Duration 5min, Q&A 3min
Prospective, Multi-center, Randomized, Double-Masked, Phase 3 Pivotal Clinical Trial: Comparing the Safety and Efficacy of EGP-437 Iontophoresis Treatment to 1% Prednisolone Acetate Ophthalmic Suspension in Patients with Non-infectious Anterior Uveitis
This Phase 3 pivotal clinical study compared the safety and efficacy of ocular iontophoresis with EGP-437 to positive control prednisolone acetate, PA, in patients with non-infectious anterior uveitis.
193 subjects with a diagnosis of non-infectious anterior segment uveitis, 11 or more cells in the AC, from 36 centers across the USA enrolled. Study medications were: EGP-437, which is dexamethasone phosphate formulated for iontophoresis, using the EyeGate II Drug Delivery System and 1% PA ophthalmic suspension.
The study included five visits over eight weeks. Day 0, subjects meeting all inclusion and no exclusion criteria were randomized into one of two study treatment arms in a 1:1 ratio: 96 subjects received EGP-437 treatment, 4.0 mA-min at 1.5 mA, on Days 0 and 7 and self-administered placebo drops from Day 0 to 28. 97 subjects received placebo iontophoresis treatment, 4.0 mA-min at 1.5 mA, on Days 0 and 7 plus self-administered PA eye drops from Day 0-28. Regimen: 8 per day week 1, 6 per day week 2, 4 per day weeks 3 and 4. Patients returned to clinical sites on Days 14, 28, and 56 for safety and efficacy evaluations. At all study visits, acuity, AC cell count and score, and IOP were evaluated. Study assessments included: slit-lamp biomicroscopy, AC cell count and score; IOP measurement; BCVA; fundus examination; ocular signs and symptoms.
Results and Conclusion
The primary efficacy endpoint in this non-inferiority study compared the difference in treatment response rates between two treatment arms: the proportion of patients with AC cell count of zero on Day 14, which was defined as a complete response. In the Intent-to-Treat ITT population, two separate EGP-437 treatments on Days 0 and 7 resulted in 32/96 complete responses at Day 14; while PA produced 32/97 complete responses over the first 14 days. In the Per Protocol PP population, two separate iontophoretic treatments of 4.0 mA-min at 1.5 mA with EGP-437 on Days 0 and 7 resulted in 31/82 complete responses on Day 14; while PA produced 31/87 complete responses. The number of subjects who experienced a TEAE or Treatment Emergent Adverse Event, the incidence of TEAEs, and the distribution of TEAE severity in both groups were comparable. Two iontophoresis treatments with EDP-347 caused no significant IOP elevations. Iontophoretic delivery of dexamethasone is safe and effective in the treatment of non-infectious anterior uveitis and can become an important new componenent of the anti-inflammatory algorithm.
[ Keyword ]
uveitis / iontophoresis / dexamethasone / drug delivery / glaucoma
[ Conflict of Interest ]
[ Conflict of Interest (Potential conflict) ]
Stephen From and Michael A. Patane are employees of EyeGate Pharmaceuticals, Inc. John D. Sheppard is a consultant to and clinical investigator for EyeGate Pharmaceuticals, Inc.