A Prospective, Multi-Center, Randomized, Double-Masked, Positive-Controlled Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspension (1%) in Patients With Non-Infectious Anterior Segment Uveitis
Anterior uveitis is a disorder of the eye associated with intraocular inflammation of the
anterior portion of the uvea, particularly the iris and/or ciliary body. It is distinct from
other iterations of uveitis such as posterior, diffuse and intermediate uveitis although it
is the most common form of uveitis and accounts for approximately 75% of cases.
In a Phase 1/2 study (EGP-437-001), the delivery of EGP-437 (40 mg/mL dexamethasone
phosphate solution) at four different iontophoresis dose levels was studied in 40 subjects
with non-infectious anterior segment uveitis. The study demonstrated that a single EGP-437
treatment: lowered anterior chamber cell (ACC) scores in the majority of patients without
requiring additional treatment; produced low short-term systemic exposure to dexamethasone
and dexamethasone phosphate; and produced the most beneficial effects in the 1.6 and 4.8
mA-min dose groups; and caused mainly minor AEs and no non-ocular systemic corticosteroid
mediated effects were observed.
The Phase 3 study is intended to confirm and extend the results from the Phase 2 study. The
study is designed to assess the safety and efficacy Ocular Iontophoresis with EGP-437 4.0
mA-min at 1.5 mA and accompanying placebo eyedrops in comparison to Ocular Iontophoresis
with sodium citrate buffer solution 4.0 mA-min at 1.5 mA and accompanying prednisolone
acetate (1%) eyedrops for the treatment of non-infectious anterior segment uveitis.