The DJN report. Looking good...
Ian.
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Qlt Phototherapeutics Inc.
Dow Jones Newswires -- November 17, 1999
DJ FDA Panel Backs Visudyne From QLT, Novartis
By Otesa Middleton
WASHINGTON (Dow Jones)--A federal advisory panel recommended government approval of Visudyne, a light-activated treatment for the leading cause of blindness in older Americans.
Before Visudyne can be sold in the U.S. it needs the blessing of the Food and Drug Administration, which usually follows the advice of its panels. The agency is expected to make a decision early next year.
The panel supported the injected drug from QLT PhotoTherapeutics Inc. (QLTI) and Novartis AG's (Z.NOV) CIBA Vision for treating the wet form of age-related macular degeneration, which strikes 200,000 people in North America each year.
If Visudyne wins FDA approval, QLT will manufacture the product, while CIBA Vision will handle world-wide marketing.
Panelists said Visudyne should be approved because there are few treatment options available for this irreversible condition. Although most patients continued to lose sight after Visudyne treatment, those on the drug saw their eyesight deteriorate at a slower rate.
The companies' 12-month studies of Visudyne looked at 609 patients, with an average age of 75. Patients were randomly assigned to receive Visudyne or an inactive placebo intravenously.
The drug is light-activated. Fifteen minutes after the infusion starts, a light is shone into the eye for one minute and 30 seconds to make Visudyne start working. The drug then targets the abnormal blood vessels. If necessary, patients are treated again in three-month intervals for up to a year.
In the presentation to the panel, the companies said that 61% of patients on Visudyne had their vision stabilize - meaning that looking at a standard eye chart, they lost the ability to see fewer than three lines. Among those taking the placebo, 46% had their vision stabilize.
The company said the drug worked better on a group of patients whose eye lesions appeared mostly in the center of the retina, which is called predominantly classic subfoveal choroidal neovascularization. The study contained 243 such patients. In this subgroup, vision remained stable for 67% of patients compared to 39% on placebo. At the companies request, the FDA is considering approving the drug for that specific population.
The wet form of the disease, caused by leaking blood vessels in the central part of the retina, accounts for only 15% of all age-related macular degeneration but causes almost 90% of severe, irreversible vision loss associated with the condition. (The dry form is caused by deposits of drusen, a yellow material, on the retina.)
In early stages of the wet kind of the disorder, the first sign of vision loss is when straight lines look curved or distorted. This usually occurs in one eye, but half of patients will develop the condition in the other eye within five years.
In later stages, peripheral vision remains while the central eyesight disappears. Therefore, sufferers have a hole in the middle of images.
Dr. Wiley A. Chambers, the FDA's deputy director of anti-inflammatory, analgesic and ophthalmologic drug products, presented the FDA's assessment of the Visudyne data.
Chambers told the panel there was a clear difference between patients treated with Visudyne and those given the placebo.
However, he said the difference wasn't "clinically significant."
Patients with the classic lesions were more likely to benefit from treatment, Chambers said. Also, regardless of whether they are treated with Visudyne or placebo, women, younger people and patients with small lesions fare better overall.
Light Sensitivity Is Main Side Effect
The most common side effect was photosensitivity, an increased sensitivity to light that can lead to sunburn. A CIBA Vision spokesman said when patients are receiving the infusion, the company will show a video explaining importance of staying out of direct sunlight for three days. Patients will also get a hospital-like wristband that explains the photosensitivity.
Panelist Dr. George A. Cioffi, of the Devers Eye Institute in Portland, Ore., said Visudyne should be approved because "we don't have anything else right now."
Panel chairman Dr. Donald S. Fong, of Kaiser Permanente Medical Center's Department of Ophthalmology in Baldwin Park, Calif., said during the meeting that he was concerned that the improvement with Visudyne wasn't overwhelming.
"The benefit was small and it appears to be temporary," Fong said. "There is also not enough long-term data on the safety of the drug. We don't know the side effects of repeated treatment. How would the committee feel or how would patients feel if in two years, the benefits were completely reversed?"
After the meeting, Fong said Visudyne is "a step in the right direction."
"There are not a lot of things out there to treat this," Fong said. "This is probably the best thing, until the next thing comes along."
Dr. Neil M. Bressler, a Johns Hopkins University School of Medicine ophthalmology professor, presented data on behalf of the companies.
Although the companies only submitted one-year study data to the FDA, the two-year study has just been completed and will be given to the agency later, he said.
"There is nothing in the first 12 months that suggest it will result in reversal later," Bressler said.
-Otesa Middleton
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