Additional Relevant Details
This portion of the trial enrolled 40 subjects that had previously undergone cataract surgery with the implantation of a posterior chamber intraocular lenses. The dose ascending trial was designed to assess the safety and efficacy of iontophoretic EGP-437 in these patients post cataract surgery. Patients were divided into four cohorts and administered iontophoretic EGP-437 at either 9mA-min or 14mA-min on Day 0, Day 1 and Day 2 or Day 0, Day 1 and Day 4, with potential for an additional treatment at Day 7 in all cohorts.A positive response, determined by reduction in Anterior Chamber Cell count (ACC) at day 28, was observed in the majority of patients in cohort 4. Subjects receiving the 14 mA-min dose at days 0, 1 and 4 demonstrated the most significant ACC improvement, with 40% of subjects in this cohort achieving an ACC count of 0 at day 14 which increased to 88% on day 28. Additionally, all subjects administered the iontophoretic treatment experienced reduction in pain at all time points with 90% having no pain as early as day 1 and increasing to 100% on day 14 again in this 14 mA-min cohort. Patients tolerated the procedure well and liked the idea of not using daily eyedrops. No steroid related increase in intraocular pressure was reported.