The investigational drug for geographic atrophy in AMD patients would be treating a majorly unmet need — if it succeeds.
Lampalizumab, an investigational medicine for the treatment of age-related macular degeneration (AMD) geographic atrophy (GA), has failed to reach the primary endpoint of its first phase 3 study.
Produced by pharmaceutical company Roche, lampalizumab did not reach goal standards in the first of 2 planned phase 3 studies evaluating the investigational drug's safety and efficacy. In the study, Spectri, the drug did not reduce mean GA lesion area change when compared to sham treatment at the 48-week mark.
The failure to reach efficacy standards means trial patients will no longer be dosed with the potential treatment until the second Phase III trial results are evaluated. For patients, there are no other options in sight. GA, the progressive and irreversible vision impairment that affects about 5 million people worldwide, currently has no available treatments, Roche chief medical officer and global head of Product Development Sandra Horning, MD, said.
"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," Horning said.