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

Inclusion Criteria:

1. Males or females ≥ 3 years of age

2. Confirmed genetic diagnosis of autosomal dominant RHO mutation with clinicaldiagnosis of RP

3. Clinical Diagnosis of Syndromic or Non-Syndromic RP with/without confirmed geneticdiagnosis of any other RP associated mutation (except AD-NR2E3)

4. BCVA ≤ 80 letters and ≥25 letters as measured by an ETDRS chart

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

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

7. 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 any corticosteroid contraindication, corticosteroid related IOP spikes oruncontrolled glaucoma.

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

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

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