Roche is beginning Phase III trials of lampalizumab, the first potential treatment for geographic atrophy, the advanced form of age-related macular degeneration.
The Swiss major announced at the EURETINA congress in London that two identical late-stage studies will look to see how lampalizumab can slow the progression of GA, which affects more than 4.5 million people worldwide. Patients have problems with reading, recognising faces and activities in low illumination.
The move into Phase III, where 936 patients will be enrolled in each study, follows data from a mid-stage trial which showed a 20% reduction in GA lesion progression in patients treated monthly with lampalizumab as compared with sham at 18 months. Additionally, data from a sub-population of GA patients receiving monthly lampalizumab and positive for the complement factor I genetic biomarker, demonstrated a 44% decrease in the rate of disease progression and this biomarker analysis will be further evaluated in the Phase III programme.
Sandra Horning, Roche’s chief medical officer, said lampalizumab “has the potential to represent a significant breakthrough for this disease and could provide real hope”. She added that 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”. The latter, Roche notes, is a rate-limiting enzyme involved in the activation of the “alternative complement pathway”, a component of the immune system.
Roche currently markets Lucentis (ranibizumab) with Novartis for wet AMD, macular oedema following retinal vein occlusion and diabetic macular oedema.
