EyeGate Pharma has enrolled the first patient in a Phase III pivotal study of its EGP-437 product, a late-stage asset with multiple indications for inflammatory ocular indications used to treat anterior uveitis.
EGP-437 is a dexamethasone derived corticosteroid solution, formulated for delivery using the EyeGate II system, a non-invasive iontophoretic drug-delivery technology.
The Phase III, randomised, double-masked and positive-controlled non-inferiority trial will involve up to 200 people and will be conducted at more than 20 sites in the US. It will evaluate the efficacy of EGP-437 in comparison with topically applied prednisolone acetate eye drops.
Study investigator Joseph Tauber said that prior Phase II data suggest that EGP-437, when delivered using the EyeGate II drug delivery system, could lead to a better predictable clinical response and has the potential to improve the way anterior uveitis is treated.
EyeGate Pharma president and CEO Stephen From said that the company was committed to eliminating the compliance issues that corneal specialists and patients struggle with when treating serious inflammatory episodes.
Earlier Phase II study reported that EGP-437 demonstrated improvements in the signs and symptoms of dry eye during and after controlled adverse experiment exposure, and about two-thirds of the patients reached an anterior chamber cell score of zero within 28 days, after only receiving one iontophoresis treatment.
The company expects to report Phase III anterior uveitis study data by the end of this year, and plans to commercially launch EGP-437 as early as the end of 2013 for anterior uveitis.
EGP-437 has been granted orphan drug designation by both the Food and Drug Administration and European Medicines Evaluation Agency for corneal graft rejection.
EyeGate also announced that it has secured an additional $5.9m as part of its Series D closing, to advance development of EGP-437 for the treatment of dry eye syndrome.