WALTHAM, MA--(Marketwire - December 18, 2012) - EyeGate Pharma, a privately held specialty pharmaceutical company developing a non-invasive ocular drug delivery platform and ocular therapeutics, announces today that they have enrolled the last patient in the pivotal Phase III study of EGP-437 in patients with anterior uveitis.
The study's objective is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution (EGP-437) as compared to treatment with topically applied prednisolone acetate (1%) ophthalmic suspension eyedrops. In order to be enrolled into this multi-center randomized double-masked study, subjects need to be between 12 - 85 years of age with a diagnosis of non-infectious anterior uveitis, defined as an anterior chamber cell count of ≥ 11 cells. About two hundred patients were randomly assigned into one of two treatment arms in a 1:1 ratio. The primary efficacy endpoint evaluates the proportion of patients with anterior chamber cell count (ACC) of zero at Day 14. Safety will be assessed by the incidence and severity of adverse effects (AEs), and measures of intraocular pressure and best-corrected visual acuity. "Last Patient, Last Visit" is anticipated to be mid-February 2013. The company expects to have top-line data in the early Spring of 2013.
A previous Phase I/II study demonstrated that a single EGP-437 treatment, administered using iontophoresis, lowered ACC scores to zero (a complete response) in the majority of patients, caused only minor AEs, and no non-ocular systemic corticosteroid mediated side-effects were observed (Ophthalmology 119, 66 (2012)).
Principal study investigator Dr. John Sheppard of Virginia Eye Consultants said: "While corticosteroids are widely used as treatments for ocular inflammation such as uveitis, conventional 1% suspensions applied topically do not readily penetrate the intact ocular surface; therefore, they require frequent dosing in order to achieve and maintain adequate steroid levels. EyeGate's iontophoresis drug delivery approach has shown promise in reducing anterior chamber cell scores in patients with uveitis after a single treatment, suggesting that adequate levels of steroid are reaching the anterior segment of the eye. Since EyeGate's corticosteroid therapeutic is doctor administered, it circumvents the compliance issues associated with patient administered eye drop approaches. This clinical study should help determine the efficacy of EyeGate's corticosteroid formulation that is tailored for their innovative iontophoresis platform."
About Uveitis and Current Treatment Limitations
Uveitis is an inflammatory condition of the internal structures of the eye that can lead to cataract, glaucoma, scarring, pain, photophobia, and even permanent loss of vision when undiagnosed or treated poorly. Uveitis is a leading cause of blindness and is estimated to inflict 102 of every 100,000 adults in the U.S. per year.
Depending on the severity, standard management of uveitis consists of corticosteroid treatment applied either topically, by injection, systemically or a combination thereof. The principal means of regulating the dosage of a topically applied corticosteroid is to vary the frequency with which the medication is instilled. But the effectiveness of this regimen is often compromised due to poor patient compliance, inadequate dosing, or abrupt or rapid tapering schedules.
Ocular iontophoretic delivery of therapeutic agents has generated significant interest as a means of non-invasively achieving higher drug levels within the eye (by promoting the migration of a charged drug substance across biological membranes). The EyeGate® II Drug Delivery System (EGDS) is designed to provide adequate drugs levels of corticosteroids to the anterior segment of the eye more effectively than conventional treatment methods.
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 compact, elegant, and easy-to-use device that delivers drugs non-invasively and quickly into the ocular tissues, which can dramatically accelerate 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 1,700 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.