Iolyx Therapeutics announced top-line data from its phase 2 trial of ILYX-002, a topical immunomodulator for moderate-to-severe dry eye disease (DED) associated with systemic autoimmune or inflammatory conditions. According to a company press release, findings from the 105-patient, multi-site study in Australia include:

• Rapid and Durable Corneal Healing: ILYX-002 produced a -1.41-point LS-mean advantage vs the vehicle control in total corneal fluorescein staining (tCFS) as early as day 15 (p = 0.0015), increasing to -1.78 points at day 57 (p = 0.0021). These results indicate a 36% to 44% improvement from baseline in the active arm vs 15% to 17% with vehicle control. 
  
• Clinically Meaningful Conjunctival Response: On the conjunctival endpoint, measured by lissamine green conjunctival staining (tLGCS), ILYX-002 achieved statistical significance at day 15 with a -1.10-point LS-mean difference (p = 0.0425). At day 57, the drug maintained a -0.97-point separation (p = 0.0807).
• Consistent Symptom and Quality of Life Signals: Exploratory patient-reported outcomes showed meaningful 10- to 20-point improvements in multiple symptoms and quality of life sub-scores.
• Favorable Safety and Tolerability: Treatment-emergent adverse events were mostly mild to moderate, with no treatment-related serious adverse events and no discontinuations related to product instillation. Mean instillation-tolerability scores remained in the mild range (< 30 out of 100), were described as transient, and declined over time with an improvement in corneal staining, while intraocular pressure (IOP) stayed within normal limits. No drug-related serious ocular events were observed, supporting chronic administration.

"In this phase 2 study I observed clinically meaningful, statistically significant improvements on the ocular surface—what’s remarkable is how fast the effect appeared," Mark Hinds, BSc Optom, Founder of Ophthalmic Trials Australia and Principal Investigator for the phase 2 trial, said in the press release. "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, confirming a durable response for patients who have had very few safe options.”

According to the press release, Iolyx plans to commence a phase 3 study in late 2025.