6-month results from EVEREST study evaluating Visudyne(R) therapy in patients with polypoidal choroidal vasculopathy

VANCOUVER, Dec. 9 / QLT Inc. (NASDAQ: QLTI; TSX: QLT) ("QLT" or the "Company") welcomed the 6-month results from the Novartis-sponsored EVEREST study which were presented during a scientific review today by Novartis in Basel, Switzerland. EVEREST is the first multi-center, double-masked, indocyanine green angiography (ICG-A) -guided randomized controlled trial with an angiographic treatment outcome designed to assess the effect of Visudyne(R) (verteporfin photodynamic therapy) alone or in combination with Lucentis(R) (ranibizumab) compared with Lucentis alone in patients with symptomatic macular polypoidal choroidal vasculopathy (PCV). A total of 61 PCV patients of Asian ethnicity from 5 countries (Hong Kong, Taiwan, Korea, Thailand, and Singapore) participated in the study.

The key results from EVEREST include:

- Complete Polyp Regression (primary endpoint): Visudyne combination
with Lucentis and Visudyne monotherapy showed a significantly higher
proportion of patients with complete polyp regression at month 6 than
the Lucentis monotherapy group. Complete polyp regression was
achieved in 77.8% of patients who received the Visudyne - Lucentis
combination, while 71.4% of Visudyne monotherapy patients had
complete regression compared with 28.6% of patients in the Lucentis
monotherapy group (p=0.0018 for combination,
p=0.0037 for Visudyne vs. Lucentis).
- Best Corrected Visual Acuity from baseline to Month 6: On average,
patients in all groups gained vision, with patients in the
combination group achieving the highest gain (+10.9 letters from
baseline). Lucentis monotherapy patients gained +9.2 letters, and
Visudyne monotherapy patients +7.5 letters. Differences between the
groups are not statistically significant.
- All therapies were well tolerated and the safety findings were
consistent with the established safety profiles of Visudyne and
Lucentis.
"EVEREST suggests that in a majority of patients, Visudyne therapy, with or without Lucentis, may lead to complete regression of the polyps that can cause vision loss in patients with PCV, a potentially devastating eye disease," said Bob Butchofsky, President and Chief Executive Officer of QLT. "While published case studies had implied this effect, EVEREST is, to our knowledge, the first randomized, controlled trial designed to corroborate such observations."