Effect of AIV007 by Periocular Administration in Subjects with Macular Edema Secondary to Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)

Inclusion Criteria:

General inclusion Criteria:

1. Male or female subjects aged 21-90 years (inclusive) at screening

2. BCVA in the study eye at screening and baseline/Day 1: ETDRS letter score ≤ 75 and ≥ 24 (20/32 to 20/330 Snellen equivalent)

3. Subject must have received treatment within the 24 months before screening withintravitreal (IVT) injections of an anti-VEGF agent with the last anti-VEGFinjection in the study eye being at least 6 weeks (42 days) before baseline/Day 1.

4. Subject has documentation of anti-VEGF responsiveness

5. Subject must provide written informed consent before any study-related proceduresare performed

6. Clear ocular media and adequate pupil dilation in both eyes to permit good-qualityphotographic imaging

nAMD subject

1. The active CNV is confirmed by FA (evidence of leakage)

2. Residual intraretinal or subretinal fluid based on SD-OCT

3. CST ≥ 300 µm as assessed by SD-OCT

4. Total lesion size < 10 disc areas (25.4 mm2)

5. Absence of geographic atrophy within 200 µm of the fovea

6. If subretinal hemorrhage is present, it must be < 50% of the total CNV lesion and/ornot involve the fovea

7. If fibrosis is present, it must be <50% of the total lesion area

DME subject

1. Diagnosis of diabetes mellitus (Type 1 or Type 2)

2. Subject has clinically significant DME with central involvement (CST≥300 μm by OCT)

3. The decrease in vision in the study eye was determined by the investigator to beprimarily the result of DME

Exclusion Criteria:

1. Previous treatment for nAMD or DME in the study eye other than standard-of-careanti-VEGF IVT injection, e.g., cell therapy, brachytherapy, gene therapy

2. Uncontrolled IOP, defined as an IOP > 25 mmHg

3. Poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) >10% atscreening visit

4. The spherical equivalent for refractive error in the study eye of worse than 8.0diopters of myopia (before cataract or refractive surgery) per the currentprescription

5. Any history of active bacterial, viral, fungal, or parasitic ocular or periocularinfection, or intraocular inflammation in either eye within the 30 days before thescreening Visit

6. History of vitreous hemorrhage within 3 months before screening in the study eye

7. Uncontrolled systemic disease or any other condition or therapy that would make theparticipant unsuitable for the study

8. Participation in any investigational study within 60 days before the screeningvisit, or planned use of an investigational product or device during the study; anyexposure to a prior investigational drug product must be fully washed out (at least 5 half-lives)

9. History of allergy or hypersensitivity to constituents of the study treatmentformulation, topical iodine, ocular antimicrobial solutions, or clinically relevanthypersensitivity to fluorescein