NEW ORLEANS – The 18-month results of the MAHALO study demonstrate a positive treatment effect of a complement inhibitor in AMD-related geographic atrophy, according to a speaker here.
“The MAHALO results suggest the CFI biomarker is both prognostic for geographic atrophy progression and predictive for lampalizumab treatment response,” Carl D. Regillo, MD, FACS, said at Retina Subspecialty Day preceding the American Academy of Ophthalmology meeting.
Carl D. Regillo
MAHALO is a phase 2 study that enrolled 129 patients with bilateral geographic atrophy secondary to age-related macular degeneration in the absence of choroidal neovascularization. Patients were randomized 1:2:1:2 in four arms: sham monthly injections, 10 mg lampalizumab monthly, sham injections given every other month and 10 mg lampalizumab given every other month. The primary endpoint was mean change in geographic atrophy from baseline to month 18 assessed by fundus autofluorescence.
“We also evaluated the relationship between specific genetic polymorphisms associated with geographic atrophy disease characteristics and response to lampalizumab,” Regillo said. Of those evaluated – complement factor H (CFH), C3, C2/CFB and CFI, 57% of samples collected were positive for the CFI biomarker.
At the 18-month endpoint, the primary outcome for all patients receiving lampalizumab was a 20.4% reduction in the rate of geographic atrophy growth; in addition, there was a 44% reduction in rate of growth in patients with CFI complement.
Disclosure: Regillo receives research support from Genentech.