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New molecular entity: FDA approved tafluprost 0.0015% (Zioptan, Merck) ophthalmic solution to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Open-angle glaucoma is the most common type of glaucoma, accounting for at least 90% of all cases, and affecting about 3 million Americans. On February 10, 2012, FDA approved tafluprost 0.0015% (Zioptan, Merck) ophthalmic solution to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Tafluprost (acid) is a prostaglandin analog, which is believed to reduce intraocular pressure by increasing uveoscleral outflow of aqueous humor.
Efficacy. Tafluprost 0.0015% ophthalmic solution was evaluated in 5 controlled clinical studies of up to 24 months duration. In study subjects with open-angle glaucoma or ocular hypertension, baseline pressures of 23 mmHg to 26 mmHg, and treated with tafluprost dosed once daily in the evening, reductions in intraocular pressure at 3 and 6 months of 6 mmHg to 8 mmHg and 5 mmHg to 8 mmHg, respectively, were observed. Reduction of the intraocular pressure with tafluprost starts as early as 2 to 4 hours after the first administration, with the maximum effect seen after 12 hours.
Safety. The safety of tafluprost 0.0015% ophthalmic solution was evaluated in 905 patients during the 5 controlled clinical studies. The most common adverse reaction observed in patients treated with tafluprost was conjunctival hyperemia (redness of the lining of the white part of the eye and the underside of the eyelid [conjunctiva]), which was reported in between 4% and 20% of study subjects. Other ocular adverse reactions reported in at least 2% of subjects during clinical trials included: ocular stinging/irritation (7%), ocular pruritus including allergic conjunctivitis (5%), cataracts (3%), dry eye (3%), ocular pain (3%), eyelash darkening (2%), growth of eyelashes (2%), and blurry vision (2%).
Non-ocular adverse reactions reported included: headache (6%), common cold (4%), cough (3%), and urinary tract infection (2%).
Dosing. The recommended dose is 1 drop of tafluprost 0.0015% ophthalmic solution in the conjunctival sac of the affected eye(s) once daily each evening. The dose of tafluprost should not exceed once daily since it has been shown that more frequent administration of prostaglandin analogs may lessen their intraocular pressure-lowering effect.
Tafluprost 0.0015% ophthalmic may be used concomitantly with other topical ophthalmic drugs to lower intraocular pressure. However, patients should be instructed that each topical drop should be administered at least 5 minutes apart.