Telios Pharma Announces Phase 2 Results for TL-925, a Novel Treatment for Dry Eye Disease

Telios Pharma announced topline results from its phase 2 study assessing TL-925, a first-in-class topical Bruton’s tyrosine kinase (BTK) inhibitor for individuals with moderate to severe dry eye disease (DED). This proof-of-concept, multicenter, randomized, double-masked study evaluated the safety, tolerability, and efficacy of TL-925 versus vehicle control, when dosed twice daily for 28 days.

A total of 107 subjects with moderate to severe DED were enrolled. TL-925 was safe and well tolerated and the intention-to-treat analysis demonstrated clinically meaningful and statistically significant efficacy relative to vehicle control across multiple signs and symptoms. The rapid onset of efficacy across multiple ocular regions, coupled with favorable and consistent results in different environments, confirm TL-925’s profile as a safe, well-tolerated, and effective treatment for patients with DED, according to Telios.

Complete results will be presented at the upcoming Association for Research in Vision and Ophthalmology (ARVO) annual meeting 2024, to be held from May 5-9, 2024, in Seattle, Washington.

Poster: 2965 - A0124
Title: TL-925, a First-in-Class, Topical, Bruton’s Tyrosine Kinase Inhibitor in Subjects with Moderate to Severe Dry Eye Disease
Session: 316
Date & Time: May 7, 2024, 08:30 - 10:15

“We are thrilled by these findings and honored to have been selected to share our groundbreaking research with the ophthalmology community at ARVO,” Jesse McGreivy, CEO of Telios Pharma, said in a company news release. “Our team is excited about advancing TL-925 through the next stages of clinical development with the aim of further demonstrating its ability to address the underlying cause of dry eye disease, an underdiagnosed and often poorly managed condition that affects many millions of people worldwide.”

A phase 2b study of TL-925 in DED has been initiated based on these results and is currently enrolling patients. Consistent with TL-925’s efficacy in DED, a separate phase 2 study evaluating the safety and efficacy of TL-925 in individuals with allergic conjunctivitis (AC) has recently shown clinically meaningful and statistically significant improvements in both itching and redness. These data will be presented at a medical congress later this year.