Clinical Trials

Inclusion Criteria:

• Male and female participants 50 to 80 years of age

• Confirmed clinical diagnosis of unilateral NAION in the study eye with symptom onset within the past 14 days

• Participant must be eligible for randomization and receive the first dose within 14 days of symptom onset

• BCVA score in the study eye of ≥ 15 letters and ≤ 65 letters as measured by the ETDRS chart

• Relative afferent pupillary defect in the study eye (not required if the fellow eye had previous NAION or other optic nerve or retinal disease that is not an exclusion criterion)

Exclusion Criteria:

• Bilateral or sequential NAION with fellow eye involvement within 6 weeks of study eye involvement

• Clinical evidence of temporal (giant cell) arteritis in either eye, OR C reactive protein (CRP) > 2x the institutional upper limit of normal (ULN), OR abnormal erythrocyte sedimentation rate (ESR) (> age/2 mm/hr for males or > (age+10)/2 mm/hr for females), OR thrombocytosis (platelet count > 450,000 uL), in the absence of a known acute cause (eg, infection, anemia, trauma)

• Intraocular pressure (IOP) > 25 mmHg OR history of glaucoma in the study eye • Intermediate age-related macular degeneration (AMD) with subfoveal drusen, geographic atrophy, or exudative AMD in the study eye

• Uncontrolled diabetes mellitus (HbA1c ≥ 8.0%), any diabetic retinopathy, or previous pan-retinal laser photocoagulation or macular laser photocoagulation

• History or evidence of optic neuritis or intraocular inflammation (chronic or recurrent anterior uveitis, any intermediate uveitis, or any posterior uveitis) in either eye

• History or evidence of infectious, nutritional, hereditary, radiation-induced, neoplastic (tumorrelated), toxic, or mitochondrial neuropathies, or any active ocular infection in either eye

• History of multiple sclerosis, collagen vascular disease, other systemic chronic inflammatory disease, or chronic immunosuppressive disease (such as HIV/AIDS)

• Prior or planned use of systemic corticosteroids within the past 1 month, intranasal drugs for more than 7 cumulative days within the past 1 month, any medication or supplement with presumed neuroprotective effect (eg, systemic memantine, topical brimonidine) within the past 6 weeks, immunomodulatory therapy within the past 3 months, amiodarone within the past 12 months, chemotherapy within 3 years, radiation therapy of the head or neck within 20 years, any medication or supplement with known risk of other optic neuropathy or retinal toxicity (eg, ethambutol, hydroxychloroquine).

• Planned use of phosphodiesterase-5 (PDE-5) inhibitors during the study

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 01/05/2026. Questions regarding updates should be directed to the study team contact.