A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED)

Inclusion Criteria:

- Adults ≥18 years old at the time of Screening Visit

- Diagnosis of FCED OU based on clinical and ophthalmic test findings

- Clinical evidence of corneal edema OU diagnosed with FCED, including one or more of
the following signs: corneal epithelial microcysts, corneal epithelial bullae, stromal
folds, or stromal haze

- Central corneal thickness of 550 μm to 700 μm (inclusive) in at least one eye
diagnosed with FCED, as measured by ultrasonic pachymetry at the time of Screening
Visit and Baseline Visit

- Best-corrected distance visual acuity (BCVA) of 20/25 to 20/320 (inclusive) at the
time of Screening Visit and Baseline Visit OU

- Women of childbearing potential must agree to use birth control as specified in the
protocol from the date they sign the informed consent form (ICF) until after the last
study

- Able to give informed consent and willing to comply with all study visits and
examinations

- Part B only: The presence of central endothelium, as determined by the investigator,
with an area of contiguous endothelial cells within 1 mm of the central cornea as
measured by confocal laser scanning microscopy (CLSM) or specular microscopy at the
time of Screening Visit

Exclusion Criteria:

- Corneal findings of any type (including, but not limited to, stromal haze or stromal
scarring), in either eye, that, based on investigator's assessment, limit the
probability of visual improvement after corneal deturgescence

- Any ocular pathology requiring treatment with topical ophthalmic drops, with the
exception of glaucoma or ocular hypertension

- Use of topical hypertonic saline drops for 3 days prior to Screening and throughout
the duration of the study

- History of corneal disease (other than FCED) or corneal surgery in either eye

- Current use or likely need for the use of contact lens at any time during the study

- History of previous corneal or anterior segment surgery such as LASIK, photorefractive
keratectomy, endothelial keratoplasty, penetrating keratoplasty cataract surgery or
glaucoma surgery.

- Any disease or medical condition that in the opinion of the investigator would prevent
the subject from participating in the study or might confound study results

- Participation in other investigational drug or device clinical trials within 30 days
prior to enrollment, or planning to participate in any other investigational drug or
device clinical trials within 30 days of study completion

- Women who are pregnant or lactating

- Part B only: Participation in Part A of SPIFD-101

Other protocol-defined inclusion/exclusion criteria may apply.