A Phase 2 Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Elamipretide in Subjects With Age-related Macular Degeneration With Geographic Atrophy

Inclusion Criteria:

- 1. Adults ≥ 55 years of age with at least 1 eye with AMD with GA.

Ocular conditions-study eye

2. GA in the study eye at the Screening Visit may be multi-focal, but the cumulative GA
lesion and size must:

1. be ≥ 0.05 mm2 and ≤ 10.16 mm2 and

2. reside completely within the FAF 30 or 35 degree image.

3. No evidence of CNV by history, OCT or FA in the study eye. 4. BCVA by Early
Treatment Diabetic Retinopathy Study (ETDRS) score of ≥ 55 letters (Snellen equivalent
≥ 20/70) in the study eye at the Screening Visit and Baseline Visit.

5. LL BCVA by ETDRS score of ≥ 10 letters in the study eye at the Screening Visit and
Baseline Visit.

6. LL VA deficit (defined as difference the between BCVA and LL BCVA) of > 5 letters
in the study eye at Screening and Baseline Visits.

7. The fellow eye may have any of the following: no AMD, AMD without GA (i.e.,
high-risk drusen), AMD with GA, CNV AMD, or central GA. Ongoing treatment with
anti-angiogenic therapies in the fellow eye is allowable.

8. Sufficiently clear ocular media, adequate pupillary dilation, fixation to permit
quality fundus imaging, and ability to cooperate sufficiently for adequate ophthalmic
visual function testing and anatomic assessment in the study eye.

Systemic and general criteria 9. Able to administer IMP or have an appropriate
designee who can administer the IMP (i.e., a capable family member or a caregiver).

10. Able to provide informed consent and willing to comply with all study visits,
examinations, IMP administrations, and conditions of the study protocol.

11. Women of childbearing potential who are not pregnant or nursing and have a
negative serum pregnancy test at screening.

12. If of childbearing potential or in a relationship with a partner of childbearing
potential, are able to abstain from sex or use acceptable contraception during the
study and for 1 month after last dose.

Exclusion Criteria:

Ocular conditions-study eye

1. The absence of observable hyper-FAF at the margins of the GA in the study eye.

2. Atrophic retinal disease of causality other than AMD including myopia-related
maculopathy and monogenetic macular dystrophies including pattern dystrophy and
adult-onset Stargardt disease in the study eye.

3. Presence or diagnosis of exudative AMD or CNV in the study eye.

4. Presence of retinal vein occlusion in the study eye.

5. Presence of diabetic retinopathy (a history of diabetes mellitus without
retinopathy is not a criterion for exclusion) in either eye.

6. Presence of vitreous hemorrhage in the study eye.

7. History of retinal detachment in the study eye.

8. History of macular hole (stages 2 to 4) in the study eye.

9. Presence of an epiretinal membrane that causes distortion of the retinal contour
in the study eye.

10. Presence of vitreomacular traction in the study eye.

11. At the Screening Visit, advanced glaucoma resulting in a cup to disc ratio of >
0.8 in the study eye.

12. History of glaucoma filtration surgery or uncontrolled glaucoma defined as IOP >
22 mmHg at baseline despite anti-glaucoma treatment with or without topical
anti-hypertensive eye drops in the study eye OR currently using > 2 medications
(note: combination medications count as 2 medications).

13. Presence of visually significant cataract OR presence of significant posterior
capsular opacity in the setting of pseudophakia. Significant cataract is defined
as > +2 nuclear sclerosis based upon the scale below or any Posterior Subcapsular
Cataract in the study eye. The Sponsor, or its designee, will supply the trial
sites with a copy of the standard photographs.

14. Presence of significant keratopathy or any other media or corneal opacity that
would cause scattering of light or alter visual function, especially in LL
conditions in the study eye.

15. Ocular incisional or laser surgery (including cataract surgery) in the study eye
within 90 days before Day 1.

16. Yag laser capsulotomy in the study eye within 30 days before Day 1.

17. Aphakia in the study eye.

18. History of vitrectomy surgery, submacular surgery, or any vitreoretinal surgery
in the study eye.

19. Prior treatment with Visudyne® (verteporfin) ocular photodynamic therapy,
external-beam radiation therapy (for intraocular conditions), or transpupillary
thermotherapy in the study eye.

20. History of subthreshold laser treatment or other forms of photobiomodulation for
AMD in the study eye.

21. Intravitreal drug delivery in the past 60 days or 5-half-lives of the injected
drug whichever is longer (e.g., intravitreal corticosteroid injection, anti
angiogenic drugs, or device implantation) in the study eye.

22. Current use of medications known to be toxic to the lens, retina, or optic nerve
(e.g., deferoxamine, chloroquine/hydroxychloroquine [Plaquenil®], tamoxifen,
phenothiazines, ethambutol, digoxin, and aminoglycosides) from the Screening
Visit through the completion of the trial.

Ocular conditions--either eye

23. History of herpetic infection in either eye.

24. Concurrent disease in either the study eye or fellow control eye that could
require medical or surgical intervention during the study period.

25. Active uveitis and/or vitritis (grade trace or above) in either eye.

26. History of idiopathic or autoimmune-associated uveitis in either eye.

27. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in
either eye.

Systemic conditions

28. Known to be immunocompromised or receiving systemic immunosuppression for ≥ 4
consecutive weeks prior to screening.

29. Any disease or medical condition that in the opinion of the Investigator would
prevent the subject from successfully participating in the study or might
confound study results.

General

30. Participation in other investigational drug or device clinical studies within 30
days of enrollment and/or planning to participate in any other investigational
drug or device clinical studies within 30 days of study completion.

31. History of allergy to fluorescein that is not amenable to treatment.

32. Creatinine clearance of ≤ 30 mL/min at the Screening Visit and Baseline Visit
(using Modification of Diet in Renal Disease Study formula)

33. Inability to comply with study or follow-up procedures.

34. Inability to obtain color fundus photograph, FAF, and FA of sufficient quality to
be analyzed and interpreted.

35. History of allergic reaction to the investigational drug or any of its
components.

36. Prior treatment with Elamipretide.