A Safety Study of of AG-920 Sterile Topical Ophthalmic Solution

A Phase 3, randomized, placebo-controlled, double-masked, parallel study in healthy subjects performed in the US. It is designed to evaluate the ocular safety of one dose of AG-920 compared to placebo. I). In this study, subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 2:1 ratio to receive one dose of AG-920 or identical looking placebo into one (study) eye. A subset of subjects will undergo endothelial cell count (ECC) evaluations.

Each dose of AG-920 or placebo will consist of two drops in the study eye. After the completion of dosing, subjects will undergo a series of eye exams that will be documented. Investigational medicinal product (IMP) dosing will be performed by the study staff.

Inclusion criteria

• Provide written informed consent prior to any study-related procedures being performed.
• Male or a non-pregnant, non-lactating female.
• Healthy by clinical assessment, including ocular examination.
• Have an Early Treatment of Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) of 20/200 or better in both eyes.
• Have an Intraocular Pressure (IOP) between 7 and 30 mmHg.

Specular microscopy subset subjects only:

• Have a central corneal endothelial cell density of ≥1500 cells/mm2 at baseline

Exclusion criteria

• . Have participated in an investigational study within the past 30 days.
• Have a contraindication to local anesthetics, Septocaine®, or any component of the IMP.
• Have had ocular surgery or general surgery in either eye within the past 90 days.
• Have had an intravitreal injection in either eye within 14 days of randomization.
• Have ocular surface disease requiring punctal plugs.
• Have evidence of any current ocular inflammation.
• Current ocular allergy symptoms.
• Have used topical, ocular medications in the 24 hours preceding dosing.
• Systemic opioid, opiate analgesic or topical Non-steroidal Anti-Inflammatory Drug (NSAID) use within the past 30 days.
• Previous participation in a clinical study of AG-920.
• A current condition which could cause vision problems such as Pseudotumor Cerebri.