Industry News — Clinical Updates
Lampalizumab for Geographic Atrophy Enters Phase 3 Trials
Roche (Basel, Switzerland) announced that it has initiated 2 Phase 3 studies of lampalizumab (anti-factor D) for the treatment of geographic atrophy (GA). The identical trials, Chroma and Spectri, will evaluate the safety and efficacy of lampalizumab and its potential to slow the progression of GA.
The studies will compare the effectiveness of intravitreal lampalizumab administered every four or six weeks to sham. The primary endpoint will be to demonstrate a reduction in the rate of GA progression while secondary endpoints will assess the impact of lampalizumab treatment on visual function.
In the MAHALO phase 2 study of safety, tolerability, and activity of lampalizumab, there was a 20.4% reduction in mean change from baseline of GA area in the monthly lampalizumab group relative to sham treatment at month 18. No difference was observed with the lampalizumab every other month group relative to sham.
Updated September 18, 2014