MiDROPS® Achieves Pivotal Milestone: Proven Safe and Effective in Phase II Clinical Trial
May 07 2024 - 1:30PM
Business Wire
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.
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).
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.
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.
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