AVACINCAPTAD INJ,SOLN

Clinical Criteria Summary

Geographic atrophy that is secondary to a condition other than age-related macular degeneration (AMD)
Ocular or periocular infections
Active intraocular inflammation

Monitor for signs of neovascular AMD due to increased rates associated with use
If anti-VEGF therapy is required, administer separately from avacincaptad administration

• Indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
• Patients must be aged ≥ 50 years with best-corrected visual acuity (BCVA) 20/25 to 20/320.
• Requires a diagnosis of GA secondary to AMD that is nonfoveal centered, and in part within 1500µm from the foveal center.
• Total GA lesion area must be ≥ 2.5 and ≤ 17.5 mm2 (1 to 7 disc areas); if multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA).

• Recommended dose is 2 mg (0.1 mL of 20 mg/mL solution) administered by intravitreal injection to each affected eye.
• Dosing frequency is once monthly (approximately 28 ± 7 days).
• Treatment duration is limited to up to 12 months due to submitted data limitations.

• Patients should be monitored for signs of neovascular AMD (wet AMD) or choroidal neovascularization (CNV)/macular neovascularization (MNV).
• Perfusion of the optic nerve head must be monitored following injection and managed as needed.
• Transient increases in intraocular pressure (IOP) may occur post-injection and should be managed as needed.

• In the absence of contraindications, use should be restricted to the treatment of GA secondary to AMD.
• Patients with evidence of CNV or MNV in either eye were excluded from clinical trials, indicating this population is not established for use.