Geographic Atrophy

The purpose of this trial is to evaluate the safety and efficacy (how effective the drug) of the investigational drug Tinlarebant (or LBS-008) in the treatment of geographic atrophy (GA). This is an experimental study, meaning that the drug has not yet been approved by health authorities, including the Taiwan Food and Drug Administration (TFDA), for the treatment of GA. GA is an advanced stage of dry age-related macular degeneration (AMD). Dry AMD is a disease that affects the central area of ​​the retina (called the macula). In GA, there is extensive tissue damage, creating a central blind spot, which may affect the fovea (the center of vision, where visual acuity is highest), causing difficulty reading or recognizing faces.

Tinlarebant

Tinlarebant

Tablet

5 mg

• The primary efficacy endpoint of this trial was the annual rate of change in atrophic lesion growth, defined as the total area of ​​DDAF growth from baseline to month 24 (i.e., the total area of ​​atrophic lesions at month 24 [mm²] minus the baseline total area of ​​atrophic lesions [mm²], then divided by 2 years). Fundus autofluorescence (FAF) imaging assessment was also performed.

Inclusion Criteria:

Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or both eyes.
Minimum BCVA is required in the study eye

Exclusion Criteria:

The presence of diabetic macular edema or macular disease in either eye.
Diabetic retinopathy more advanced than mild nonproliferative diabetic retinopathy, or any other retinal vascular disease in either eye.
Uncontrolled diagnosed glaucoma in the study eye