EyeCRO Presents Phase 2 Results for MiDROPS Platform

EyeCRO has announced that data from the first clinical application of its MiDROPS (Microemulsion Drug Ocular Penetration System) platform technology was presented by Telios Pharma at the Association for Research in Vision and Ophthalmology (ARVO) meeting in Seattle, WA. The presentation entitled, “TL-925, a First-in-Class, Topical, Bruton’s Tyrosine Kinase Inhibitor in Subjects with Moderate to Severe Dry Eye Disease” (Poster 2965 – A0124), demonstrated MiDROPS' capability to safely formulate and deliver lipophilic molecules via topical eye drops, showcasing the technology’s significant potential in revolutionizing eye care.

This proof-of-concept phase 2 study evaluated the effect of 0.1% TL-925 vs vehicle, dosed twice daily, in 107 patients with moderate to severe dry eye disease (DED) over 28 days. Both TL-925 and the MiDROPS vehicle were safe and well-tolerated. Mean drop comfort score was 2.6 (scale: 0-10) in both the treatment and vehicle study eye with the most common treatment-emergent adverse event of low-grade (grade 1) instillation site irritation. These results demonstrate the safety and tolerability profile of MiDROPS, according to EyeCRO.

This is the first clinical study to establish the role of Bruton’s tyrosine kinase (BTK) in the pathophysiology of DED. Specifically, TL-925 demonstrated clinically meaningful and statistically significant efficacy (intention-to-treat, N=107) across multiple signs of DED, including central and total corneal fluorescein staining (P=0.01 and P=0.034, respectively) and symptoms of DED, Visual Analog Scale - pain, OD4SQ - dryness and burning (P=0.014, P=0.026, and P=0.034, respectively).

MiDROPS utilizes a unique approach with its single-phase microemulsions which incorporate surfactant levels surpassing those previously explored in ophthalmic treatments.

“We are elated to establish this important clinical proof-of concept for MiDROPS as an eye drop vehicle. The data fundamentally demonstrate that these ordered formulations can be safely applied and confer therapeutic activity," Rafal Farjo, PhD, CEO of EyeCRO, said in a company news release. "We are excited for the potential of this platform technology to revolutionize the way ophthalmic drugs are formulated and delivered via eyedrops to tissues of both the anterior and posterior segment."