Study Assessing AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)

AR-1105 is a dexamethasone containing implant drug delivery system that is injected into the
back of the eye. It is designed to dissolve slowly over time, continuously releasing a
consistent low dose of steroid to treat the symptoms of RVO and associated inflammation with
a goal of halting further visual disturbance and damage, and also possibly restoring some
vision as symptoms are controlled. In this study, 2 different formulations are being tested
to find the optimum combination of efficacy, safety and durability that will offer patients a
potential treatment option that is as safe and effective as the treatments currently
available, but which requires less frequent injections and potentially has a lower risk for
certain side-effects.

Inclusion Criteria:

1. At least 18 years of age

2. Vision loss due to clinically detectable macular edema (ME) associated with either
central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO).
Subjects may be treatment-naïve, or if previously-treated with a steroid, must have
demonstrated response to treatment

3. Duration of macular edema (ME) ≥9 months in subjects with CRVO and ≥12 months in
subjects with BRVO. If both eyes are eligible, the study eye will be the eye with
worse VA

4. Best-corrected visual acuity (BCVA) as measured by the early treatment of diabetic
retinopathy study (ETDRS) methodology of between 25 and 70 letters, in the study eye
and better than 35 letters, in the non-study eye

5. Retinal thickness in the central subfield of >290 µm (females) and >305 μm (males) if
using a Cirrus (Zeiss) instrument, or if a Spectralis (Heidelberg) instrument is used,
thickness should be >305 μm (females) or >320 μm (males) in the study eye

6. Be able to understand and willing to provide written informed consent.

7. Be willing and able to adhere to the instructions set forth in the study protocol

Exclusion Criteria:

Ophthalmic:

1. Presence of a clinically significant epiretinal membrane, active retinal or optic disc
neovascularization, active or history of choroidal neovascularization, presence of
rubeosis iridis

2. History or presence of herpetic infection, toxoplasmosis, chorioretinopathy.

3. Subjects with moderate non-proliferative diabetic retinopathy or worse in either eye
are excluded from participation

4. Any active infection

5. Aphakia, significant posterior capsule tear or iris trauma in the study eye

6. Anterior-chamber intraocular lens

7. Clinically significant media opacity

8. History of glaucoma or visual field loss

9. Ocular hypertension in the study eye at qualification, (with or without treatment)

10. History of corticosteroid-induced IOP increase in either eye

11. Ocular condition in the study eye that, in the opinion of the investigator, would
prevent a 15-letter improvement in visual acuity

12. Received an intraocular steroid injection or implant within 6 months or any anti-VEGF
treatment within 2 months prior to screening. Prior treatment with RETISERT® or
ILUVIEN® or pan-retinal photocoagulation (PRP) is exclusionary

13. Intraocular surgery (including laser refractive or eyelid surgery) within 3 months
prior to Visit 1 or anticipated need for ocular surgery or ophthalmic laser treatment
during the study treatment period

14. Currently using topical corticosteroids in the vicinity of the eyes within the 1 month
prior to Visit 1

15. Periocular depot of steroids placed within 6 months prior to qualification

16. Ocular medications that are specifically disallowed in this protocol for any condition
during the study or within the specified timeframe prior to Visit 2

17. Have progressive optic nerve disease or retinal disease other than retinopathy due to
RVO that affects BCVA

Systemic:

18. Currently using or anticipating the use of systemic corticosteroids during the study
(with the exception of inhaled, intranasal or topical corticosteroids)

19. Any clinically significant or uncontrolled serious or severe medical or psychiatric
condition

20. Participation in any other clinical study within 30 days prior to Visit 1

21. History of hypersensitivity or poor tolerance to any components of the preparations to
be used in this study such as dexamethasone or biodegradable polymer (PLGA) excipients
or fluorescein

22. Systemic condition that may confound the study outcome per the investigator's opinion

23. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or
not using a medically acceptable form of birth control