Apellis Pharmaceuticals Inc. said it temporarily paused the dosing of patients in a late-stage development program of its APL-2 eye drug after it observed cases of noninfectious inflammation.
A phase 3 trial is evaluating APL-2 in patients with an eye condition known as geographic atrophy, which can cause blindness among people aged 50 and above.
According to the company, eight patients developed noninfectious inflammation after being treated with a single manufacturing lot of the drug. Four of these were in the phase 3 trial, while the other four were in a phase 2 trial of patients with wet macular degeneration, or wet AMD, which is continuing dosing with a different APL-2 manufacturing lot.
The Crestwood, Ky.-based company said it will study the single lot to determine whether it did indeed cause the inflammation and will resume dosing by the end of 2018 if that is the case.
APL-2 was granted the fast-track designation by the U.S. Food and Drug Administration in July.