Roche announced that the primary endpoint was not met in the first of two phase III studies evaluating the safety and efficacy of lampalizumab, an investigational medicine for treating geographic atrophy (GA) due to age-related macular degeneration (AMD).
Lampalizumab did not reduce mean change in GA lesion area compared to sham treatment at 1 year (48 weeks). Given the lack of efficacy, further dosing in patients will be interrupted until the results from the second phase III study are evaluated, the company said.
“Geographic atrophy is a progressive and irreversible disease that impairs vision, and there are currently no available treatments,” said Sandra Horning, MD, Roche’s chief medical officer and global head of product development. “While this result is disappointing, we will continue to evaluate results from Spectri to get a clearer understanding of the data as we await the results of our second phase III study, Chroma, anticipated in November.”