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FDA accepts to review Saflutan NDA: Merck

The US Food and Drug Administration (FDA) has accepted Merck's investigational preservative-free prostaglandin analogue ophthalmic solution, Saflutan (tafluprost) new drug application (NDA) for review.

Merck has filed the 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.

Saflutan also helps in increasing the fluid drainage that occurs through the root of the iris in the eye (this fluid is also known as aqueous humor).

Saflutan is the proposed trade name for Tafluprost in the US.

Merck Ophthalmology Scientific Affairs global director Joseph Markoff said 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.