A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders

A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus PFS in Subjects With Visual Impairment Due to Retinal Disorders, NORSE SEVEN

The study will compare the safety of ophthalmic bevacizumab in vials versus pre-filled syringes in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.

Inclusion Criteria:

• Active clinical diagnosis and OCT confirmation of one of the following retinal disorders: exudative age-related macular degeneration (AMD), diabetic macular edema (DME), or branch retinal vein occlusion (BRVO) and, in the opinion of the Investigator, requires treatment with an anti-VEGF therapy

Exclusion Criteria:

• Previous use of approved anti-VEGF or Avastin® within 4 weeks preceding randomization
• Previous use of Beovu®
• Macular edema due to something other than exudative AMD, DME or BRVO, in the study eye
• History of inadequate response to previous intravitreal anti-VEGF therapy
• History of any intraocular or periocular corticosteroid injection or implant, in the study eye
• Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization
• Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss during the study period
• Active intraocular inflammation in the study eye
• Current vitreous hemorrhage in the study eye
• Polypoidal choroidal vasculopathy (PCV) in the study eye
• History of idiopathic, infectious or autoimmune-associated uveitis in either eye
• Current ocular or periocular infection, such as conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
• Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
• Premenopausal women not using adequate contraception
• Current treatment for active systemic infection
• Known allergy to any component of the study drug , not amenable to treatment