title: Evaluation of dexamethasone phosphate delivered by ocular iontophoresis for treating noninfectious anterior uveitis.
abstract: OBJECTIVE
  Determine safe, effective, iontophoretic dose(s) of EGP-437 (dexamethasone phosphate formulated for iontophoresis) in patients with noninfectious anterior uveitis; evaluate systemic drug exposures.
  
  
  METHODS
  Prospective, phase I/II, multicenter, double-masked, parallel group, randomized clinical trial.
  
  
  METHODS
  Forty outpatients with anterior uveitis.
  
  
  METHODS
  Forty of 42 randomized patients received an iontophoresis treatment in 1 qualifying eye and completed the study. Patients were randomized into 1 of 4 iontophoresis dose groups (1.6, 4.8, 10.0, or 14.0 mA-min), treated with EGP-437 via the EyeGate II Delivery System (EGDS), and followed until day 28.
  
  
  METHODS
  The main outcome measures were anterior chamber cell (ACC) scores at days 14 and 28; time to ACC score of zero; proportion of patients with an ACC score reduction from baseline of ≥ 0.5 at day 28; mean change from baseline in ACC score at day 28; and the systemic exposures of dexamethasone and dexamethasone phosphate after EGP-437 treatment with the EGDS.
  
  
  RESULTS
  After a single EGP-437 treatment, 19 of 40 patients (48%) achieved an ACC score of zero at day 14. By day 28, 24 of 40 patients (60%) achieved an ACC score of zero. A Kaplan-Meier analysis demonstrated that the 1.6 mA-min dose was the most effective and revealed an inverse dose response; median days to an ACC score of zero were 11.5 days in the 1.6 mA-min group versus 31 days in the 14.0 mA-min group. Twenty-six patients (65%) had an ACC score reduction from baseline of ≥ 0.5 at day 28. The mean change in ACC score from baseline to day 28 was -2.14 with a median of -2.00. Throughout the study, the mean intraocular pressure remained within normal range and mean best-corrected visual acuity at 4 meters remained relatively stable. Most adverse events were mild; no serious adverse events were reported. Pharmacokinetics results showed low short-term systemic exposure to dexamethasone after iontophoresis; no nonocular systemic corticosteroid-mediated effects were observed.
  
  
  CONCLUSIONS
  Approximately two thirds of the patients reached an ACC score of zero within 28 days, after only receiving 1 iontophoresis treatment. The lower doses seemed to be the most effective, and treatments were well-tolerated.
  
  
  BACKGROUND
  Proprietary or commercial disclosure may be found after the references.
authors: Eyegate Pharmaceuticals, Inc, Waltham, Massachusetts 02453, USA.
authors: Amy E
authors: AE
authors: Cohen
authors: Carol
authors: C
authors: Assang
authors: Michael A
authors: MA
authors: Patane
authors: Stephen
authors: S
authors: From
authors: Michael
authors: M
authors: Korenfeld
mesh_terms: D000328:Adult; D000368:Aged; D003907:Dexamethasone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007478:Iontophoresis; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D014606:Uveitis, Anterior / Q000188:drug therapy* / Q000503:physiopathology; D055815:Young Adult
chemical_list: D005938:Glucocorticoids; C004180:dexamethasone 21-phosphate; D003907:Dexamethasone