June 18, 2025
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Key takeaways:
- Dry eye illness related to systemic autoimmune or inflammatory situations considerably improved with ILYX-002 after 15 days.
- ILYX-002 targets a number of pathways concerned in dry eye, together with Th17/Th1.
Part 2 outcomes had been optimistic for ILYX-002, a topical immunomodulator for reasonable to extreme dry eye illness related to systemic autoimmune or inflammatory situations, in response to a press launch from Iolyx Therapeutics.
“What’s superb about ILYX-002 is that it’s a potent broad-spectrum anti-inflammatory that’s focused to a variety of the very particular pathways which might be concerned in dry eye,” Houman Hemmati, MD, PhD, head of medical at Iolyx, advised Healio. “It targets very particular pathways equivalent to [Th17/Th1] and, because of that, can be a tailored, virtually ultimate drug to deal with sufferers who’ve immune-mediated dry eye illness.”
ILYX-002 is the primary pipeline drug that Iolyx has delivered to part 2 whereas specializing in the overlap between immunology and ophthalmology.
“The corporate has actually been targeted on making an attempt to create medicine that benefit from steroids with out the immunosuppressive baggage in addition to the uncomfortable side effects of steroids,” Hemmati stated. “That’s actually the holy grail and main unmet want in ophthalmology.”
In contrast with automobile management, sufferers handled with twice-daily ILYX-002 had a –1.41-point least squares imply benefit in complete corneal fluorescein staining after 15 days of therapy, which elevated to a –1.78-point benefit at day 57 (P = .0021).
ILYX-002 additionally led to a –1.1-point least squares imply distinction in lissamine inexperienced conjunctival staining at day 15 (P = .0425). At day 57, the separation was maintained at –0.97 factors.
“What’s outstanding is how briskly the impact appeared,” Mark Hinds, BScOptom, principal investigator of the ILYX-002-201 trial, stated within the launch. “A therapy distinction of this magnitude in simply 2 weeks is one thing we usually see solely with topical steroids, but we recorded zero discontinuations for tolerability and no IOP considerations. Higher nonetheless, the profit was sustained by week 8, confirming a sturdy response for sufferers who’ve had only a few protected choices.”
There have been additionally “significant 10- to 20-point enhancements” throughout a number of symptom and high quality of life scores in sufferers handled with ILYX-002, in response to the discharge. Most treatment-emergent antagonistic occasions had been delicate to reasonable.
Hemmati stated there’s “little cause to imagine” ILYX-002 wouldn’t be efficient in dry eye illness normally, no matter autoimmunity.
“Despite the fact that we haven’t but included these sufferers in our trials, we all know that the final dry eye inhabitants tends to reply fairly decently to topical anti-inflammatories,” he stated.
Iolyx plans to start its part 3 program by early subsequent 12 months and full it in 2028, Hemmati stated. It’s going to encompass two registration research of round 300 sufferers every, in addition to a 12-month security extension trial involving round 150 sufferers, he stated.
“Our intent is to conduct the part 3 within the business unit dose product, which is preservative free, in order that we’re able to commercialize as quickly as we get approval,” he stated.
Editor’s word: Feedback on this article had been up to date to extra precisely replicate the corporate’s plans and the potential effectiveness of ILYX-002.
For extra info:
Houman Hemmati, MD, PhD, might be reached at hhemmati@iolyx.com or X @houmanhemmati.
Sources/Disclosures
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Disclosures:
Hemmati studies being the top of medical for Iolyx in a consulting capability and receiving compensation within the type of money and inventory choices.
