• Daily treatment with laquinimod eye drops resulted in dose related and therapeutically relevant concentrations of laquinimod in both the anterior and posterior parts of the eye.

• Laquinimod eye drop treatment was safe and tolerable during 14 days’ administration

Lund, May 5, 2025 – Active Biotech (NASDAQ STOCKHOLM: ACTI) today announced positive top-line results from the clinical phase I LION study. Patients scheduled to undergo pars plana vitrectomy for various elective indications were administered laquinimod daily as eye drops during a 14-day preoperative period.

The top-line results from the LION study (Safety, Tolerability, and Distribution of Topical Laquinimod Eye Drops, an Innovative ImmunomodulatOr Targeting Aryl HydrocarboN Receptor) 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.

“It is tremendously satisfying to learn that topical laquinimod, even at a low dose, can penetrate into the anterior chamber and, more importantly, the vitreous of human eyes,” said Quan Đông Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology, Medicine and Pediatrics at the Byers Eye Institute and the Stanford University School of Medicine (Palo Alto, USA) and Principal Investigator of the LION Study.

Importantly, these results demonstrate that laquinimod, when administered topically by patients as an eye drop, can yield intra-ocular concentrations in the posterior parts of the eye, which are known to affect ongoing inflammatory processes. These data support a continued development of laquinimod eye drops for patients with non-infectious inflammatory eye-diseases.

“The potential applications of a topical formulation and delivery that reaches the vitreous and likely posterior segment are quite significant and can lead to very important and novel therapeutic implications. Our talented team at Byers and Stanford is very excited with the outcomes of the study,” said Dr. Nguyen.

The LION study will be given as an oral presentation at the upcoming 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.

Active Biotech’s focus for the laquinimod program is now directed towards identifying the best development partner for the continued clinical development of laquinimod in eye disorders.