Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

This is a double masked, randomized, sham-controlled efficacy and safety study that will
enroll approximately 800 subjects with recent-onset NAION. Subjects will be randomized into
one of 3 groups in a 1:1:1 ratio, and assigned to receive QPI-1007 and/or a sham procedure.
Subjects will have a two in three (66%) chance of receiving active treatment (no sham
procedure) and a one in three (33%) chance of receiving sham procedure (no active treatment).
Total study time involvement is approximately 12 months.

Key Inclusion Criteria:

- Positive diagnosis of first episode of NAION in the study eye with symptom onset
within 14 days prior to planned study drug administration/sham procedure

- Best corrected visual acuity score in the study eye is better than or equal to 15
letter score, measured using the ETDRS visual acuity protocol at Day 1 prior to study
drug administration/sham procedure.

- Clear ocular media and able to undergo adequate pupil dilation to allow a good fundus
examination

Key Exclusion Criteria:

- Present use or history of any treatment for the current episode of NAION, including
systemic steroids, brimonidine, or traditional Chinese herbal medicine

- Prior episode of NAION in the study eye only

- Present use of drugs known to cause optic nerve or retinal toxicity at Day
1/Randomization, such as: chloroquine or hydroxychloroquine, ethambutol, Vigabatrin.
Subjects who need to be prescribed any of these drugs during the course of the study
will be discontinued from the trial.

- Any medical condition, concomitant therapy, or previous incisional or laser surgery
that, in the opinion of the Investigator, would preclude IVT injection in the study
eye only

- Clinical evidence of temporal arteritis