SYL040012, Treatment for Open Angle Glaucoma

Inclusion Criteria:

- Patients older than 18 years of either sex

- Good or fair general health as assessed by the investigator.

- Signed informed consent prior to any clinical trial-related procedures

- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)

- Post-washout mean IOP above target range

- BCVA 1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200)

- Stable visual field

- Central corneal thickness 480-620 μm

- Shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes

Exclusion Criteria:

- Pregnant or breastfeeding females

- Females of childbearing potential not willing to use a medically acceptable
contraceptive method

- Clinically significant systemic disease

- Changes of systemic medication that could have a substantial effect on IOP

- Known hypersensitivity to any component of the formulations

- Unable to comply with the clinical trial requirements

- Clinically significant abnormalities in laboratory tests

- Severe visual field defect

- Any secondary glaucoma

- Pseudoexfoliation or pigment dispersion component, history of angle closure or narrow
angles.

- IOP ≥ 35 mm Hg in any eye

- Previous non-laser glaucoma surgery or glaucoma laser procedures (e.g., laser
trabeculoplasty) and refractive surgery

- Any ocular surgery or laser treatment, cataract extraction or ocular trauma within 6
months prior to Baseline

- Evidence of ocular infection, inflammation, clinically significant blepharitis or
conjunctivitis at baseline (Visit 0), or a history of herpes simplex keratitis

- Clinically significant ocular disease