QLT Inc. has announced that the first patient in the company’s phase IIa proof-of-concept trial of QLT091001 in adult subjects with impaired dark adaption (IDA) has been dosed.
Vancouver, British Columbia-QLT Inc. has announced that the first patient in the company’s phase IIa proof-of-concept trial of QLT091001 in adult subjects with impaired dark adaptation (IDA) has been dosed.
The trial is a randomized, multicenter, parallel-group, placebo-controlled study.
Patients (age 60 or older) with IDA or impaired low luminance low contrast best-corrected visual acuity (LLLC BCVA) in at least one eye and who have no known ophthalmic pathologies to explain their condition-other than early age-related macular degeneration-will be enrolled at sites in the United States.
Patients will be randomly assigned to receive the placebo or one of two different doses (10 or 40 mg/m2) of the drug once per week for 3 consecutive weeks with one additional dose the day after the third dose.
The trial is designed to evaluate the safety profile and effects of the drug on IDA time, glare recovery time, and LLLC BCVA.
“We are pleased that dosing of the first patient has occurred on schedule, marking another significant milestone for QLT in the advancement of our synthetic oral retinoid program in multiple indications,” said Jason M. Aryeh, board chairman of QLT. “This is an important step outside of rare orphan diseases with (the drug), one which is designed to illustrate its potential in a significantly larder patient population.”
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