A first-in-human phase 2 clinical trial of ILYX-002, a topical immunomodulator for moderate-to-severe dry eye disease (DED) associated with systemic autoimmune or inflammatory conditions, demonstrated clinical improvement in patients’ ocular surface health. 

Iolyx Therapeutics’ ILYX-002-201 study was conducted across multiple sites in Australia and included a 14-day vehicle run-in period, with a total of 105 participants subsequently randomised to receive either ILYX-002 or control, administered twice daily for eight weeks.  

With a clinically meaningful trend in the primary endpoint of total conjunctival staining and a statistically significant finding on the secondary endpoint of total corneal staining, the study showed a meaningful clinical improvement in ocular surface health, said the company. Notably, the study met significance for both staining endpoints at day 15, highlighting a rapid onset of action, and durable effects through day 57 when compared to a vehicle control. 

Mark Hinds, founder of Ophthalmic Trials Australia and principal investigator for the trial, said ILYX-002 offers a durable response for patients who have had very few safe options. “A treatment difference of this magnitude in just two weeks is something we normally see only with topical steroids, yet we recorded zero discontinuations for tolerability and no IOP concerns.” 

Planning is ongoing for a phase 3 study and is slated to begin in late 2025, said Iolyx.