MiDROPS proven safe and effective in clinical application, according to study data

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EyeCRO has announced data from its first clinical application of the company’s MiDROPS, or microemulsion drug ocular penetration system, platform technology as an eye drop vehicle for patients with moderate to severe dry eye disease (DED). The data was presented by Telios Pharma at the Association for Research in Vision and Ophthalmology meeting in Seattle, Washington, according to a news release. The presentation was titled “TL-925, a First-in-Class, Topical, Bruton’s Tyrosine Kinase Inhibitor in Subjects with Moderate to Severe Dry Eye Disease.”¹

“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. 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 Rafal Farjo, PhD, EyeCRO CEO, in the release.

Data found that MiDROPS demonstrated significant capability to safely formulate and deliver lipophilic molecules via topical eye drops in the proof-of-concept Phase 2 study. This was found by evaluating the effect of 0.1% TL-925 versus the MiDROPS vehicle, which was dosed twice daily in 107 patients with moderate to severe DED over 28 days. Both were safe and well-tolerated in the trial, according to the release.

“The inherent nature of MiDROPS allowed us to easily formulate TL-925 and accelerate advancement into clinical trials,” said Jesse McGreivy, CEO of Telios Pharma, in the release. “The clinical data presented today both establishes the safety of this novel vehicle platform and showcases the potentially paradigm-changing role of [Bruton’s tyrosine kinase, or] BTK inhibition to alleviate the signs and symptoms of patients with moderate to severe DED.”

In the study, the mean drop comfort score was 2.6 on a scale of 0-10 in both the treatment and vehicle study eye with the most common treatment-emergent adverse event of low-grade instillation site irritation.¹ “These results demonstrate the impressive safety and tolerability profile of MiDROPS,” the release stated. “Importantly, this is the first clinical study to establish the critical role of BTK in the pathophysiology of DED.”

The release also stated that TL-925 demonstrated clinically meaningful and statistically significant efficacy in multiple signs of DED such as central and total corneal fluorescein staining, as well as symptoms, including pain and dryness and burning as documented on the visual analog scale.¹

Reference:

1. MiDROPS achieves pivotal milestone: Proven safe and effective in Phase 2 clinical trial. News release. Business Wire. May 7, 2024. Accessed May 15, 2024. https://www.businesswire.com/news/home/20240507085882/en/MiDROPS%C2%AE-Achieves-Pivotal-Milestone-Proven-Safe-and-Effective-in-Phase-II-Clinical-Trial