Visudyne clinical results show benefit in AMD patients with occult

Regulatory strategy updated based on these results

ATLANTA and VANCOUVER, BC — Novartis Ophthalmics, the eye health unit of Novartis AG (NYSE:NVS), and QLT Inc. (Nasdaq:QLTI) announced that the American Journal of Ophthalmology, a leading peer-reviewed medical journal, has published favorable two-year results from a Phase III clinical trial, showing Visudyne (verteporfin for injection) therapy has a significant treatment benefit in age-related macular degeneration (AMD) patients presenting with occult without classic choroidal neovascularization (CNV). This is the first time a benefit has been shown in these patients in a large-scale randomized clinical trial.

AMD is the leading cause of blindness in people over the age of 50. The wet form of the disease results from abnormal blood vessels (choroidal neovascularization or CNV) under the central part of the retina. "Occult" and "classic" are terms used to describe the different patterns of CNV leakage as seen on fluorescein angiography.

"Based on these results, ocular photodynamic therapy with Visudyne should be considered as a treatment for AMD patients with lesions composed of occult without classic CNV with presumed recent disease progression," said Neil Bressler, MD. Dr. Bressler is chair of the Visudyne study advisory group and a retinal specialist and professor of ophthalmology at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine in Baltimore.

"The results clearly show that for these patients, Visudyne therapy reduces the risk of moderate and severe vision loss, particularly in cases presenting with either smaller lesions or lower levels of visual acuity," he said.

Julia Levy, MD, president and CEO of QLT, said, "These findings are significant as this patient group currently has no treatment options. To this end, we will aggressively pursue approvals based on these positive results by completing filings in Europe and Canada within the next few months. In the U.S., following discussions with the Food and Drug Administration (FDA), it was determined that in accordance with standard practice, a second trial is necessary for replication. We intend to initiate this study in the third quarter once a protocol has been agreed upon with the FDA."

"This publication, on the heels of the release of favorable three-year data in predominantly classic AMD patients, will broaden the use of Visudyne," said Luzi von Bidder, head of Novartis Ophthalmics. "Visudyne has already gained wide acceptance around the world as an effective treatment for AMD and through the continued publication of strong clinical results such as these, its importance will continue to grow."

The following two-year results are based on 258 AMD patients (76% of the entire study population) with occult CNV without a classic component.

55% of the Visudyne-treated group compared with 68% of the placebo-treated group lost at least 15 letters or 3 lines of vision on a standard eye chart (p equals 0.032) while 29% of the Visudyne-treated group and 47% of the placebo-treated group lost at least 30 letters or 6 lines of vision (p equals 0.004).
All secondary outcomes, including visual acuity letter score less than 34 (20/200 or worse), mean change in visual acuity letter score, development of classic CNV, progression of classic CNV, and size of lesion, favored Visudyne-treated patients.

Further prospectively defined analysis showed that the treatment benefit was greater for patients with either smaller lesions or lower levels of visual acuity at baseline.

Of the 123 Visudyne-treated patients and 64 placebo-treated patients with either visual acuity score less than 65 letters or lesion size less than or equal to 4 disc areas at baseline, 49% (Visudyne) and 75% (placebo) lost at least 15 letters (p less than 0.001). Further, 21% of the Visudyne-treated patients and 48% of the placebo-treated patients lost at least 30 letters (p less than 0.001) at the month 24 examination.

The trial also reconfirmed Visudyne's favorable safety profile as no new safety concerns were identified during the second year of treatment.

As reported earlier, during the first year of treatment 4% of patients experienced an often transient, severe vision decrease within 7 days of the initial treatment.
The most frequently reported adverse events attributed to the treatment were injection site events and visual disturbances. Photosensitivity reactions occurred in less than 1% of patients.

Patients treated with Visudyne received an average of five treatments during the 24-month period.

For more information, visit http://www.visudyne.com.