Ocular inflammation drug in phase I study

Waltham, MA-EyeGate Pharma has begun enrolling patients with anterior scleritis into a phase I study evaluating the safety and effectiveness of its lead product, dexamethasone phosphate ophthalmic solution 40 mg/ml (EGP-437), which the company believes has multiple indications for inflammatory ocular indications.

The randomized, double-masked, placebo-controlled study will evaluate the safety and tolerability of three ocular iontophoresis dose levels of the solution in subjects with non-infectious, non-necrotizing disease. The drug will be administered using the company’s proprietary non-invasive, iontophoretic drug-delivery technology (EyeGate II Ocular Drug Delivery System). Through iontophoresis, an electrical field generated by a low-level electrical current promotes the movement of charged substances (drug products) across biologic membranes, allowing for drug 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 John H. Kempen, MD, MHS, MPH, PhD, of the University of Pennsylvania’s Perelman School of Medicine, Philadelphia. The grant funds enrollment at two clinical sites: Penn and the Wilmer Eye Institute in Baltimore.

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 EyeGateʼs iontophoretic drug delivery technology for the treatment of anterior scleritis,” Dr. Kempen said. “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,” said Stephen From, president and chief executive officer of EyeGate Pharma.

“Intraocular injections are an alternative treatment to eye drops; however, the injections introduce substantial risks to patients,” he added. “We remain committed to eliminating the compliance issue and providing a safer alternative to treating serious inflammatory episodes.”

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