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Phase 2 Trial Results of Topically Administered ILYX-002, a Novel Immune Modulator for Inflammatory and Autoimmune Dry Eye Disease

Presenter:

Erin Newman

Authors:

Erin Newman, Houman Hemmati, Elizabeth Jeffords

Iolyx Therapeutics, Inc.

Affiliation:

Purpose

This randomized, double-masked, vehicle-controlled, multicenter Phase 2 trial, ILYX-002-201, was designed to evaluate the safety, tolerability, and efficacy of a potent and selective immune modulator, ILYX-002, in patients with moderate-to-severe dry eye disease (DED) associated with systemic inflammatory or autoimmune disorders.

Methods

A sentinel cohort (n=2) was closely monitored by a Safety Review Committee and gated Phase 2 recruitment. Patients with moderate to severe DED and at least one inflammatory disease or autoimmune disorder were randomized to receive ILYX-002 (0.3%) or vehicle self-administered twice daily for 8 weeks following a 14-day vehicle run-in period. Safety was assessed throughout the trial. Intraocular pressure (IOP) was measured and ocular tolerability (OT) was assessed by visual analogue scale (VAS). Total corneal fluorescein staining (tCFS) and central CFS (cCFS) scores were assessed by the Lexitas modified NEI staining scale (0-4 with 0.5 increments) to evaluate change over time.

Results

A total of 104 participants were randomized and received study treatment (ILYX-002: n=53; vehicle: n=51). Adverse events were generally mild to moderate in severity. IOP remained stable, and ILYX-002 was well tolerated, with improvement of OT VAS over time.

The mean tCFS score (±SEM) in the ILYX-002 treatment group decreased from 6.61±0.276 at baseline to 3.61±0.379 at Week 8, with a difference of -2.90±0.420 and a statistically significant difference of -1.78 (P=0.0021) compared to vehicle (Figure 1). The onset of action was rapid, with a difference by Day 15 of -2.41±0.304 in the treatment arm and a statistically significant difference of -1.41 (P=0.0015) compared to vehicle. The cCFS score in the ILYX-002 treatment group decreased from 0.98±0.118 at baseline to 0.36±0.074 at Week 8 with a statistically significant difference of -0.21 (P=0.0437) compared to vehicle (Figure 2).

Conclusions

In this Phase 2 trial, ILYX-002 was safe and well tolerated, with early signs of efficacy sustained through end of treatment. These data highlight the potential of ILYX-002 to provide clinically meaningful improvement in signs of DED and support further investigation.

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