By Karen Pihl-Carey
About eight months after submitting a new drug application (NDA) for Visudyne to treat wet age-related macular degeneration (AMD), QLT PhotoTherapeutics Inc. and CIBA Vision Corp. received FDA approval for the light-activated therapy.
¿It¿s a tremendously exciting day for the company,¿ said Julia Levy, president and CEO of QLT. ¿But it¿s also a great day for patients with this disease because now there¿s hope for them.¿
Before Visudyne, there was no treatment available for patients with wet AMD, a condition in which abnormal blood vessels form under the central part of the retina, leaking fluid and causing scar tissue, which destroys central vision. It is the leading cause of blindness in people over the age of 50 in the Western world.
The FDA approved Visudyne to treat AMD in patients with predominantly classic subfoveal choroidal neovascularization (CNV). About 500,000 new patients worldwide develop wet AMD every year, and between 40 percent and 60 percent of them will develop predominantly classic lesions during the progression of their disease.
Levy said there are about 200,000 new cases a year of wet AMD in North America.
Analyst Kevin Tang, of Deutsche Banc Alex. Brown, of New York, projected Visudyne sales of $14 million in the second quarter and $91 million for all of 2000. Projections for future years are $286.6 million in 2001, $457.8 million in 2002 and $627 million in 2003.
¿We continue to believe that Visudyne will perform well both near and long term,¿ Tang said in a research note. The treatment, he said, ¿has the potential to drive QLT into substantial profitability beginning in 2001.¿
The company¿s stock (NASDAQ:QLTI) closed Thursday at $59.625, up $2.75.
Visudyne therapy already has been approved in Switzerland and Malta, and several approvals are pending in the European Union, Canada, Australia and other countries. Visudyne, however, is available under various expanded access programs in more than 25 countries.
QLT, of Vancouver, British Columbia, and Atlanta-based CIBA Vision, the eye care unit of Novartis AG, of Basel, Switzerland, co-developed Visudyne and will split profits 50-50. They also will share marketing costs, although CIBA is responsible for marketing of the product and QLT retains responsibility for manufacturing.
¿We heard about the approval and within an hour we already shipped our first shipment of Visudyne,¿ said Kristie Madara, spokesperson for CIBA Vision. ¿We just needed official approval that we could sell the product, and it was shipped.¿
Levy said an expanded access program enabled the companies to train physicians and distribute lasers so that 80 percent of retinal specialists already were trained and ready to perform the therapy. They had patients waiting for it, she said.
The therapy involves the injection of the drug verteporfin intravenously into the patient¿s arm. The drug selectively accumulates in the eye¿s abnormal blood vessels. A red non-thermal laser is shined into the patient¿s eye to activate the drug, and verteporfin then selectively affects the blood vessels, stopping their growth and vision loss. The lasers used in the therapy were developed by Coherent Inc., of Santa Clara, Calif., and Zeiss Humphrey, also of California.
¿This has been a long time coming,¿ Madara said, ¿and it¿s great to have a treatment for something that ophthalmologists have had to tell their patients, I¿m sorry, there¿s nothing I can do for you.¿¿
Madara said CIBA Vision will start marketing directly to consumers at the end of the second quarter.
The therapy also is being tested in other indications, Levy said.
In a Phase III, double-blinded, placebo-controlled study on patients with pathologic myopia, the therapy has shown excellent results, Levy said. The company intends to talk with the FDA about moving forward in that indication.
QLT also plans to start a clinical trial later this year to determine efficacy of the drug in diabetic retinopathy, or macular edema.
The FDA¿s approval of Visudyne for wet AMD is based on 12-month data from two 24-month randomized, double-masked, placebo-controlled Phase III trials. Findings of these trials showed that in 243 patients with predominantly classic CNV, vision remained stable or improved in 67 percent of patients treated with Visudyne therapy, compared to 39 percent of patients on placebo (p<.001).
Levy said QLT¿s interest in macular degeneration started around 1993.
¿We treated the first patient in December of 1995, so it¿s really a very, very short time from Phase I through the end of Phase III and approval,¿ she told BioWorld Today.