Exploratory Study of KPI-121 Effect on Intra- or Subretinal Fluid Due to Retinal Vein Occlusion/Diabetic Macular Edema

This is a multicenter, randomized, single-masked study evaluating the safety and effect of
topical ocular administration of either KPI-121 0.25% ophthalmic suspension or KPI-121 1.0%
ophthalmic suspension in subjects with intraretinal or subretinal fluid secondary to Retinal
Vein Occlusion or Diabetic Macular Edema.

Inclusion Criteria:

- Have documented presence of intraretinal or subretinal fluid secondary to Retinal Vein
Occlusion or Diabetic Macular Edema at Screening

Exclusion Criteria:

- Treatment with topical, intravitreal injection, posterior sub-Tenon's, or periocular
corticosteroids within 120 days prior to Visit 1 and for the duration of the study

- History of uncontrolled glaucoma, IOP over 21 mmHg at Visit 1, or are being treated
for glaucoma in the study eye

- Any significant ocular disease that could compromise vision in the study eye
(including ongoing ocular infection, wet age-related macular degeneration, myopic
degeneration with active subfoveal choroidal neovascularization)

- Known hypersensitivity or contraindication to the investigational product(s) or their
components

- Diagnosis of severe/serious ocular condition that in the judgment of the Investigator
could confound study assessments or limit compliance; or severe/serious systemic
disease or uncontrolled medical condition that in the judgment of the Investigator
could confound study assessments or limit compliance

- Exposed to an investigational drug within 30 days prior to Visit 1 and for the
duration of the study

- In the opinion of the Investigator or study coordinator, an unwillingness or inability
to comply with the study protocol or inability to successfully instill eye drops