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Barbara M Wirostko, Carol Marie Assang, Brenda Mann, Stephen From, Michael Raizman; Efficacy and safety of an Iontophoresis platform to control post cataract inflammation and pain. Invest. Ophthalmol. Vis. Sci. 2017;58(8):1081. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
To determine safety and efficacy of EGP-437 (dexamethasone phosphate solution) delivered via a novel and proprietary iontophoresis platform, the EyeGate II Delivery System, for managing post-surgical inflammation and pain.
This clinical study was conducted as an open label design with 7 active cohorts (N= 69 patients), varying the iontophoretic dose and dosing regimen as described in Table 1, receiving a 40 mg/ml solution of dexamethasone phosphate. An additional cohort (N=10 patients) received sodium citrate buffer as a placebo #8. Aqueous samples were collected from half of the patients (N=5) from cohort #7 at time of surgery to assess ocular bioavailability of the dexamethasone. The primary endpoint for all cohorts was Anterior Chamber Cell count (ACC) at day 14, with secondary endpoints of pain and intra-ocular pressure. Patients were followed for 28 days post-surgery.
The iontophoretic dose and treatment regimens for cohorts 2 and 6 resulted in a larger percentage of patients with an ACC of zero at day 14 (30% and 40%, respectively) compared to the placebo group (20%). At day 28, 80% of patients in cohort 2 and 70% in cohort 6 had an ACC = 0. In the placebo group, 80% of the patients had to be rescued prior to day 14. The aqueous samples from cohort 7 had 20.03 ± 8.53 ug/mL of total dexamethasone present. A majority of patients in cohorts 1-7 had a pain score of zero on day 1. Further, no elevation of IOP was noted in these cohorts and the delivery was well tolerated.
Iontophoretic delivery of EGP-437 was demonstrated to be a safe method to deliver adequate amounts of steroid into the ocular tissue to successfully manage post cataract inflammation and pain. This technology has the potential to eliminate the daily need for corticosteroid eye drops, thus leading to improved outcomes for this large patient population.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
Table 1: Cohort Dosing Regimen for EGP-437
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