Safety and Efficacy Study of Topical Administration of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy

Main inclusion/exclusion criteria are listed below. Others may apply.

Inclusion criteria

• Male or female, at least 18 years of age.
• Diagnosis of diabetes mellitus
• Patient must be able to self administer study drug.
• Clinically significant diabetic macular edema in at least one eye ("study eye") involving the center of the macula:
• Mild to severe non proliferative diabetic retinopathy (Early Treatment Diabetic Retinopathy Study [ETDRS] grade between 20 and 53).
• BCVA score ≥ 34 letters and < 80 letters in the study eye.
• Women of childbearing potential must have a negative urine pregnancy test at Screening and be using two highly effective methods of contraception throughout the study.
• Male patients with partners of childbearing potential must agree to use at least one highly effective method of contraception throughout the study.

Exclusion criteria

Ocular conditions:

• Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity.
• Proliferative diabetic retinopathy in the study eye.
• History of panretinal scatter photocoagulation(PRP)in the study eye within 4 months prior to screening, and/or anticipated need for PRP in the 3 months following randomization.
• Active optic disc or retinal neovascularization, rubeosis iridis, active or history of choroidal neovascularization in the study eye.
• History of pars plana vitrectomy at any time, intraocular surgery in the study eye within 90 days prior to screening.
• History of use of intravitreal injectable or periocular depots corticosteroids (other than triamcinolone acetonide)within 3 months prior to the screening visit in the study eye.
• Patients who have previously received triamcinolone acetonide in the study eye:

• The intended dose for each triamcinolone acetonide injection was more than 4 mg.
• The most recent dose was less than 3 months prior to the screening visit.
• Any treatment-related adverse event that was seen, and in the opinion of the investigator, has the potential to worsen or reoccur with study treatment.
• Patients who have previously received anti-VEGF therapy within 3 months prior to the screening visit in the study eye.
• Uncontrolled glaucoma or glaucoma treated by 2 or more medications.
• Aphakia or intraocular lens placement in the anterior chamber of the study eye.
• Any active ocular infection; any history of recurrent or chronic infection or inflammation in the study eye.
• History of herpetic infection in either eye.
• History of corneal pathology/surgery
• Contact lens use at any time during the study.

Systemic conditions:

• Uncontrolled systemic disease.
• Poorly controlled diabetes mellitus.
• Impaired renal function
• Poorly controlled arterial hypertension