April 23, 2010 (FinancialWire) — QLT Inc. (NASDAQ: QLTI) (TSX: QLT) announced interim results from the first three subjects enrolled in a Phase 1b clinical proof-of-concept study of QLT091001 in the treatment of Leber congenital amaurosis, an inherited progressive retinal degenerative disease that leads to retinal dysfunction and significant visual impairment beginning at birth.

QLT091001 is an orally administered synthetic retinoid replacement for 11-cis-retinal, which is a key biochemical component of visual function.

The Phase 1b trial is a short-term, open-label, single-center study to evaluate the safety profile and effects on retinal function in eight pediatric subjects (aged 5 to 14 years) diagnosed with LCA due to inherited deficiency of retinal pigment epithelium protein 65 (RPE65) or lecithin: retinol acyltransferase . Based on the positive results from the first two patients, a protocol exception was granted to also treat an adult patient.

Subjects receive daily oral doses of QLT091001 for seven days at the Montreal Children's Hospital at the McGill University Health Centre, Montreal, Canada, under the supervision of the trial's principal investigator, Robert K. Koenekoop, M.D., Ph.D. Patients were monitored to ensure overall safety. Efficacy assessments included several visual function parameters including best-corrected visual acuity and visual field testing.

Three subjects aged 10, 12, and 38 years, all of whom have a genetic mutation in LRAT, have been enrolled and treated to date. After seven days of treatment with QLT091001, all of the subjects experienced clinically relevant improvements in one or more visual function parameters, including best-corrected visual acuity, Goldmann visual field, and/or retinal sensitivity as measured by full-field sensitivity threshold testing.

The results from the first three subjects will be introduced and discussed by Dr. Koenekoop in a previously scheduled mini-symposium entitled, "An Overview of Retinal Dystrophies: from Gene Discoveries to New Therapies" at the Association for Research in Vision and Ophthalmology annual meeting in Fort Lauderdale, Florida on May 3, 2010 at 3: 45 p.m.

According to QLT, the safety and efficacy of QLT091001 remains to be fully evaluated through additional preclinical and clinical testing. QLT091001 cannot be made available to patients with LCA outside of regulated clinical trials, such as the current study.

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