Safety Study of a Single IVT Injection of QPI-1007 in Chronic Optic Nerve Atrophy and Recent Onset NAION Patients

Key Stratum I (Chronic Optic Nerve Atrophy) Inclusion Criteria:

• "Legally blind" in the study eye as the result of an irreversible condition affecting the posterior segment of the eye.
• Clear ocular media and able to undergo adequate pupil dilation.
• Visual acuity and visual field in the non-study eye are better than or equal to the study eye
• At least 21 years old.

Key Stratum I (Chronic Optic Nerve Atrophy) Exclusion Criteria:

• For the study eye only: history of any IVT injection or vitrectomy, vitreous hemorrhage, retinal detachment, or active inflammatory condition (e.g. conjunctivitis).
• For either eye: history of uveitis.

Enrollment is now closed in Stratum I.

Key Stratum II (Acute NAION) Inclusion Criteria:

• Positive diagnosis of NAION with symptom onset within 28 days prior to planned dosing with QPI-1007.
• Visual acuity in the study eye is between 20/40 and light perception.
• Clear ocular media and able to undergo adequate pupil dilation.
• At least 50 years old.

Key Stratum II (Acute NAION) Exclusion Criteria:

• For the study eye only: Macular disease, retinopathy, or other eye disease limiting visual acuity; prior intraocular surgery (other than Lasik) and cataract surgery within 3 months prior to dosing; glaucoma laser surgery within 1 month prior to dosing; pain on or aggravated by eye movement; history of vitreous hemorrhage; history of retinal detachment; any active inflammatory condition (e.g. conjunctivitis); glaucoma or ocular hypertension; or intraocular pressure > 26 mmHg.
• For either eye: History of optic neuritis; or history of uveitis.
• Received any treatment for NAION prior to dosing.
• Any other abnormality which in the opinion of the investigator is suggestive of a disease other than NAION in the study eye only.
• Clinical evidence of temporal arteritis.
• History of collagen vascular disease or other inflammatory disease, or history of multiple sclerosis.

Enrollment in Stratum II is still open.