A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa

Inclusion Criteria:

1. Males or females ≥ 8 years of age

2. Clinical diagnosis of RP with confirmed genetic diagnosis of autosomal dominant RHOmutation or any other mutation associated with RP.

3. BCVA ≤ 75 letters and ≥25 letters as measured by an ETDRS chart.

4. Visual field of >5° in any meridian as measured by a III4e isopter or equivalent.

5. Able to perform a Luminance LDNA at certain light intensity at the Screening visit.

6. Presence of photoreceptors as determined by SD-OCT

Exclusion Criteria:

1. Subject lacks evidence of outer nuclear layer

2. Previous treatment with a gene-therapy or cell therapy product or treatment with anyinvestigational drug or ocular device within one year.

3. History of corticosteroid related IOP spikes or uncontrolled glaucoma.

4. Absence of large regions of sensitivity in the pericentral and peripheral retinalregions

5. Cataract surgery within 3 months. YAG capsulotomy within 1 month. Any otherintraocular surgery within 6 months.

6. Active ocular/intraocular infection, any history of rhegmatogenous retinaldetachment or Current retinal detachment or retinal implant.

7. Breast-feeding, pregnancy, sperm donation or inability to practice strictcontraception