Sucampo voluntarily suspends tacrolimus eye drops program

Sucampo Pharmaceuticals Inc., Bethesda, MD, said it has voluntarily suspended its tacrolimus eye drops development program due to FDA safety concerns about Protopic, a prescription cream for the treatment of atopic dermatitis. Protopic's active ingredient is tacrolimus.

The company said it was developing tacrolimus eye drops for the treatment of dry eye syndrome under a license from Fujisawa Pharmaceutical Co. Ltd. (Japan) and had completed its phase II safety and efficacy research.

Even though the agent is not a topical ointment, Sucampo officials stressed that patient safety comes first. The company said in a prepared statement that it will consult with the FDA to determine if and when the dry eye program should resume.