Geographic Atrophy Treatment Evaluation

The Safety and Efficacy of AL-8309B Ophthalmic Solution for the Treatment of Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

The purpose of this study was to evaluate the safety and efficacy of AL-8309B Ophthalmic Solution versus Vehicle administered as a topical ocular drop for the treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Inclusion Criteria:

• Willing to give written informed consent, make required study visits, and follow instructions.
• Able to administer eye drops or have a caretaker to administer the eye drops.
• Study eye: Atrophy secondary to age-related macular degeneration, best corrected visual acuity (BCVA) of 35 letters (20/200 Snellen equivalent) or better, clear ocular media, and adequate pupillary dilation.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Pregnant, nursing, or not using adequate contraception.
• Ocular disease in the study eye, other than non-exudative AMD.
• History of cataract surgery in either eye within the past 3 months of screening.
• History or evidence of serious ocular trauma or intraocular surgery in either eye within the past 6 months of screening.
• Any medical condition that would make participation in the trial or adherence to the study schedule difficult or unlikely.
• Participation in an investigational drug or device study within 30 days of screening.
• Other protocol-defined exclusion criteria may apply.