Sucampo voluntarily suspends tacrolimus eye drops program

July 6, 2005

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.

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.