EyeGate Pharma, a privately held specialty pharmaceutical company developing a non-invasive ocular drug delivery platform and ocular therapeutics, has enrolled last patient in the pivotal phase III study of EGP-437 in patients with anterior uveitis. The objective of study 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 (one per cent) ophthalmic suspension eyedrops.

The company expects to have top-line data in the early Spring of 2013.

In order to be enrolled into this multi-centre 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.

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 one per cent 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.”

Uveitis is an inflammatory condition of the internal structures of the eye that can lead to cataracts, glaucoma, scarring, pain, photophobia, and even permanent loss of vision when undiagnosed or treated poorly.

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.

Eyegate Pharmaceuticals, Inc. is focused on developing therapeutics designed to address two major issues in ophthalmic medicine, patient compliance and patient throughput.