Apellis Pharmaceuticals has resumed dosing in two phase 3 trials of intravitreal APL-2, its geographic atrophy treatment, the company announced.
The DERBY and OAKS trials were paused in October 2018 after cases of noninfectious inflammation were observed in patients treated with a single lot of the APL-2 intravitreal investigational material, according to a press release.
The inflammation resolved in all affected patients, and Apellis believes an impurity in the active pharmaceutical ingredient was introduced during the scale-up of the manufacturing process, the release said. The manufacturing
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