By Kim Coghill
QLT Inc.'s stock jumped about 35 percent Thursday following release of data indicating that Visudyne therapy is effective in reducing the risk of vision loss in wet age-related macular degeneration (AMD) patients with occult subfoveal choroidal neovascularization (CNV).
The good news came on the heels of Tuesday's announcement that QLT had received an FDA approvable letter to expand the use of Visudyne for treatment of predominantly classic subfoveal CNV caused by other macular conditions such as pathologic myopia and ocular histoplasmosis syndrome (OHS). (See BioWorld Today, Feb. 6, 2001.)
QLT, of Vancouver, British Columbia, is developing Visudyne in conjunction with partner Novartis Ophthalmics, of Altanta, the eye health unit of Novartis AG. Its stock (NASDAQ:QLTI) gained $9.187 Thursday to close at $35.125.
Visudyne (verteporfin for injection) therapy currently is approved for the treatment of predominantly classic subfoveal CNV caused by age-related AMD, the leading cause of blindness in people over the age of 50.
Visudyne therapy also has been approved for commercial use in 31 countries for the treatment of AMD.
No one representing QLT was available for comment, but the company released a statement saying occult patients represent a sizeable population for which no proven therapy exists and could represent a 50 percent increase in the number of patients who can benefit from Visudyne.
Robert Uhl, a research analyst with Leerink Swann & Co. in Boston, said the therapy seems to benefit patients who are 100 percent occult. "But no one really knows how many of those [patients] are out there," he said.
He estimated that indication could generate between $30 million and $50 million in annual U.S. sales for the 10,000 or so patients who may seek the treatment.
The Phase IIIb trial results disclosed Thursday show that Visudyne therapy probably prevents progression of occult CNV, Uhl said.
Visudyne is a two-step procedure that can be performed in a doctor's office. First, Visudyne is injected intravenously into the patient's arm. A nonthermal laser light is then shined into the patient's eye to activate the drug. Visudyne therapy uses a specially designed laser that produces the low-level, nonthermal 689nm light required to activate the drug.
Use of Visudyne in occult CNV patients is based on results from a multicenter Phase IIIb randomized, placebo-controlled study called the VIP (verteporfin in photodynamic therapy) trial in which most patients had lesions composed of occult subfoveal CNV without classic components.
A complete analysis of the results is under way, QLT said.
"These results represent a significant milestone in our efforts to expand the use of Visudyne so that most patients with wet AMD can one day benefit from Visudyne therapy," a statement released by Julia Levy, QLT's president and CEO, said. "We plan to consult with regulatory authorities to determine how best to proceed from a regulatory and clinical standpoint."
QLT's stock dropped 31 percent to close at $28.062 in December after the company announced slower-than-expected growth for Visudyne in AMD. Company officials at that time said the drug was still bound for blockbuster status, with projected sales of $500 million to $600 million in a peak year. Company officials said the product was expected to log $36 million to $38 million in fourth-quarter 2000 sales. (See BioWorld Today, Dec. 15, 2000.) n