Iolyx Therapeutics Reports Promising Phase 2 Results for ILYX-002 in Autoimmune-Associated Dry Eye Disease

Iolyx Therapeutics has announced encouraging top-line results from its Phase 2 clinical trial evaluating ILYX-002 for the treatment of moderate-to-severe dry eye disease (DED) associated with systemic autoimmune or inflammatory conditions.

The randomized, double-masked, vehicle-controlled trial enrolled 105 participants across multiple sites in Australia. Following a 14-day vehicle run-in period, patients were randomized to receive either ILYX-002 or a vehicle control, administered twice daily for eight weeks, followed by a two-week safety follow-up period.

Rapid Onset and Durable Efficacy

The study’s primary endpoint was total conjunctival staining, with total corneal staining as the secondary endpoint. According to Iolyx Therapeutics, ILYX-002 demonstrated a “meaningful clinical improvement in ocular surface health,” achieving statistically significant results for both endpoints as early as day 15.

Principal investigator Mark Hinds, BSc Optom, founder of Ophthalmic Trials Australia, emphasized the rapid response and favorable safety profile:

“In this Phase 2 study I observed clinically meaningful, statistically significant improvements on the ocular surface—and what’s remarkable is how fast the effect appeared. A treatment difference of this magnitude in just 2 weeks is something we normally see only with topical steroids, yet we recorded zero discontinuations for tolerability and no IOP concerns. Better still, the benefit was sustained through week 8.”

Key Efficacy Outcomes

       • Corneal Staining (tCFS): ILYX-002 showed a least-squares mean (LS-mean) advantage of -1.41 points vs. vehicle at day 15 (p = 0.0015), increasing to -1.78 points at day 57 (p = 0.0021), reflecting a 36–44% improvement from baseline compared to 15–17% with vehicle.

       • Conjunctival Staining (tLGCS): Demonstrated statistical significance at day 15 with a -1.10-point LS-mean difference (p = 0.0425) and maintained a -0.97-point separation at day 57 (p = 0.0807).

Safety Profile and Next Steps

Treatment-emergent adverse events were mostly mild to moderate. No treatment-related serious adverse events or discontinuations due to product instillation were reported. The positive safety profile, combined with rapid and durable efficacy, positions ILYX-002 as a potential breakthrough in managing autoimmune-associated DED.

Iolyx Therapeutics is currently planning a Phase 3 clinical trial modeled on the ILYX-002-201 study, with enrollment expected to begin in late 2025.