QLT Reports Positive Prelim. Results In Phase 1b Retreatment Trial Of QLT091001

(RTTNews) - QLT Inc. (QLTI, QLT.TO) announced positive preliminary results from its international, multi-center, Phase 1b clinical trial of repeated treatments of oral QLT091001 in subjects with Leber Congenital Amaurosis or LCA or Retinitis Pigmentosa or RP due to inherited genetic mutations in retinal pigment epithelium or RPE65 or lecithin:retinol acyltransferase or LRAT.

The company stated that preliminary results of this Phase 1b study showed clinically meaningful improvements in visual fields or VF and visual acuity or VA. To date, 19 of 27 subjects (70%) had an increase in VF retinal area from baseline of = 20% in at least 1 eye at 2 consecutive visits within 6 months from the start of any QLT091001 treatment course. In addition, 70% of subjects had an increase in VA from baseline of = 5 letters in at least 1 eye at 2 consecutive visits within 6 months from the start of any treatment course.

Dosing in the study is now completed and subject follow-up is ongoing. The final clinical data, including duration of response and other evaluations, are anticipated for release in the third quarter of 2014.

The company said that all adverse events reported in this trial were consistent with the retinoid class of medications and were transient and/or reversible. Only one serious adverse drug reaction (intracranial hypertension (ICH), a known class effect of retinoids), was reported in the study and it was resolved.

LCA is an inherited degenerative retinal disease characterized by abnormalities such as roving eye movements and sensitivity to light, and manifesting in severe vision loss from birth. Both rod and cone photoreceptors are affected in LCA. Eye examinations of infants with LCA reveal normal appearing retinas. However, a low level of retinal activity, measured by electroretinography, indicates very little visual function.