Open-label, Multli-center, Phase 1b/2a Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients With Macular Edema

This will be a Phase 1b/2a, exploratory, open-label study, in which up to 20 eligible ME
patients will be enrolled at up to 5 clinical sites in the U.S. Twenty eyes of 20 patients
will be enrolled which means that only one eye will be treated with study treatment in
patients who present at Visit 1 with bilateral ME. In situations where both eyes of a
patient are eligible for the study, the eye with the shorter duration of ME will be the
study eye.9 The investigator will designate the study eye when both eligible eyes have been
diagnosed with ME at the same time. Potential patients who are interested in participating
in the study will be provided an informed consent form (ICF) prior to screening. Patient
eligibility will be assessed at Visit 1 (Day 0), the baseline visit, by spectral SD-OCT and
measurement of IOP, in addition to review of the patient's medical and ophthalmic history
and recent concomitant medications history. Study Treatment will be administered on Day 0,
Day 4, and Day 9 (Visits 1, 2, and 3). Subjects will be scheduled to return to the clinic
for post-treatment assessments during Visits 4 and 5 (Day 14 and Day 21 or Day 28).

Inclusion Criteria:

- 1. Age 18 to 90 years 2. Have diagnosis of ME secondary to one of the following
diagnosed conditions:

1. Central or branch retinal vein occlusion (CRVO or BRVO) with a mean CST ≥ 300µm
on SD-OCT images taken at the baseline visit (Day 0)

2. Diabetic macular edema (DME) with a mean CST ≥ 300µm on SD-OCT images taken at
the baseline visit (Day 0)

3. Cystoid macular edema (CME) secondary to having undergone a previous PPV and
having a mean CST ≥ 300µm on SD-OCT images taken at the baseline visit (Day 0)
having a history of previous positive response to steroid treatment 3. Receive,
understand, and sign a copy of the ICF 4. Be able to return for all study visits
and willing to comply with all study related instructions

Exclusion Criteria: