Marketwire
Based on the top-level analysis of a Phase II
study, EyeGate Pharma announces that EGP-437, a corticosteroid solution
administered by a
non-invasive ocular drug delivery system, improved signs and symptoms in
patients with dry eye syndrome (DES).
For the dry eye clinical trial, EyeGate worked with Ora, Inc., a leading
global clinical research and development organization located in Andover,
MA. Over the past 30 years, Ora has been a pioneering force in the
development of advanced research models across the field of ophthalmology.
This Phase II single-center, randomized (105 patients), double-masked,
placebo-controlled patient study evaluated the safety and efficacy of a
corticosteroid solution (EGP-437) administered by the EyeGate® II
Delivery System (at two dose levels) twice over a three-week period. Ora's
Controlled Adverse Environment (CAE) clinical research system, which
simulates the acute environmental challenges regularly faced by DES
patients, was used for this study.
In the top-level analysis, investigators observed that EGP-437
significantly (p < 0.05) improved signs and symptoms of DES during the
three-week environmental component, which included three CAE exposures and
two doses. EGP-437 also improved signs and symptoms when studied as a
treatment and preventative in conjunction with the CAE.
"This exploratory Phase II study demonstrated significant improvements in
signs and symptoms of dry eye during and after CAE exposure following
EGP-437 dosing. These effects were observed within hours of dosing,
suggesting a rapid onset of action. In addition, EGP-437 significantly
improved the post-CAE recovery for patients in the active treatment groups.
The impact on signs and symptoms was also observed during the study's
three-week environmental component, further supporting the potential
benefits of
EGP-437 for these patients," commented George Ousler, Director of Dry Eye
Department at Ora.
According to Stephen From, President and CEO of EyeGate Pharma, "Ora's CAE
clinical research system, which provides a unique ability to screen and
qualify patients, played an integral role in minimizing the study's patient
numbers while still delivering highly relevant biostatistics. We are
excited about the prospect that EGP-437 may prove to be a useful therapy
for the moderate to severe dry eye patients that are currently underserved
by available treatments. This non-invasive drug delivery technology has the
potential to help patients with a broad range of eye diseases, and we are
encouraged by these results."
An abstract describing the study and results was submitted to an upcoming
scientific conference, for which more details will follow.
About Dry Eye Syndrome
Dry Eye Syndrome (DES) is the most prevalent form of ocular discomfort and
irritation, accounting for one in four patient visits to a general
ophthalmologist. It is estimated that as many as 20 to 40 million Americans
suffer from DES, including a significant number of patients who suffer from
DES after Lasik surgery. Symptoms such as pain, light sensitivity, blurred
vision, and irritation decrease the quality of life for patients and can
ultimately lead to loss of function and blindness. The incidence of DES is
increasing due to environmental factors, the aging population and the
increasing prevalence of co-morbid diseases such as diabetes. There is no
cure for DES, and the few treatment options currently available primarily
provide temporary symptomatic relief.
About Ora, Inc.
Ora is the world's leading independent ophthalmic drug and device
development firm. Ora provides technology-based concept-to-market services
and solutions that accelerate development timelines and improve the
scientific quality of clinical research. Over the past 30 years, Ora has
played a central role in the development and FDA approval of more than 30
ophthalmic products. For more information, please visit
www.oraclinical.com.
About EyeGate Pharma
Eyegate Pharmaceuticals, Inc., was founded in 1998 with technology licensed
from Bascom Palmer Eye Institute at the University of Miami. EyeGate's
transscleral (white membrane of the eye) iontophoresis delivery platform,
the EyeGate® II Delivery System, was developed to safely deliver a wide
range of therapeutics to both the anterior and posterior chambers of the
eye. For more information, please visit www.eyegatepharma.com.
