TL-925 Phase 2 Success: Innovative Dry Eye Disease Therapy

Telios Pharmaceuticals, a biopharmaceutical firm at the forefront of developing treatments for inflammatory conditions, has unveiled promising results from a Phase 2 clinical trial of TL-925, an innovative eye drop designed to combat dry eye disease (DED). The study, which was a randomized, double-masked, multicenter trial, involved 107 participants suffering from moderate to severe DED. The trial's primary focus was on the safety, tolerability, and efficacy of TL-925 when administered twice daily over a 28-day period.

TL-925 is distinguished as a first-in-class topical Bruton’s tyrosine kinase (BTK) inhibitor, specifically targeting ocular inflammation and allergies mediated by mast cells. The trial's results indicated that TL-925 not only proved safe and well-tolerated but also demonstrated significant improvements in the signs and symptoms of DED when compared to a placebo. The rapid efficacy across various ocular regions and consistent performance across different environments underscore the potential of TL-925 as an effective treatment option for DED patients.

The comprehensive findings of the study are slated to be presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Seattle, Washington, scheduled from May 5 to May 9, 2024. The poster presentation, titled "TL-925, a First-in-Class, Topical, Bruton’s Tyrosine Kinase Inhibitor in Subjects with Moderate to Severe Dry Eye Disease," is expected to attract significant attention from the ophthalmology community.

Jesse McGreivy, CEO of Telios Pharmaceuticals, expressed enthusiasm for the study's outcomes and the opportunity to present the research at ARVO. He highlighted the company's commitment to advancing TL-925 through further clinical development to address the root cause of DED, a condition that impacts millions globally and is often underdiagnosed and inadequately managed.

George Ousler, the lead investigator and Senior Vice President at Ora Inc., praised the study's positive results and the potential impact of TL-925 on the underlying pathology of DED. He noted the impressive nature of the results, which he considers to be among the best in his experience with dry eye clinical development programs.

Building on the positive outcomes, a Phase 2b study of TL-925 for DED is underway, actively enrolling patients. Additionally, a separate Phase 2 study has shown significant improvements in itching and redness for individuals with allergic conjunctivitis (AC), indicating TL-925's potential in treating related ocular inflammatory disorders.

Dr. Gail Torkildsen, a principal investigator in both studies and an ophthalmologist, emphasized the coexistence of DED and AC and the unique challenges they present. She noted that the positive results in both conditions suggest TL-925's ability to halt inflammation cycles and target the inflammatory mechanisms behind these diseases, potentially marking a significant advancement in treatment.

TL-925's novel approach to treating DED involves targeting BTK, which plays a critical role in mast cell activation and immune response. By preventing mast cell activation and degranulation, TL-925 blocks the cytokine-driven inflammatory response and restores the balance of the lacrimal unit, offering a potential disease-modifying treatment for DED.