TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)

Part 1 is a randomized, double-maskedtrial trial designed to investigate the use of TLC399 in
subjects with macular edema due to CRVO or BRVO. Three different dose strengths will be
evaluated.

Part 2 is a randomized, double-masked study designed to evaluate 2 doses of TLC399 in
subjects with macular edema due to CRVO or BRVO. Subjects will be randomized 1:1 to receive
two different dose strenghs of investigational product.

Inclusion Criteria:

1. male or female, at least 18 years of age

2. macular edema due to CRVO or BRVO

3. best-corrected visual acuity (BCVA) score of 20/40 to 20/400

4. mean central subfield thickness (CST) ≥350 um

5. willing and able to comply with the study procedure and sign a written informed
consent

6. agree to use a medically acceptable form of birth control

Exclusion Criteria:

1. poorly controlled diabetes

2. history of significant intraocular pressure (IOP) elevation to steroid treatment

3. history of ocular hypertension and glaucoma

4. cataract surgery in the study eye within 3 months, or intraocular surgery within 6
months prior to screening

5. use of hemodilution for the treatment of RVO

6. use of IVT ranibizumab or bevacizumab in the study eye within 6 weeks prior to
screening; or IVT aflibercept within 8 weeks prior to screening

7. IVT Ozurdex to the study eye within 6 months prior to screening

8. prior use of Retisert or Iluvien

9. use of systemic steroids or heparin within 1 month prior to screening