A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration

Inclusion Criteria:

General Inclusion Criteria

• Participant must be willing to take tacrolimus and willing to discontinue anymedications that have a known strong interaction with tacrolimus.

• Participant is able and willing to undertake all scheduled visits and assessments upto the week 52 visit.

• Participant who is taking an antidepressant must be on a stable and effective dosageand must be willing to take it reliably for as long as it is required.

• Participant must be willing and medically suitable to undergo monitored anesthesiacare during the vitrectomy and subretinal injection.

• Participant agrees to conform to local and institutional policies regarding activeCOVID-19 infections.

• Participant agrees not to participate in another interventional study until the 52-week visit has been completed.

• Female participant is not pregnant or at least 1 of the following conditions apply:

• Not a woman of childbearing potential (WOCBP)

• WOCBP who agrees to follow the contraceptive guidance from the time of informedconsent through at least 52 weeks after investigational product (IP)administration.

• Female participant must agree not to breastfeed starting at screening and throughoutthe study period and for 52 weeks after IP administration.

• Female participant must not donate ova starting at first dose of IP and throughoutthe study period and for 52 weeks after IP administration.

• Male participant with female partner(s) of childbearing potential (includingbreastfeeding partner) must agree to use contraception throughout the treatmentperiod and for 52 weeks after IP administration.

• Male participant must not donate sperm during the treatment period and for 52 weeksafter IP administration.

• Male participant with pregnant partner(s) must agree to remain abstinent or use acondom for the duration of the pregnancy throughout the study period and for 52weeks after IP administration.

Ocular Inclusion Criteria: Study Eye (Both Groups 1 and 2)

• Participant has bilateral AMD and geographic atrophy (GA) secondary to Age-RelatedMacular Degeneration (AMD) in the study eye. GA is defined as sharply demarcatedareas of loss of the retinal pigment epithelial/epithelium (RPE). While havingbilateral GA remains the preferred enrollment criterion, it is not a requirement andGA only in the study eye is admissible, as long as both eyes exhibit AMD.

• Participant has no known history of choroidal neovascularization (CNV) (wet AMD) ineither eye prior to enrollment in the trial and no evidence of prior or active CNVwith optical coherence tomographyangiography (OCT-A) or indocyanine greenangiography (ICG-A), as assessed by the reading center.

• Participant has absence of exudation as assessed by fluorescein angiography (FA) andspectral domain-optical coherence tomography (SD-OCT).

• Participant has sufficiently clear ocular media, adequate pupillary dilation, andfixation to permit quality fundus imaging.

• Participant is pseudophakic.

Ocular Inclusion Criteria: Study Eye (Group 1 only)

• For cohort 1, the participant has a BCVA between light perception and /= 20/500) and 37 (

• Participant has the total GA area

Ocular Inclusion Criteria: Study Eye (Group 2 only)

• Participant has BCVA score between 38 (>20/200) and 65 (

• Participant has the total GA area of >/= 2.54 mm^2 and /=1 and

• Participant has a difference in mean mesopic sensitivity

Exclusion Criteria:

General Exclusion Criteria

• Participant has a history of recurrent varicella zoster virus (VZV) infection or aclinical diagnosis of VZV infection within 4 weeks of the baseline visit or positiveanti-VZV immunoglobulin M (IgM). Being positive for immunoglobulin G (IgG),indicative of a past infection (or vaccination), is not an exclusionary criterion.

• Participant has a history of recurrent cytomegalovirus (CMV) infection or a clinicaldiagnosis of CMV infection within 4 weeks of the baseline visit or positive anti-CMVIgM. Being positive for IgG, indicative of a past infection, is not an exclusionarycriterion.

• Participant has a positive tuberculosis (TB) test during the screening period by aninterferon gamma release assay (e.g., QuantiFERON) within the 6 months prior to thescreening. If a participant has tested negative for TB within the 6 months prior tothe screening visit, retesting is not required unless clinically indicated.

• Participant has a history or suspected active infection of toxoplasmosis or presenceof elevated immunoglobulin M (IgM) toxoplasmosis titer within 4 weeks of thebaseline visit.

• Participant has an active infection (ocular or non-ocular) requiring the prolongedor chronic use of antimicrobial or anti-infective agents.

• Participant has a current malignancy or history of malignancy within the past 5years, except non-metastatic basal or squamous cell carcinoma or keratoacanthoma orBowen's disease or carcinoma-in-situ of the cervix that has been successfullytreated.

• Participant has a history of a solid organ or bone marrow transplant.

• Participant has any condition that would prohibit the use of systemicimmunosuppression with tacrolimus.

• Participant is receiving or has received any immunosuppressive therapy (IMT) (otherthan topical, inhaled or low dose systemic corticosteroid use not exceeding 7.5 mgof prednisone daily [or equivalent]) within 6 weeks or 5 plasma half-lives,whichever is longer, prior to the administration of adjunct study medications.

• Participant has a history of myocardial infarction in previous 12 months and whosedisease is either unstable and/or symptomatic (e.g., angina, dyspnea, etc.).

• Participant has electrocardiogram (ECG) results that are clinically significant andcould either jeopardize the safety of the participant, impact the participant'sability to comply with study visit schedule or impact the validity of the studyresults. Participants with a mean Fridericia-corrected QT interval of > 430 ms (formales) and > 450 ms (for females) at screening must be cleared by a cardiologistprior to the baseline visit.

• Participant has a study day diastolic blood pressure > 95 mmHg, at either thescreening or baseline visit. Study day blood pressure is defined as the average ofthe second and third readings at a study visit. If the study day blood pressureexceeds the limits, 1 additional triplicate can be taken.

• Participant has an estimated glomerular filtration rate (eGFR) of

• Participant has an alanine aminotransferase (ALT), aspartate aminotransferase (AST)or gamma- glutamyltransferase (GGT) and total bilirubin (TBL) >/= 2 times the upperlimit of normal (ULN).

• Participant has severe anemia (hemoglobin < 9 g/dL [male] or hemoglobin < 8 g/dL [female]), leucopenia (white blood cell count < 2500/mm^3), thrombocytopenia (platelet count < 80000/mm^3) or polycythemia (hematocrit > 54% [male] or hematocrit > 49% [female]).

• Participant has a hemoglobin A1c > 8.5%.

• Participant has a clinically significant coagulopathy (i.e., activated partialthromboplastin time [aPTT] >/= 1.5 times the ULN and/or prothrombin time adjustedfor the international normalized ratio [PT-INR] >/=2.0).

• Participant has serology results indicative of having syphilis, Lyme disease, humanimmunodeficiency virus infection or active infection with hepatitis A virus (HAV),hepatitis B virus (HBV), hepatitis C virus (HCV), or varicella-zoster virus (VZV).

• Participant has a history of familial adenomatous polyposis or inflammatory boweldisease (i.e., Crohn's disease, ulcerative colitis).

• Participant has a history of allergic reaction to mydriatics or fluorescein.

• Participant has a history of gene therapy or cell transplant therapy, includingASP7316, in a prior clinical study.

• Participant has participated in any studies of an investigational drug or procedure (excluding vitamins and minerals for AMD studies) within 12 weeks prior to thescreening visit, except as noted in below criterion.

• Participant has participated with the study eye in any trial of a now FDA-approvedcomplement inhibitor and/or has received an FDA approved complement inhibitorinjection in the study eye within 24 weeks of the screening visit. After a washoutperiod of 24 or more weeks, participants previously treated with a complementinhibitor will be eligible for participation, but participants will not be allowedto resume receiving any approved or investigational complement inhibitor in thestudy eye until the completion of the 52-week follow up period of the A7317-CL-0003trial. Use of an FDA-approved complement inhibitor in the fellow, non-study eye isallowable.

• Participant is unwilling to discontinue or avoid any CYP3A4 inducers (e.g.,rifampin, rifabutin, phenytoin, carbamazepine, phenobarbital, St John's Wort) orparticipant is unwilling to discontinue or avoid protease inhibitors (e.g.,nelfinavir, telaprevir, boceprevir), direct Factor Xa inhibitors, direct thrombininhibitors, verapamil, diltiazem or erythromycin while taking tacrolimus.

• Participant has a positive urine screen for drugs of abuse (amphetamines,barbiturates, benzodiazepines, opiates, cocaine, phencyclidine and methadone),unless the drug is taken for a documented medical condition and under thesupervision of a physician.

Ocular Exclusion Criteria - Study Eye

• Participant has macular degeneration due to causes other than AMD (e.g., Stargardtdisease, cone rod dystrophy, toxic maculopathies, etc.)

• Participant has developed CNV (wet AMD), also known as exudative AMD in either eye.

• Participant has foveal sparing as determined by the presence of potentially viablephotoreceptors, as evidenced by presence of an intact ellipsoid zone (EZ)

• Participant has a history of vitrectomy or submacular surgery, or any surgicalintervention for AMD. Participants with a history of non-AMD-related surgicalinterventions (other than vitrectomy and submacular surgery) are potentiallyeligible if they meet all other inclusion/exclusion criteria.

• Participant has prior treatment with photodynamic therapy (e.g., Visudyne®),intraocular external-beam radiation therapy or transpupillary thermotherapy.

• Participant has a history of previous laser photocoagulation for choroidalneovascularization (CNV), diabetic macular edema, retinal vein occlusion andproliferative diabetic retinopathy.

• Participant has an abnormality of vitreoretinal interface (e.g., tractionalepiretinal membrane (ERM)), which can interfere with measurement of macularthickness or with the potential for macular structural damage.

• Participant has a history of cystoid macular edema, retinal vascular occlusion,central serous chorioretinopathy, macular hole or retinoschisis in the study eye.

• Participant has peripheral holes or other peripheral retinal lesions that areconsidered of rhegmatogenous potential (that is, with a risk of causing retinaldetachment).

• Participant has active or history of intraocular inflammation such as uveitis,chorioretinitis and optic neuropathy (other than glaucoma).

• Participant has presence of an ocular toxoplasmosis scar.

• Participant has nevus of Ota (oculodermal melanocytosis), a pigmented choroidallesion showing characteristics associated with high risk of malignancy (e.g.,elevated lesion) or a choroidal nevus in the macula.

• Participant has pathologic myopia defined as a spherical equivalent of > 8.00diopters or axial length > 28 mm at the screening visit, or myopic maculardegeneration or posterior staphyloma.

• Participant has glaucoma with uncontrolled intraocular pressure (IOP) (defined asIOP > 30 mmHg despite treatment with anti-glaucoma medication) or is using more than 2 agents to control IOP or a history of glaucoma-filtering surgery.

• Participant has a history of corneal transplantation.

• Participant has monocular vision; no light perception in the fellow eye oranophthalmic in the fellow eye.

• Participant has a contraindication to pupil dilation.

• Participant has any other ocular condition that can interfere with the assessment ofimaging data.