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 use contraception; * At least one eye with moderately severe to severe NPDR (DRSS levels 47 or 53) or mild PDR (DRSS level 61); * Patients with or without diabetic macular edema (DME) may be eligible if they meet protocol 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 Snellen equivalent 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 not required 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 who are 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 laser photocoagulation or Pan-Retinal Photocoagulation (PRP); * History of previously treated DME with f…