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 oraclinical.
Source
EyeGate Pharma