Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration

Key Inclusion Criteria:

• Presence of at least one large druse >125 microns in diameter due to AMD.

• BCVA letter score of 35 to 70 letters (inclusive) (Snellen equivalent 6/12 to 6/60 [20/40 to 20/200])

Key Exclusion Criteria:

• Any implanted electrical device(s) including deep brain stimulator, hearing orvisual implants (i.e., cochlear implant, auditory brainstem implant, retinalprostheses), and/or cardiac defibrillator/pacemaker.

• Implanted metallic device within 20 cm of the Treatment electrode (study eye(s))and/or the grounding electrode (base of the hairline on the back of the neck).

• Uncontrolled diabetes, defined as glycated haemoglobin (HbA1c) >10% (13.3 mmol/L).

• Current tobacco or tobacco-related product use or history within the past 5 years ofheavy smoking (defined as, on average, more than half a pack of cigarettes per day).

• Known severe allergy to fluorescein dye.

• Medical diagnosis of severe dry eye defined as requiring either artificial tearsmore than six (6) times a day or prescription drops (i.e., Restasis, Xiidra, orCequa).

• History of seizure disorders, chronic migraines and/or cluster headaches.

• History and/or evidence of diabetic retinopathy in either eye as assessed by CF,fundus fluorescein angiography (FA), and OCT, to be confirmed by the Central ReadingCentre.

• Other conditions which pre-dispose to chorioretinal atrophy such as inheritedretinal dystrophy (i.e., Stargardt's disease, Best's disease, pattern dystrophy,central areolar choroidal dystrophy, etc.).

• History and/or evidence of exudative AMD in the study eye as assessed by CF, FA (orOCT-A ), and OCT, to be confirmed by Central Reading Centre.

• GA involving the foveal centre, as assessed by the Central Reading Centre using AFand OCT.

• History of intravitreal injections for GA (e.g., Syfovre or Izervay).

• Treatment with photobiomodulation (PBM) therapy or short pulse laser within 12months prior to screening.

• Glaucoma requiring ≥3 medications and/or drops per day, or history oftrabeculectomy.

• History of any kind of intraocular surgery, excluding cataract surgery performed ≥3months from Screening.

• History of yttrium aluminium garnet (YAG) laser posterior capsulotomy <1 month fromScreening.

• Visually significant cataracts and/or visually significant posterior capsularopacification.

• History of amblyopia.