A Phase 1/2, First-in-Human Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Subretinal Injection of SB-007 in Subjects With Stargardt Disease (STGD1)

Inclusion Criteria:

To be eligible for study participation, subjects must meet the following criteria:

1. Provide written consent. Subjects under legal age will also provide informed assentaccording to guidelines set forth by the same.

2. Are male or female adolescents and adults, aged as follows:

3. In Part A, subjects will be ≥18 to ≤65* years (inclusive)

4. In Part B, subject age is planned as ≥12 to ≤65* years (inclusive) *Subjectsaged >65 years may be eligible in Parts A and B, following discussion with, andapproval by, the Medical Monitor.

5. Are able to understand and comply with the study procedures.

6. Have a diagnosis of STGD1 caused by bi-allelic pathogenic, or likely pathogenic,variants in the ABCA4 gene confirmed genotypically by an accredited genetic testinglaboratory

7. Clinical evidence consistent with Stargardt Disease type 1.

8. For women of child-bearing potential (WOCBP), have a negative pregnancy test atScreening and, if due to receive active treatment, at Day 0.

9. For both WOCBP and male subjects (or their female partners who are of child-bearingpotential), agree to either strict abstinence or, if sexually active, use anacceptable contraception measure for 3 months from Day 0

10. Must have clear ocular media and adequate pupillary dilation in the study eye,including no allergy to dilating eyedrops, to permit good quality retinal imaging.

11. Fulfil visual acuity criteria based on ETDRS letter chart

12. Fulfil baseline lesion size measurement, as measured by the Reading Center

13. Evidence of disease progression as determined by the Medical Monitor followingconsultation with the Investigator.

Exclusion Criteria:

Subjects must be excluded from participating in the study if they:

1. Have had any intraocular surgery (including cataract surgery) or thermal laserwithin 90 days of the Screening Visit or planned intraocular surgery (includingcataract surgery) or thermal laser during the period of the study, in the study eye.

2. Have had any major surgical procedure within 30 days of the Screening Visit orplanned or anticipated major surgery during the period of the study.

3. Have two pathogenic or likely pathogenic variants in IRD genes (other than ABCA4) ora single pathogenic or likely pathogenic variant in autosomal dominant or X-linkedIRD genes.

4. Have a history of amblyopia in the study eye.

5. Are unwilling to stop taking the following products at Screening and throughout thestudy:

6. Supplements containing vitamin A or beta-carotene, liver-based products.

7. Prescription oral retinoids. Topical products containing vitamin A or retinoidsare not exclusionary.

8. Have any ophthalmic history of gene therapy, stem cell therapy, surgicalimplantation of prosthetic retinal chips, or intravitreal or sub-retinal orsupra-choroidal injections.

9. Have received any investigational therapy within 90 days of the Screening Visit or 5half-lives, whichever is longer.

10. Have known serious allergies to the fluorescein dye that might be used to measureIOP, ocular dilating drops, topical ocular anesthetic, steroid medication, orcomponents of the SB-007 formulation.

11. Have any significant ocular or non-ocular disease/disorder which, in the opinion ofthe Investigator and with concurrence of the Medical Monitor, may either put thesubject at risk because of participation in the study, may influence the results ofthe study, or affect the subject's ability to participate in the study.

12. Are an immediate family member (e.g., child, sibling) of the Sponsor or study sitepersonnel.