Visudyne

On January 29, 2004, U.S. health authorities expanded patient reimbursement for QLT’s Visudyne therapy to treat Wet Age Related Macular Degeneration (AMD). The changes, which could take effect by October 2004, will make 40,000 to 60,000 new patients eligible for reimbursement, potentially doubling QLT’s current patient pool of about 60,000. Until now, Medicaid has covered patients with classic age-related macular degeneration, but it will now also include those with the so-called occult and minimally classic forms of the disease, a leading cause of blindness in people over 50.

Wet AMD is a disease that causes a loss of central vision. It is caused by choroidal neovascularization (CNV), a growth of abnormal blood vessels under the central part of the retina, or the macula. These vessels leak fluid and cause scar tissue that attacks central vision, resulting in a deterioration of sight over a period that can range from a few months to three years. About 500,000 people are diagnosed with the eye disease each year, with 400,000 of those in the United States and Europe. Of those, 125,000 are classic, 175,000 are minimally classic and 200,000 have the occult form of the disease.

Visudyne therapy is a two-step procedure. Following intravenous administration, Visudyne is activated by a non-thermal laser light directed at the eye. This process is known as photodynamic therapy. Visudyne selectively targets abnormal blood vessels under the retina, resulting in a reduction in their growth, without affecting normal/healthy retina tissue. This in turn stops the leakage associated with wet AMD. Together with its partner Novartis, QLT reported Visudyne sales of $357 million dollars for the year ended Dec 31, 2003. Wall Street analysts have projected earnings in the $500 million dollar range for 2004. There are currently no competing, approved, photodynamic therapies for the treatment of wet AMD. In November 2003, a competing treatment showed “no improvement” over QLT’s treatment. According to a QLT statement, data from phase III trials for Macugen, a drug being developed by Pfizer and Eyetech Pharmaceuticals “do not appear to offer any treatment benefit over (Visudyne) “.

We feel Visudyne represents true innovation, and based upon our assessment of disease prevalence, treatment efficacy, and demand/diffusion characteristics have designated it a High Impact health technology. We are advising clients to initiate preliminary assessment activities.

Technology Details
Target Disease / Indication: Age Related Macular Degeneration
Technology Classification: Drug-Photodynamic Therapy
Body System: Nervous System
Program Area: Surgery/Ophthalmology
Regulatory Status: Approved
BioHorizon Impact Score: 73/100 – High