Please login to the form below

Not currently logged in
Email:
Password:

Roche moves eye drug lampalizumab into phase III

It could be the first treatment for geographic atrophy
Roche - Basel, SwitzerlandRoche has begun phase III trials of lampalizumb, moving it a step closer to becoming the first approved treatment for the eye condition geographic atrophy (GA).

A late stage form of age-related macular degeneration (AMD), GA involves the progressive atrophy of the retinal pigment epithelium, choriocapillaris and photoreceptors, and can result in blindness.

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

“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.”

To date lampalizumab showed a 20% reduction in GA lesion progression in patients treated monthly with the drug compared with placebo after 18 months in the phase II MAHALO phase II trial.

Roche was keen to point out that a sub-population of GA patients receiving monthly lampalizumab, and who tested positive for the complement factor I (CFI) biomarker, demonstrated a 44% decrease in the rate of disease progression.

The pharma company said analysis of the biomarker would be further explored during phase III, when it will look at whether people with the CFI biomarker could benefit more than those without it from lampalizumab treatment.

Roche's phase III study programme will evaluate lampalizumab's safety and efficacy, and its potential to slow the progression of GA, which affects more than 4.5 million people worldwide.

The phase III trials will involve 936 patients in each of the two randomised studies - 188 biomarker-positive patients and 124 biomarker-negative patients each for the placebo, both lampalizumab q4w and q6w arms of the trial.

The primary objective of the studies is to demonstrate a reduction in the rate of GA disease progression. This will be determined by the mean change in the GA lesion area of the chosen study eye from baseline in one year - week 48 - as measured by fundus autofluorescence (FAF), an imaging technique used to provide information about the size and type of GA lesions in the macula

Article by
Kirstie Pickering

16th September 2014

From: Research, Sales

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Hanson Zandi

Hanson Zandi is a Creative and Digital Healthcare Agency. We combine 30 years’ experience with the enthusiasm of a start-up...

Latest intelligence

International Childhood Cancer Day 2019
The number of new cases per year is shocking but the journey and the outlooks have vastly improved. We've pulled together an infographic to show just what we mean with...
Immuno-oncology in 2019: the rapid evolution continues
Immunotherapy is pharma’s biggest growth driver – how will it develop in 2019?...
Mixing up Focus Groups
A nice spread of homogeneous participants in a focus groups are often a go to for reliable research outcomes but there's much to be said for mixing it up and...

Infographics