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

Iolyx Therapeutics报告了ILYX-002在自身免疫相关干眼症的2期临床试验中取得可喜结果

May 28, 2025

2025年5月28日

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.

Iolyx Therapeutics 宣布了其评估 ILYX-002 治疗与系统性自身免疫或炎症疾病相关的中重度干眼病 (DED) 的 2 期临床试验的鼓舞人心的初步结果。

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..

这项随机、双盲、载体对照试验在澳大利亚的多个地点招募了105名参与者。在为期14天的载体导入期后，患者被随机分配接受ILYX-002或载体对照，每天两次，持续八周，随后是两周的安全性随访期。

Rapid Onset and Durable Efficacy

快速起效和持久疗效

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..

研究的主要终点是结膜总染色，角膜总染色为次要终点。据Iolyx Therapeutics称，ILYX-002在“眼表健康方面显示出显著的临床改善”，早在第15天就达到了两个终点的统计学显著结果。

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

首席研究员马克·辛德斯，眼科视光理学学士，澳大利亚眼科试验创始人，强调了快速反应和良好的安全特性：

“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.

“在这项二期研究中，我观察到眼表出现了具有临床意义的、统计学上显著的改善——令人惊讶的是效果出现得如此之快。在短短两周内就产生了如此显著的治疗差异，这通常只有使用局部类固醇时才会看到，然而我们在耐受性方面没有记录到任何停药情况，也没有发现眼压升高的问题。”

Better still, the benefit was sustained through week 8.”.

“更棒的是，这种益处持续到了第8周。”

Key Efficacy Outcomes

关键疗效结果

•

•

Corneal Staining (tCFS):

角膜染色 (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.

ILYX-002 在第15天显示与安慰剂相比最小二乘均值（LS-mean）优势为-1.41点（p = 0.0015），到第57天增加至-1.78点（p = 0.0021），反映出与基线相比改善了36-44%，而安慰剂组仅为15-17%。

•

•

Conjunctival Staining (tLGCS):

结膜染色（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).

在第15天显示出统计学显著性，最小二乘均值差异为-1.10点（p = 0.0425），并在第57天保持了-0.97点的差异（p = 0.0807）。

Safety Profile and Next Steps

安全性概况与后续步骤

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..

治疗中出现的不良事件大多为轻度至中度。未报告与治疗相关的严重不良事件或因产品使用导致的停药。积极的安全性特征，加上快速且持久的疗效，使ILYX-002有望成为管理自身免疫相关DED的潜在突破。

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.

Iolyx Therapeutics目前正计划进行一项基于ILYX-002-201研究的III期临床试验，预计将于2025年底开始招募。