A Multi-Center Study Subjects With Dry Eye Syndrome

- To investigate the safety and tolerability of EBI-005 ophthalmic solution compared to
placebo in the treatment of patients with moderate to severe Dry Eye Syndrome (DES).

- To evaluate pharmacokinetic (PK) parameters and immunogenicity of two different doses
of EBI-005 ophthalmic solution.

- To investigate the biological activity of multiple doses of EBI-005 ophthalmic solution
compared to placebo as assessed by both objective and subjective assessments.

- To investigate the comparative dose response of two different doses of EBI-005
ophthalmic solution.

- To investigate the comparative tolerability of two different doses of EBI-005
ophthalmic solution.

- To identify key biomarkers in the diagnosis and management of subjects with DES.

Inclusion Criteria:

- Provide written informed consent prior to any study related procedures

- Are 18 years of age or older

- Are women of child bearing potential (WOCBP) who are non-pregnant, non-lactating and
sexually inactive (abstinent) for 14 days prior to Visit 1

- Are willing and able to follow instructions and can be present for the required study
visits for the duration of the study

- Have a history of Dry Eye Syndrome in both eyes supported by a previous clinical
diagnosis

- Have ongoing Dry Eye Syndrome, in the same eye or both eyes, as defined by the
following criteria:

1. A score of ≥23 on OSDI

2. A corneal fluorescein staining score of ≥6 (NEI scale)

- Have normal lid anatomy

- Are willing to withhold artificial tears for the duration of the study, with the
exception of the study provided artificial tears: Refresh Plus®.

Exclusion Criteria: Subjects may not:

- Have previously used an IL-1 blocker (e.g., Anakinra, Rilonacept or Ilaris).

- Have an OSDI score ≥90

- Have a corneal fluorescein staining score of 15 (NEI scale). NOTE: If one of two eyes
has a corneal fluorescein staining score of 15, the subject may be eligible.

- Within 30 days prior to the screening visit (Visit 1) have taken: Topical
cyclosporine (Restasis®) Ocular corticosteroids Autologous serum Topical ocular
antibiotics Topical ocular antihistamines or mast cell stabilizers Topical or nasal
vasoconstrictors

- Within 30 days prior to the screening visit (Visit 1) have altered the dose of
tetracycline compounds (tetracycline, doxycycline or minocycline).