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Lampalizumab trial for geographic atrophy fails to meet endpoint
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A phase 3 study of lampalizumab for geographic atrophy failed to meet its primary endpoint of reducing mean change in lesion area, Roche announced in a press release.
The double-masked, randomized, global Spectri trial, the first of two phase 3 clinical trials, showed lampalizumab did not reduce mean change in geographic atrophy lesion area compared with sham treatment after 48 weeks.
Both trials evaluated the safety and efficacy of a 10-mg dose of lampalizumab administered every 4 or 6 weeks by intravitreal injection.
Further dosing in patients will be suspended until results from the second study are evaluated, due to the lack of efficacy shown in the first trial, the release 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 3 study, Chroma, anticipated in November,” Sandra Horning, MD, Roche’s chief medical officer and global head of product development, said in the release.