News-medical.net -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that new Phase III data showed that patients with open-angle glaucoma or ocular hypertension, who were dosed once-daily with tafluprost, Merck’s investigational, preservative-free prostaglandin analogue ophthalmic solution, experienced a reduction in intraocular pressure (IOP) comparable to patients taking twice-daily preservative-free timolol maleate, a beta-adrenergic antagonist. These findings were presented for the first time at the Association for Research in Vision and Ophthalmology (ARVO) 2011 Annual Meeting, held in Fort Lauderdale, FL.
“These results provide important insight into the efficacy and tolerability profile of this investigational medicine,” said Tony Ho, section head of neurology and ophthalmology, Merck. “Merck recognizes the importance in developing new ophthalmic therapies. Tafluprost, if approved, will provide an additional treatment option for patients with open-angle glaucoma or ocular hypertension.”
The New Drug Application (NDA) for tafluprost is under review by the U.S. Food & Drug Administration (FDA) for the proposed use in the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension. On April 15, 2009, Merck and Santen Pharmaceutical Co., Ltd. entered into a worldwide licensing agreement for tafluprost. Merck has exclusive commercial rights to tafluprost in Western Europe (excluding Germany), North America, South America, Africa, the Middle East, India and Australia. Santen retains commercial rights to tafluprost in Germany, most countries in Eastern Europe, northern Europe and in countries in the Asia Pacific region, including Japan. Merck provides promotion support to Santen in Germany. Santen will have the option to co-promote tafluprost in the U.S., if approved.
