Active Biotech AB (publ) announced the completion of the phase I clinical study testing the safety and tolerability of the newly developed laquinimod eye drop formulation in healthy subjects. According to the results, the eye drop was safe and well tolerated both at single ascending doses and after repeated doses for up to 21 days. No serious adverse events were reported.

Laquinimod is being developed as a new treatment for inflammatory eye disorders, and preclinical data suggest that laquinimod may have a therapeutic effect when given as a capsule or as a topical treatment onto the eye. The company has developed an eye drop formulation of laquinimod with the aim to use it for treatment initially in patients with non-infectious uveitis. The study was a randomized, double-masked, placebo-controlled phase I study to determine the safety and tolerability and establish a safe and tolerable dose for continued development of laquinimod eye drops after single and repeated dosing in healthy subjects.

Secondary aims included the assessment of ocular toxicity and pharmacokinetics of laquinimod. The complete data set from the study is currently being analyzed, and the full study results will be reported in first half of 2023.