Roche initiates phase III trials for lampalizumab, first potential treatment for geographic atrophy (GA)

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that phase III clinical studies have been initiated for lampalizumab, an investigational drug for geographic atrophy (GA), the advanced form of age-related macular degeneration (AMD), a progressive condition which can result in blindness. The phase III study program will evaluate the safety and efficacy of lampalizumab and its potential to slow the progression of GA. The studies will also further explore if people with a specific genetic biomarker, a mutation in complement factor I, may benefit more from lampalizumab treatment. The trial design was released at the 14th EURETINA Congress 2014 in London.

The MAHALO phase II primary endpoint showed a 20 percent reduction in GA lesion progression in patients treated monthly with lampalizumab as compared with sham at month 18.(1) Additionally, data from a sub-population of GA patients receiving monthly lampalizumab and positive for the complement factor I (CFI) biomarker, demonstrated a 44 percent decrease in the rate of disease progression at 18 months.(1) This exploratory biomarker analysis will be further evaluated in the phase III program.

“Lampalizumab has the potential to represent a significant breakthrough for this disease and could provide real hope for GA patients,” said Sandra Horning, M.D., Head of Global Product Development and Chief Medical Officer at Roche. “It is the first complement targeted therapy for GA to enter phase III, and the only ophthalmic drug in clinical development that specifically targets complement factor D.”