Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy

Inclusion Criteria

• Adults ≥ 18 years;

• Diabetes mellitus (type 1, type 2 or other forms);

• Females who are not a woman of childbearing potential (WOCBP) or who agree to usecontraception;

• At least one eye with moderately severe to severe NPDR (DRSS levels 47 or 53) ormild PDR (DRSS level 61);

• Patients with or without diabetic macular edema (DME) may be eligible if they meetprotocol specified eligibility criteria;

• Best corrected visual acuity (BCVA) early treatment of diabetes retinopathy study (ETDRS) letter score in the study at screening ≥69 letters (approximate Snellenequivalent of 20/40 or better) without CI-DME, or ≥75 letters when CI-DME is present (approximate Snellen equivalent 20/32 or better);

• Anti-vascular endothelial growth factor (VEGF) or any laser treatment is notrequired nor anticipated in the study eye for least 6 months.

Exclusion Criteria:

• Body mass index ≥ 45 kg/m2

• Uncontrolled diabetes mellitus such as hemoglobin A1c (HbA1C) > 11% or patients whoare not currently treated for their diabetes;

• Uncontrolled hypertension defined as systolic > 160mmHg or diastolic > 100 mmHg (despite hypertensive medication);

• Proliferative Diabetes Retinopathy (PDR) with the exception of mild PDR (DRSS 61);

• Evidence of retinal neovascularization (with the exception of mild PDR);

• Any previous Diabetic Retinopathy treatment with focal or grid laserphotocoagulation or Pan-Retinal Photocoagulation (PRP);

• History of previously treated DME with fluocinolone acetonide implant (Iluvien®)injection;

• Visual acuity loss due to an ocular condition that would not improve from treatmentof DR or resolution of DME (i.e., foveal atrophy, pigment abnormalities, densesubfoveal hard exudates, nonretinal condition);

• History of vitreoretinal surgery;

• Intraocular surgery in the study eye within 3 months of randomization or anticipatedover the course of the study;

• Uncontrolled glaucoma (e.g. visual field loss or defined as (IOP) ≥ 25 mmHg despitetreatment with anti-glaucoma medication);

• Evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitisin either eye /any intraocular inflammation or infection in either eye within 3months prior to randomization.