carlisle
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