Anti-complement C5 monotherapy ineffective in reducing geographic atrophy lesion size
MIAMI — An anti-complement C5 therapy had no different effect on geographic atrophy lesion size than sham therapy, according to a presentation at Angiogenesis, Exudation, and Degeneration 2016.
“No efficacy was observed,” Parisa Zamiri, MD, PhD, said of the treatment drug LFG316 in her presentation on the drug’s 12-month safety and efficacy results.
The multicenter phase 2 trial included 150 patients with bilateral age-related macular degeneration and a geographic atrophy (GA) lesion in the study eye between 3 mm2 and 16 mm2 in area at baseline.
Patients were randomized 2:1 to receive intravitreal injections of 5 mg per month of the study drug or monthly sham treatment in the study eye. Primary endpoint was mean change in GA lesion area at month 12 as assessed by fundus autofluorescence.
“There was no statistically significant treatment difference observed. No difference whatsoever,” Zamiri said of the study’s two groups.
Ninety-nine patients were in the LFG316 group; 51 patients were in the sham group. There were no major imbalances between the groups with regard to age, gender, body mass index, or years of AMD.
With regard to safety, there were no serious adverse events or non-ocular adverse events related to the study drug, Zamiri said.
“A couple of patients with intraocular inflammation and a few patients with raised IOP were similar to [the rates] we’ve seen previously with intravitreal injections,” Zamiri said. The rate of endophthalmitis was also similar to that associated with intravitreal injections, Zamiri said.
Visual acuity gains were nominal, again with no significant difference between LFG316 and sham, she said.
“LFG316 has an acceptable safety profile ... for further development, but monthly treatment with LFG316 monotherapy was not efficacious, either in GA lesion reduction or in visual acuity [gains],” Zamiri said. – by Kate Sherrer and Kristie Kahl
Disclosure: Zamiri reports she is a consultant for Novartis.