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EyeGate Pharma begins EGP-437 drug trial

EyeGate Pharma has commenced patient enrollment in a Phase I study investigating the safety and effectiveness of its lead product, EGP-437 (dexamethasone phosphate formulated for iontophoresis).

The randomized double-masked placebo-controlled trial will recruit around 24 subjects with non-infectious, non-necrotizing anterior scleritis to assess the safety and tolerability of three ocular iontophoresis dose levels of EGP-437.

EGP-437 will be administered using the EyeGate II ocular drug delivery system, a non-invasive, iontophoretic drug-delivery technology.

The study is being partially funded by an FDA orphan drug indication grant, which allows enrollment at The University of Pennsylvania School of Medicine and The Wilmer Ophthalmological Institute in Baltimore, Maryland, US.

In addition, supplemental funding by EyeGate Pharma will expand the study to four additional sites.

University of Pennsylvania School of Medicine professor John Kempen said they look forward to testing and evaluating EyeGate’s iontophoretic drug delivery technology for the treatment of anterior scleritis.

The first pivotal Phase III anterior uveitis study of EGP-437 was started in January 2012, and the top line data are anticipated by the end of this year.

EGP-437 is likely to be launched as early as the end of 2013 for anterior uveitis.

Both FDA and European Medicines Evaluation Agency for corneal graft rejection granted orphan drug designation for EGP-437.