The study was conducted at the Byers Eye Institute at Stanford University, US, and the principal investigator was Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology, Medicine and Pediatrics at Stanford University School of Medicine.
Laquinimod – Eye Drops, Ocular Biodistribution
Partners: Stanford MedicineGorcUSA
A biodistribution study, LION-studien (Safety, Tolerability, and Distribution of Topical Laquinimod Eye Drops, an Innovative ImmunomodulatOr Targeting Aryl HydrocarboN Receptor), in patients who are to undergo vitreous surgery was initiated in April 2024, the clinical part has been completed and patient recruitment is finished and the enrolment has been completed. The study investigates the concentration of laquinimod in the back and front of the eye after increasing doses of the eye drop formulation. The primary objective was to evaluate whether laquinimod reaches the posterior chamber of the eye to support further development in patients with Non-Anterior-Non-Infectious Uveitis. Patients undergoing planned vitreous surgery received daily doses of laquinimod eye drops in the eye undergoing surgery. Up to 15 patients divided into separate dose groups received laquinimod for 14 days prior to surgery, whereafter samples from anterior chamber fluid (ACF) and vitreous humor (VH) analyzed together with plasma samples for concentration of laquinimod.
The top-line results show that daily dose levels of either 0.6, 1.2 and 1.8 mg resulted in dose related intraocular concentrations of laquinimod, which reached a therapeutically relevant level in both the vitreous humor and anterior chamber. Laquinimod administered as eye drops at the chosen daily dose levels was safe and well tolerated for the period of administration studied, and no dose-limiting toxicities were reported in any of the subjects.
The data were presented as an oral presentation at the International Ocular Inflammation Society (IOIS) Congress, the largest scientific meeting in the field of uveitis and ocular inflammation in the world, in Rio de Janeiro, Brazil, on June 26, 2025 and at the American Academy of Ophthalmology (AAO) annual meeting in October 2025.
The study was conducted at the Byers Eye Institute at the University of Stanford, USA, and the Principal Investigator was Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology, Medicine and Pediatrics, Stanford University School of Medicine. For more information on the study please visit clinicaltrials.gov (NCT06161415).
Completed - Phase I
Stanford MedicineGorcUSA
NCT06161415
Developed for the treatment of severe eye diseases, such as non-infectious posterior uveitis. Ready for clinical Phase II. Activities to establish commercial partnerships are ongoing.
