AUG 03, 2016
Top-line data from EyeGate Pharmaceutical’s 1b/2a trial suggests that administering a glucocorticoseroid through transscleral iontophoresis can safely treat inflammation and pain following cataract surgery.
The EyeGate II Delivery System offers an alternative to postoperative eye drops, using an applied electrical field to drive an iontophoretic glucocorticoseroid through the sclera, delivering substantially higher ocular drug concentrations than traditional topical applications, leading to greater bioavailability and more sustained therapeutic effect and reducing the frequency of dosing.
“Cataract surgery patients, many of whom are older, may have difficulty instilling eyedrops and thus adhering to the current post-surgical standard of care, a topical corticosteroid eyedrop,” said Barbara Wirostko MD, Chief Medical Officer of EyeGate. “We believe that iontophoretic EGP-437 administered by the surgeon has the potential to significantly reduce adherence burden and dramatically improve patient outcomes.”
In this early trial, 40 cataract patients received either 9 mA-min or 14 mA-min of the dexamethasone phosphate formulation (EGP-437) on postop day 0, day 1 and day 2 or day 0, day 1 and day 4. The cohort assigned the higher dose for days 0, 1 and 4 showed the best response, as measured by anterior chamber cell count (ACC). By day 14, 40% of the group demonstrated an ACC count of 0, increasing to 88% on day 28.
All patients receiving the 14 mA-min dose (on either schedule) reported reduction in pain at all time points, 90% had no pain by day 1 and 100% were pain-free by day 14. The treatment was well tolerated, and no steroid-related increase in IOP was found.
Data from the trial’s additional cohorts is expected in the fourth quarter of 2016. EyeGate is forecasting a randomized, placebo-controlled trial by the end of the year.