Feasibility Study Evaluating Safety and Efficacy of OTX-DP (Sustained Release Dexamethasone, 0.4mg) for Treatment of Dry Eye

This is a prospective, multi-center, randomized, parallel-arm, bilateral, double-masked,
vehicle controlled study to evaluate the safety and efficacy of OTX-DP compared to the
Placebo Vehicle (PV) for the treatment of subjects exhibiting signs and symptoms of dry eye
disease. This is a serial phase trial. Initially, the effect of the PV will be established
during a 6-week Punctum Plug Only Phase. This will establish baseline data to be used for
analysis of the Treatment Phase where subjects will be randomized to the study drug (OTX-DP)
or the placebo control (PV). Up to forty (40) subjects and eighty (80) eyes, who meet all
inclusion and none of the exclusion criteria will be asked to participate in this study.

Inclusion Criteria:

- Has a known history (within the past 6 months) of dry eye disease

- Has a corrected LogMAR VA ≤ 0.3 (20/40 Snellen or better) in each eye as assessed at
the Screening Visit

- Punctum Plug Only Phase: Minimal Cumulative (five areas) Corneal Fluorescein Staining
Score of 8 as assessed at the Screening Visit in each eye

- Treatment Phase: Minimal Cumulative (five areas) Corneal Fluorescein Staining Score of
5 as assessed on Day 1 (plug insertion) of the Treatment Phase in each eye

- Has an OSDI score of ≥18 as assessed at the Screening Visit

Exclusion Criteria:

- Any history of intraocular inflammation or its presence during the screening or
insertion slit lamp examination in either eye

- Active or a history of chronic/recurrent ocular or systemic disease that is
uncontrolled and will likely affect the study outcomes (e.g. iritis, uveitis,
viral/bacterial keratitis, viral/bacterial/allergic conjunctivitis, Rheumatoid
Arthritis, Crohn's disease, hepatitis C)

- Use of the following anti-inflammatory or immunomodulating agents (e.g. cyclosporine)
ocular or systemic for the duration of the study. Subjects will be allowed a maximum
washout period of 30 days from informed consent to PV plug insertion. Washout periods
for medications prior to plug only insertion are as follows: Systemic corticosteroids
- 4 weeks (Note: Systemic corticosteroids in inhaler or nasal spray form are not
exclusionary if they are used on a stable dosing regimen for at least 30 days prior to
Visit 1 and no change in the medication during the study period is anticipated);
Periocular injection of any corticosteroid solution - 3 months; Corticosteroid
intra-vitreal depot injection in either eye - 3 months; Ozurdex in either eye - 9
months; Retisert in either eye - 40 months; Topical ocular corticosteroid - 2 weeks;
Topical ocular NSAID - 7 days; Topical ocular or systemic cyclosporine - 1 month

- Has uncontrolled Glaucoma or is on medications to treat glaucoma

- Has ocular hypertension (Normalized IOP of ≥ 22 mmHg), is on medications to treat
ocular hypertension or has a history of IOP spikes in either eye

- Active or history of chronic or recurrent inflammatory eye disease (e.g. iritis,
uveitis)

- Active Epiphora

- Requires use of any topical ophthalmic solutions other than non-preserved OTC Tears
BID (maximum frequency) in the management of dry eye