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news.EyeGate Pharma has enrolled the last patient for its pivotal phase III study of EGP-437 in patients with anterior uveitis.
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The study aims to compare the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution (EGP-437) in relation to topically applied prednisolone acetate (1%) ophthalmic suspension eyedrops treatment.
The study carried out on nearly two hundred patients assigning them into one of two treatment arms in a 1:1 ratio.
The primary efficacy endpoint will assess the proportion of patients with anterior chamber cell count of zero at Day 14.
The safety of EGP-437 will be evaluated by the incidence and severity of adverse effects and measures of intraocular pressure as well as corrected visual acuity.
The company expects to receive the results in the early Spring of 2013.
Virginia Eye Consultants principal study investigator John Sheppard said ‘EyeGate’s iontophoresis drug delivery approach has reduced anterior chamber cell scores in patients with uveitis after a single treatment, showing that adequate levels of steroid are reaching the anterior segment of the eye.
”This clinical study should help determine the efficacy of EyeGate’s corticosteroid formulation that is tailored for their innovative iontophoresis platform." Sheppard added.
Uveitis is an inflammatory condition of the internal structures of the eye, which can cause cataracts, glaucoma, scarring, pain, photophobia as well as permanent loss of vision when undiagnosed or treated poorly.