US FDA accepts Merck & Co NDA for eye drug Saflutan and Lundbeck's clobazam

US drug giant Merck & Co (NYSE: MRK) says that the Food and Drug Administration has accepted for review its New Drug Application for Saflutan (tafluprost), an investigational preservative-free prostaglandin analogue ophthalmic solution.

Merck submitted an NDA to support the proposed use of Saflutan for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. The drug is believed to help increase the fluid drainage that occurs through the root of the iris in the eye (this fluid is also known as aqueous humor). Saflutan is currently approved in several European countries, including the UK, Spain and Italy. Additional launches in other countries are expected, pending regulatory approvals.

“Merck has been providing new therapies to help treat eye diseases for more than 50 years,” said Joseph Markoff, global director, Scientific Affairs, Ophthalmology, at Merck. “The acceptance of the NDA submission for tafluprost is an important milestone in our effort to bring forward an additional therapeutic option for patients with primary open-angle glaucoma or ocular hypertension."