EGP-437 is formulated for delivery using the EyeGate II drug delivery system, a non-invasive iontophoretic drug delivery technology.
The Phase III randomized double-masked positive-controlled non-inferiority trial is expected to enroll around 200 subjects to investigate the efficiency of EGP-437 in comparison to topically applied prednisolone acetate eye drops.
EyeGate Pharma president and CEO Stephen From said the positive Phase II trial data led to the commencement of Phase III study, which they hope will demonstrate treatment benefits over traditional treatments with prednisolone acetate.
Both Food and Drug Administration and European Medicines Evaluation Agency for corneal graft rejection has granted orphan drug designation to EGP-437.
The company plans to present Phase III anterior uveitis study data by the end of this year, and to commercially launch EGP-437 as early as the end of 2013 for anterior uveitis.