A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD

Inclusion Criteria:

• ≥55 years of age

• Willing and able to provide written informed consent

• Willing and able to comply with the study schedule and study assessments

• Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmicsolution

• BCVA of ≥50 letters in the study eye using Early Treatment Diabetic RetinopathyStudy (ETDRS) chart (i.e., 20/100 Snellen equivalent). Criterion will be confirmedat Baseline

• Refractive error between +3 and -6 diopters spherical equivalent in the study eye

• Sufficiently clear ocular media and adequate pupillary dilation to permit qualityfundus imaging of the study eye, in the opinion of the Investigator. Criterion willbe confirmed at Baseline

• Diagnosed with non-foveal GA secondary to non-neovascular AMD in the study eye, asconfirmed by the reading center

1. Well-delineated cumulative GA area between 1.25 and 12.0 mm2

2. If GA is multifocal, at least 1 lesion ≥1.25 mm2

3. GA lesions must be located outside a ≥100 µm radius from the center point ofthe fovea (i.e., this area must have intact retinal pigment epithelium [RPE]and outer retina)

4. GA lesions must be located (partially or wholly) within a 2000 µm radius fromthe center point of the fovea

5. GA lesions must be completely located within FAF imaging field (field 2 to 30-degree image centered on the fovea). GA lesion borders must be >300 µm fromimage edges

6. GA lesions must be >300 µm from the optic disc and/or peripapillary atrophy

7. Area of PRD must be cumulatively between 7.25 and 25.0 mm2

Exclusion Criteria:

1. Presence or history of choroidal neovascularization (CNV). Criterion will beconfirmed at Baseline

2. History of laser therapy in the macular region, regardless of indication

3. History of herpes zoster

4. Ophthalmic disease or condition that requires or is likely to require surgery duringthe study period

5. GA with cumulative area <1.25 mm2

6. Any GA lesion within 100 µm radius from the center point of the fovea

7. Axial length >26 mm

8. Any ocular disease or condition other than non-neovascular AMD that may, in theopinion of the Investigator, interfere with study assessments, patient adherence tothe study schedule, or interpretation of study data (e.g., epiretinal membrane,macular hole, glaucomatous optic neuropathy, etc.)

9. Intraocular surgery (including cataract extraction and crystalline lens replacement)within 3 months before Visit 1a or yttrium aluminum garnet (YAG) surgery within 2months before Visit 1a, or planned either during the study period

10. Use of pegcetacoplan or avacincaptad pegol within 6 months before Visit 1a, orplanned use during the study period

11. Use of any prescription or over-the-counter ophthalmic medication within 1 monthbefore Visit 1a or planned use during the study period

12. Use of rigid contact lenses within 1 month before Visit 1a or planned use during thestudy period Non-study Eye:

13. BCVA of <5 letters using ETDRS chart (i.e., 20/800 Snellen equivalent) Either Eye:

14. History of uveitis

15. GA secondary to any condition other than non-neovascular AMD

16. History of active ocular infection or inflammation within 3 months before Visit 1aor Baseline. Criterion will be confirmed at Baseline

17. Underwent investigational treatment for AMD within 6 months before Visit 1a General Exclusion Criteria:

18. History of therapeutic radiation to the cranium

19. Known allergy or hypersensitivity to the investigational medicinal product (IMP) orany of its excipients

20. History of malignant disease

21. Use of hydroxychloroquine within 1 month before Visit 1a, or planned use during thestudy period

22. Participated or plan to participate in any other IMP study within 1 month beforeVisit 1a or during the study period

23. Use of lutein >10 mg per day or zeaxanthin >2 mg per day within 1 month before Visit 1a, or planned use during the study period

24. Any medical condition (including mental), in the opinion of the Investigator, thatcould interfere with study assessments, patient adherence to the study schedule, orinterpretation of study data

25. Screening laboratory values, in the opinion of the Investigator, that make thepatient unsuitable for study participation

26. Pregnant, nursing, or planning a pregnancy during the study. Criterion will beconfirmed at Baseline

27. Unwilling or unable to use an acceptable method of contraception throughout thestudy if a woman of childbearing potential (WOCBP) or if a sexual partner of a WOCBP