MiDROPS® Achieves Pivotal Milestone: Proven Safe and Effective in Phase II Clinical Trial

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Published May 07, 2024 • 3 minute read

OKLAHOMA CITY — EyeCRO is thrilled to announce that groundbreaking data from the first clinical application of its innovative MiDROPS® platform technology is being presented by Telios Pharma at the 96th meeting of the Association for Research in Vision and Ophthalmology 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® exceptional capability to safely formulate and deliver lipophilic molecules via topical eyedrops, showcasing the technology’s significant potential in revolutionizing eye care.

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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 impressive safety and tolerability profile of MiDROPS®. Importantly, this is the first clinical study to establish the critical 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).

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Setting a new standard in eye care, 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 eyedrop vehicle. The data fundamentally demonstrate that these ordered formulations can be safely applied and confer therapeutic activity. 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,” said Dr. Rafal Farjo, Chief Executive Officer of EyeCRO.

Echoing this sentiment, Dr. Jesse McGreivy, CEO of Telios Pharma, highlighted the strategic benefits of this collaboration, “The inherent nature of MiDROPS® allowed us to easily formulate TL-925 and accelerate advancement into clinical trials. The clinical data presented today both establishes the safety of this novel vehicle platform and showcases the potentially paradigm-changing role of BTK inhibition to alleviate the signs and symptoms of patients with moderate to severe DED.”

About MiDROPS®

MiDROPS® (Microemulsion Drug Ocular Penetration System) is a revolutionary platform technology which employs cutting-edge microemulsions to formulate and deliver lipophilic and insoluble drugs via topical eyedrops. This innovative approach allows for the effective treatment of eye diseases by facilitating drug delivery directly into tissues of both the anterior and posterior segments of the eye, a feat not possible with traditional ophthalmic formulations. This broad library of single-phase microemulsions represents a breakthrough in ophthalmic drug delivery, offering enhanced bioavailability, greater therapeutic efficacy, and improved patient compliance. MiDROPS® is protected by patents globally, ensuring its unique formulations remain exclusive to EyeCRO, which it makes available on a licensing basis to interested parties. For more information, visit MiDROPS.com.

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About EyeCRO

EyeCRO is at the forefront of ophthalmic research, recognized as a leading Contract Research Organization dedicated to advancing the frontiers of vision research and new therapeutic development. Their experienced scientific team provides a wide range of services, including preclinical pharmacology and eyedrop formulation development with MiDROPS®, tailored to support groundbreaking ophthalmic development programs. The company operates laboratories in Oklahoma City, OK and Ann Arbor, Michigan and extends its specialized services to partners worldwide. For more information, visit EyeCRO.com.