SYL040012, Treatment for Open Angle Glaucoma

A Phase II, Observer Masked, Active Controlled Study of SYL040012 for the Treatment of Elevated Intraocular Pressure in Patients With Open-angle Glaucoma or Ocular Hypertension

The purpose of this double-masked, randomized, controlled study is to assess the safety and ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated intraocular pressure.

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