A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)

Key Inclusion Criteria:

• Genetically confirmed diagnosis of primary photoreceptor (PR) disease

• BCVA at Screening for Phase 1: LogMAR 3.9 to LogMAR 1.0. BCVA at Screening for Phase 2: ETDRS letter score 20 and 60.

• Retinal structure examination in the study eye (SE) demonstrating regions suitablefor cell administration.

Key Exclusion Criteria:

• History of/currently active clinically relevant, ocular inflammation or infection

• Glaucoma or other significant optic neuropathy

• Diabetic macular edema or diabetic retinopathy

• Clinically significant cystoid macular edema

• Spherical equivalent refractive error of greater than 8.00 diopters myopia

• Ocular surgery ≤3 months before Screening

• Monocular vision (ie, no light perception in the fellow eye)

• Presence of clinically significant anti-OpCT-001 HLA antibodies at Screening

• Currently active malignancy, or history of malignancy within 5 years before OpCT-001administration. Exception: Basal cell carcinoma that has been definitively treated.

• Any current infection (bacterial/viral/fungal) that could put the participant atrisk from immunosuppression

• History of any cell therapy, gene therapy, or retinal implant at any time

• Previously received a bone marrow or solid organ transplant