| Presentation preference | Oral presentation |
| Title | Phase 2 Trial Results of ILYX-002, a Topically Administered Novel Immune Modulator for Inflammatory and Autoimmune Dry Eye Disease |
| Accept poster if oral is not possible ? | Yes |
| Purpose | This randomized, double-masked, vehicle-controlled, multicenter Phase 2 trial was designed to evaluate the safety and efficacy of a potent and selective immune modulator, ILYX-002, in patients with moderate-to-severe dry eye disease (DED) associated with systemic autoimmune or inflammatory disorders. |
| Methods | The study included patients with at least one inflammatory disease or autoimmune disorder randomized to ILYX-002 (0.3%) or vehicle self-administered twice daily for 8 weeks. Safety was assessed throughout the trial. Total corneal fluorescein staining (tCFS) scores were assessed by the Lexitas modified National Eye Institute (NEI) staining scale (0-4 with 0.5 increments). |
| Results | Participants (n=104) were randomized and received study treatment (ILYX-002: n=53; vehicle: n=51). ILYX-002 was well tolerated. The mean tCFS score (±SD) in the ILYX-002 treatment group decreased from 6.61±1.99 at baseline to 3.61±2.68 at Week 8, with a difference of -2.90±3.03 and a statistically significant mean change of -1.78 (P=0.0021) compared to vehicle. The onset of action was rapid, with a mean change by Day 15 of -2.41±2.15 in the treatment arm and a statistically significant difference of -1.41 (P=0.0015) compared to vehicle. |
| Conclusion | ILYX-002 was well tolerated with early signs of efficacy sustained through the end of treatment. These data highlight the potential of ILYX-002 to provide clinically meaningful improvement in signs of DED and support further investigation. |
| Conflict of interest | Yes |
| Details of conflicting interests | All authors are employees of Iolyx Therapeutics. |
1
| Last name | JEFFORDS |
| Initials of first name(s) | E |
| Department | Iolyx Therapeutics |
| City | Burlingame |
| Country | United States |
2
| Last name | Newman |
| Initials of first name(s) | E |
| Department | Iolyx Therapeutics |
| City | Burlingame |
| Country | United States |
3
| Last name | Hemmati |
| Initials of first name(s) | H |
| Department | Iolyx Therapeutics |
| City | Burlingame |
| Country | United States |
