Study of Safety and Tolerability of EO2002 in the Treatment of Corneal Edema

The study is designed to occur in 2 groups. The objective with the first group is to preliminarily evaluate the safety of 4 escalating doses. The purpose of the second group is to gather additional safety information on the 3 highest doses when administered according to a randomized schedule and evaluated by masked observers.

Group 1: Phase 1 prospective, multi-center, open-label, dose-escalation study designed to evaluate the safety and tolerability of EO2002 with and without endothelial brushing (EB) or Descemet Stripping (DS) in eyes with corneal edema secondary to corneal endothelial dysfunction that qualify for surgery involving full-thickness corneal transplantation or EK. Four doses will be studied in approximately 21 study participants that meet the inclusion/exclusion criteria. Safety and tolerability will be the primary focus for 26 weeks following treatment with EO2002.

Group 2: The three highest doses will be administered to up to 21 subjects in a randomized, double-masked design.

Inclusion criteria

All ocular criteria apply to study eye unless otherwise noted.

• Age ≥ 21 years.
• Phakic or Pseudophakic with a posterior chamber intraocular lens
• Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs corneal dystrophy or pseudophakic bullous keratopathy.

Exclusion criteria

All ocular criteria apply to study eye unless otherwise noted.

• Other corneal disease
• Anterior chamber intraocular lens, Sutured or scleral-fixated intraocular lens.
• Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
• History of refractive surgery.
• Descemet membrane detachment.
• History of uveitis or other ocular inflammatory disease.
• History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage implant).
• Intraocular pressure >21 or <7 mm Hg
• Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.
• History of ocular neoplasm.
• ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).
• Female who is pregnant, nursing, or planning to become pregnant, or who is of childbearing potential and not using a reliable means of contraception during the study.
• Subject is currently participating in or has participated within the last 3 months in any other clinical trial of an investigational drug by ocular or systemic administration.
• Any concomitant medical or psychological condition that could interfere with study participation or is otherwise not suitable for entry into the study in the opinion of the investigator.