tafluprost (Saflutan)

following a full submission:

tafluprost preservative-free eye drops (Saflutan) are accepted for restricted use within NHS Scotland for the reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension - as monotherapy: in patients who would benefit from preservative-free eye-drops, who are insufficiently responsive to first-line therapy, or who are intolerant or contraindicated to first-line therapy - or as adjunctive therapy to beta-blockers.

Tafluprost is restricted to use in patients who cannot tolerate currently available prostaglandin preparations due to proven sensitivity to the preservative benzalkonium chloride.

Preservative-free tafluprost has shown equivalence to a formulation of tafluprost with preservative in lowering intraocular pressure. The adverse event profile was similar for both formulations. The formulation of tafluprost with preservative has shown non-inferiority to a beta-blocker but failed to demonstrate non-inferiority to a prostaglandin comparator in a prespecified primary analysis. Saflutan is the only preservative-free prostaglandin eye drop available