EyeGate Pharma Initiates Phase III Study of EGP-437 in Patients With Anterior Uveitis
WALTHAM, MA--(Marketwire - January 05, 2012) - EyeGate Pharma today announced that it has enrolled the first patient in a milestone Phase III pivotal study of its lead product EGP-437 (a late-stage asset with multiple indications for inflammatory ocular indications), for the treatment of anterior uveitis. The company, a private specialty pharmaceutical company developing therapeutics designed to address two major issues in ophthalmic medicine, patient compliance and patient throughput, enrolled the patient at Tauber Eye Center in Kansas City, MO.
The randomized double-masked positive-controlled non-inferiority study will enroll up to 200 subjects at more than 20 US sites in order to assess the effectiveness of EGP-437 in comparison to topically applied prednisolone acetate eye drops. EGP-437 will be administered using the EyeGate® II Drug Delivery System, a non-invasive iontophoretic drug delivery technology.
Study investigator, Joseph Tauber, M.D., commented: "Our team is excited to have enrolled the first patient in this key study. This is a truly innovative approach that seeks to address the main issue of compliance by providing the doctor with direct control of the dosing. The Phase II data suggest that EGP-437, when delivered using the EyeGate® II Ocular Drug Delivery System, could lead to a more predictable clinical response and has the potential to improve the way anterior uveitis is treated."
"Based on the positive clinical results from the Phase II study, we are excited to initiate this Phase III study, which we believe will demonstrate significant treatment benefits over traditional treatments with prednisolone acetate. We remain committed to eliminating the major issue of compliance that corneal specialists and their patients struggle with when treating serious inflammatory episodes," said Stephen From, President and CEO of EyeGate Pharma.
Phase II Study Results
The Company's Phase II study results appear in the January 2012 issue of Ophthalmology, a leading ophthalmic peer-reviewed journal. The data revealed that approximately two-thirds of the patients reached an anterior chamber cell score of zero within 28 days, after only receiving one iontophoresis treatment. In addition, no changes in intraocular pressure or signs of cataract formation were detected.
Anterior Uveitis
Responsible for up to 10% of all blindness in the U.S., uveitis is an eye disorder associated with intraocular inflammation of the anterior portion of the uvea, particularly the iris and/or ciliary body. Topically administered corticosteroids are the mainstay treatment. While these drugs are generally helpful in treating the disease, their effectiveness is limited due to insufficient drug absorption and rapid clearance by the eye. To achieve successful therapeutic outcomes, patients must follow a rigorous dosing schedule for up to eight weeks. Patients can be required to self-administer over 360 treatments during this period. Given this substantial burden, patient non-compliance is prevalent and is the main cause of treatment failure, which can lead to permanent loss of vision.
About EGP-437 (dexamethasone phosphate formulated for iontophoresis)
EyeGate expects to commercially launch EGP-437 as early as the end of 2013 for anterior uveitis. The first pivotal Phase III anterior uveitis study has been initiated with top line data expected by the end of 2012. EGP-437 has been granted orphan drug designation by both the FDA and European Medicines Evaluation Agency for corneal graft rejection.
About EyeGate Pharma
Eyegate Pharmaceuticals, Inc. is focused on developing therapeutics designed to address two major issues in ophthalmic medicine, patient compliance and patient throughput. EyeGate has a small, elegant, and easy-to-use device that delivers drugs non-invasively and quickly into the ocular tissues, which can dramatically increase the onset of action. The procedure only takes a few minutes and can be administered by all eye care practitioners. The EyeGate® II Delivery System is compatible with a wide range of therapeutics and has the potential to address many anterior and posterior segment diseases. Over 1,200 treatments have been performed with the EyeGate® II Delivery System and it is the first ocular iontophoresis system to have completed Phase II studies (Dry Eye and Uveitis), and a Phase III study (Dry Eye). For more information, please visit www.eyegatepharma.com.