Roche commences phase III clinical trials for lampalizumab

GA is an advanced form of age-related macular degeneration (AMD), a progressive condition that may induce blindness.

The company has initiated the study to assess the safety and efficacy of lampalizumab, as well as its efficiency in restricting the progression of GA.

In addition, the study will determine, whether the people with a specific genetic biomarker, a mutation in complement factor I, could be benefited from lampalizumab treatment.

The phase III trials, known as Chroma (GX29176) and Spectri (GX29185), are double-masked, randomized studies that will compare 10mg dose of lampalizumab administered every four or six weeks by intravitreal injection to sham injections.

Around 936 patients will be enrolled in each study, which will be recruited from around 300 physician-investigator sites in 24 countries.

Roche global product development head and chief medical officer Sandra Horning said the Lampalizumab has the potential to represent a significant breakthrough for this disease and could provide real hope for GA patients.

"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," Horning added.

The MAHALO phase II primary endpoint demonstrated a 20% reduction in GA lesion progression in patients treated monthly with lampalizumab, as compared with sham at month 18.