Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration

Inclusion Criteria:

1. Able and willing to provide informed consent (or have a legally authorizedrepresentative who is able and willing to provide informed consent) prior to anystudy assessments and procedures and comply with the study requirements and visits.

2. Male or female with a diagnosis of CNV secondary to nAMD in the study eye, with nAMDdisease activity at Screening Visit 1.

3. At least 50 years old at Screening Visit 1.

4. An Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA letter score of 35 - 78 (approximate Snellen equivalent of 20/200 to 20/32) in the study eye at ScreeningVisit 1.

5. Demonstrated a meaningful anatomic response to anti-VEGF therapy during screening

6. Able to reliably use eye drops per protocol

Exclusion Criteria:

General Exclusion Criteria

1. History of a medical condition giving reasonable suspicion of a condition thatcontraindicates the use of Ixo-vec, compromises the participant's ability to complywith the planned study activities, or that might affect the interpretation of theresults of the study or render the participant at high risk for treatmentcomplications in the opinion of the Investigator. History of severe coronavirusdisease (COVID-19) infection may meet this exclusion criteria if, in the opinion ofthe Investigator, it is likely to lead to any important complications.

2. Received any prior gene therapy.

3. Prior treatment with any non-gene therapy investigational medicinal product (IMP) ormedical device in the study eye within 3 months of Screening Visit 1 or 5 half-livesof the IMP prior to dosing with Ixo-vec, whichever is longer.

4. Female participants who are pregnant or breastfeeding or who intend to becomepregnant or breastfeed in the future.

5. History or evidence of any of the following cardiovascular diseases:

6. Myocardial infarction in the 6-month period prior to Week 1.

7. Uncontrolled hypertension defined as systolic blood pressure > 160 mmHg ordiastolic blood pressure > 100 mmHg during screening.

8. Stroke in the 6-month period prior to Week 1.

9. History of ongoing bleeding disorders. The use of aspirin or other anticoagulants (e.g., Factor Xa inhibitors) is permitted.

10. Use of systemic immunosuppressive drugs within 90 days prior to Screening Visit 1.Short courses of oral corticosteroids are permitted, as well as any inhaled,intra-articular, nasal or dermal steroid use.

11. Evidence of poorly controlled diabetes or glycated hemoglobin (HbA1c) ≥ 8.0% duringscreening

Ocular Exclusion Criteria

1. Any active ocular or periocular infection in the study eye from Screening Visit 1.

2. History or evidence of the following in the study eye:

3. Intraocular or refractive surgery within 5 months prior to Week 1.

4. Any previous penetrating keratoplasty or vitrectomy.

5. Any previous panretinal photocoagulation.

6. Any previous submacular surgery, other surgical intervention (including portdelivery system) or laser treatment for age related macular degeneration.

7. Any history or evidence of retinal detachment (with or without repair) or retinalpigment epithelium rip/tear in the study eye, as determined by the Investigatorduring screening or at Week 1.

8. Uncontrolled ocular hypertension or glaucoma in the study eye from Screening Visit 1to Week 1 or current use of ≥ 2 IOP lowering medications or normal tensionglaucoma/suspect in the study eye or history of any of the following procedures inthe study eye prior to Week 1:

• Incisional glaucoma surgery (i.e., glaucoma drainage implant/shunt ortrabeculectomy)

• Ocular angle-based surgery (i.e., goniotomy or canaloplasty)

• Minimally Invasive Glaucoma Surgery (MIGS) in the study eye.

• Angle-based glaucoma surgery (e.g., Argon or Selective Laser Trabeculoplasty)

5. Any history of intraocular pressure (IOP) elevation related to topical steroidadministration in either eye.

6. Any history of uveitis or inflammation (grade trace or above) except mildanticipated post operative inflammation that resolved in either eye.

7. Any history of treatment with complement inhibitors for geographic atrophy in thestudy eye.

8. Known history of ocular herpes simplex virus, varicella-zoster virus, orcytomegalovirus, including viral uveitis, retinitis, or keratitis in either eye.