Sucampo Pharmaceuticals, Inc., a leader in functional fatty acid research and development, announced that it has initiated a multi-center, Phase II safety and efficacy study for the treatment of dry eye syndrome, also known as keratoconjunctivitis sicca (KCS) with agent FK-506, tacrolimus, a potent immunosuppressive agent.
The study will randomize approximately160 patients with documented KCS into three treatment groups and be conducted at nine sites throughout the United States.
Sucampo announced in February 2002 that it signed an agreement with Fujisawa Pharmaceutical Co., Ltd (Japan) that granted exclusive rights to develop and commercialize tacrolimus, Fujisawa's flagship compound, for ophthalmic indications in the Unites States and certain other territories.
"Ophthalmic treatment is a core focus for us and we have an enormous amount of research and development expertise in this area," said Sucampo Chair and CEO Ryuji Ueno, M.D., Ph.D., Ph.D. "This study moves us closer to fully developing an effective treatment for a condition that causes considerable discomfort for its sufferers."
Tacrolimus is marketed by Fujisawa in many countries, including the United States, as the immunosuppressive agent Prograf for prevention of organ graft rejection and Protopic for the treatment of atopic dermatitis.
With KCS, the sufferer experiences a decline of the quality or quantity of tears bathing the eye. This situation leads to constant pain from eye irritation, and a sandy or gritty sensation that, if untreated, can lead to scarring or ulceration of the cornea, and, thus in some cases loss of vision. While it can occur at any age, the disorder primarily affects the elderly. It is estimated 15 per cent of the U.S. population suffers from KCS.