Efficacy & Safety of RPh201 Treatment in Patients With Previous Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

This study is designed as a double-masked, randomized, placebo-controlled, pivotal clinical
study to evaluate the efficacy and safety of SC administration of RPh201 in participants with
previous NAION.

Following a screening phase of 1-8 weeks, participants will attend a baseline visit in which
they will undergo testing and visual function assessments. Participants then will be
randomized to receive RPh201 or control.

After randomization, participants will begin a 26-week schedule consisting of twice-weekly
treatment. Participants will return to the clinic for visits at Week 1, Week 4, Week 12 and
Week 26 and Week 52

Safety and efficacy parameters will be recorded throughout the duration of the study.

Inclusion Criteria:

- The participant must be 50 years of age or older at the time of the NAION episode in
the study eye.

- The participant has a definitive clinical diagnosis of NAION in the study eye that
developed at least 12 months and no more than five years before enrollment.

- The participant's study eye must have stable visual acuity.

- Using the study eye, the participant must read at least 20 and at most 60 EVA letters
(i.e., Snellen equivalent of 20/400 to 20/63) with best-corrected vision.

- The participant's study eye must have a HVF 24-2 Swedish Interactive Testing Algorithm
(SITA) Standard visual field using spot size III with mean deviation -5 dB or worse
and with a visual field defect compatible with NAION in the study eye.

Exclusion Criteria:

- The participant has had treatment with drugs that have potential neuroprotective or
toxic effects on the optic nerve or retina (e.g., ethambutol, amiodarone, linezolid,
hydroxychloroquine, fingolimod) within 6 months prior to enrollment.

- The participant has been receiving or has received within three months prior to
enrollment, corticosteroids (except steroid inhalers or intermittent injections into a
joint or back), immunosuppressive drugs, cytotoxic agents, radiation therapy or
chemotherapy.

- The participant has a known allergy to cottonseed oil.

- The participant has presence of other optic neuropathies (e.g., optic neuritis or
glaucoma) in either or both eyes.

- The participant has systemic inflammatory or infectious disease associated with optic
neuropathy or ocular disease.

- The participant has a history of uveitis in the study eye within the last 10 years.

- The participant's study eye has an ocular condition that appears consistent with a
reduction in visual acuity to <20/25, diabetic retinopathy beyond mild
non-proliferative diabetic retinopathy not involving the macula, or vision-threatening
macula disease.

- The participant has a visual field defect with homonymous non-altitudinal features or
a defect that respects the vertical meridian.