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EyeGate Announces Encouraging Interim Data from Phase 1b/2a Clinical Trial of EGP-437 for Treatment of Ocular Inflammation and Pain Post Cataract Surgery

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Additional Relevant Details The ongoing Phase 1b/2a clinical trial is a multi-center, open-label trial enrolling up to 50 subjects who have undergone unilateral cataract extraction and implantation of a monofocal intra-ocular lens. The primary objective of this trial is to assess the safety and efficacy of iontophoretic EGP-437 in these patients following surgery. The trial design includes 5 cohorts whereby iontophoretic doses of 4.0 mA-min, 9.0 mA-min and 14.0 mA-min were employed and the 9.0 and 14.0 mA-min cohorts included 2 different dosing regimens. Subjects in the 9.0 and 14.0 mA-min cohorts had three treatments administered 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. The primary endpoint for all cohorts is ACC at day 14, with secondary endpoints measuring pain score and intra-ocular pressure.A positive response was observed in the majority of the patients, with some patients in 9.0 and 14.0 mA-min cohorts presenting with ACC of zero at day 14 and others presenting with trace ACC levels. Additionally, all subjects experienced low pain throughout the duration of the trial.Enrollment will continue for the remaining cohorts with additional planning for next steps; including additional clinical development work to determine the optimal dose and dosing regimen. A double-masked, prospective randomized, controlled trial is expected to initiate by the end of 2016.
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Occurred on:
Jun 01, 2016
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Related Keywords Egp-437, Phase 1b/2a, Interim Data, Ocular Inflammation, Pain Post Cataract Surgery, Cataract Surgery, Iontophoretic Egp-437