Eyegate Pharma Initiates Phase I Study of Egp-437 in Patients With Non-Necrotizing Anterior Scleritis
WALTHAM, MA- February 29, 2012 - EyeGate Pharma, a private specialty pharmaceutical company developing ocular therapeutics and a proprietary non-invasive drug delivery platform, announced that it has begun enrolling patients with anterior scleritis into a Phase I study evaluating the safety and effectiveness of its lead product, EGP-437 (a late-stage asset with multiple indications for inflammatory ocular indications).
The randomized, double-masked, placebo-controlled study will evaluate the safety and tolerability of three (3) ocular iontophoresis dose levels of EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) in subjects with non-infectious, non-necrotizing anterior scleritis. The study design allows for a preliminary assessment of the efficacy for single and repeat treatment at three (3) different dose levels. EGP-437 will be administered using the EyeGate® II Ocular Drug Delivery System: a non-invasive, iontophoretic drug-delivery technology. Iontophoresis is an active method of drug delivery in which an electrical field, generated by a low level electrical current, promotes the movement of charged substances (drug products) across biological membranes, allowing for delivery through different tissues to targeted areas.
Partial funding for this study is provided by an FDA orphan drug indication grant, awarded to lead investigator Dr. John Kempen of the University of Pennsylvania School of Medicine. The grant funds enrollment at two clinical sites: The University of Pennsylvania School of Medicine and The Wilmer Ophthalmological Institute in Baltimore, Maryland. Supplemental funding by EyeGate Pharma will expand the study to four additional sites. Up to 24 patients will be recruited into the study.
"We look forward to testing and evaluating EyeGate's iontophoretic drug delivery technology for the treatment of anterior scleritis," said Dr. Kempen. "We hope that this approach will provide more controlled local delivery of a corticosteroid through the episcleral/conjunctival plexus and will be as effective as subconjunctival injections of depot-corticosteroids, with fewer risks. Such a treatment would be of great benefit to patients suffering with anterior scleritis."
"Due to insufficient drug absorption and rapid clearance by the eye, topical corticosteroids require a rigorous dosing schedule to achieve a successful therapeutic outcome. Ophthalmologists and their patients struggle with this burden and noncompliance significantly contributes to treatment failure. Peri- or intra-ocular injections are an alternative treatment to eye drops; however, the injections introduce substantial risks to patients. We remain committed to eliminating the compliance issue and providing a safer alternative to treating serious inflammatory episodes," said Stephen From, President and CEO of EyeGate Pharma.
A severe medical condition causing chronic, painful and potentially blinding inflammation of the sclera (the outer white wall of the eye), scleritis is often associated with autoimmune diseases, such as rheumatoid arthritis, and most often affects persons between the ages of 30 and 60. Approximately 80% of cases are non-necrotizing, involving the anterior portion of the sclera.
Topical corticosteroids for scleritis have very limited effect. Other therapies typically involve a "stepladder" approach, beginning with oral, non-steroidal anti-inflammatory drugs before progressing to oral corticosteroids and immunosuppressive agents (for severe cases). Because the sclera is avascular, drug delivery via systemic circulation proves difficult. Subconjunctival injections of depot-corticosteroids have been exceptionally effective, but use is severely limited by concerns about potentially severe side effects.
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 was initiated in January 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 features 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.
President & CEO