Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema

Inclusion Criteria:

• Type 1 or Type 2 diabetes mellitus
• Diabetic Macular edema involving the center of the fovea in the study eye
• Best corrected visual acuity in the study eye between 34 and 78 (early treatment ofdiabetic retinopathy study) ETDRS letters

Exclusion Criteria:

• Macular edema is considered due to a cause other than diabetes mellitus in the studyeye
• Condition, in the study eye, in which visual acuity is not expected to improve fromthe resolution of macular edema
• Macular laser photocoagulation or panretinal laser photocoagulation in the study eyeperformed within 16 weeks prior to screening
• Active proliferative diabetic retinopathy (PDR) or sequelae of PDR in the study eye
• Prior treatment with anti-VEGF in the study eye:

1. Treatment naïve group (Part B), any IVT anti-VEGF treatments in the study eye areexclusionary regardless of the time interval since injection.
2. Previously treated group (Part A and B), subjects in the previously treated groupare excluded if they meet any of the below criteria for the study eye atscreening:
3. Subject has received less than 3 anti-VEGF injections since treatmentinitiation (at least three injections must have been received foreligibility).
4. Time interval between the first anti-VEGF injection and screening is morethan 40 weeks.
5. Last injection with ranibizumab or bevacizumab within 4 weeks prior toscreening.
6. Last injection with aflibercept within 8 weeks prior to screening.
7. Last injection with faricimab or brolucizumab within 12 weeks prior toscreening.
8. Prior treatment with SUSVIMO (Port Delivery System) implant is exclusionary.

• Prior ocular treatment with steroid injections (periocular, subtenon, intravitreal) orintravitreal implants in the study eye.
• Prior treatment with suprachoroidal steroids in the study eye is exclusionary.
• Active malignancy or history of malignancy within the past 5 years
• Uncontrolled diabetes with a hemoglobin A1c (HbA1c) more than 12% or any otheruncontrolled systemic disease at screening.