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FDA Approved Drugs » 2012
Medical Areas: Ophthalmology | Family Medicine
View By:Year | Company | Conditions | Therapeutic Areas | Drug Names
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved February 2012
Treatment Area: elevated intraocular pressure
Zioptan (tafluprost ophthalmic solution) is a fluorinated analog of prostaglandin F2a. It acts on the same receptors in the eye as the natural prostaglandins. It causes an increase in the drainage of aqueous humour out of the eyeball, which decreases the pressure within the eye.
Zioptan was specifically approved for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Zioptan is supplied as a solution for intraocular injection. The recommended initial dose is one drop in the conjunctival sac of the affected eye(s) once daily in the evening.
FDA ApprovalThe FDA approval of Zioptan was based on clinical studies up to 24 months in duration. Subjects with open-angle glaucoma or ocular hypertension and baseline pressure of 23 - 26 mm Hg were treated with Zioptan dosed once daily in the evening. Zioptan demonstrated reductions in intraocular pressure at 3 and 6 months of 6 to 8 mmHg and 5 to 8 mmHg, respectively.
Adverse events associated with the use of Zioptan may include, but are not limited to, the following:
Zioptan (tafluprost ophthalmic solution) is a fluorinated analog of prostaglandin F2a. It is a selective FP prostanoid receptor agonist which is believed to reduce intraocular pressure by increasing uveoscleral outflow. The exact mechanism of action is unknown at this time.
Chabi A, Varma R, Tsai JC, Lupinacci R, Pigeon J, Baranak C, Noble L, Lines C, Ho TW Randomized Clinical Trial of the Efficacy and Safety of Preservative-free Tafluprost and Timolol in Patients With Open-Angle Glaucoma or Ocular Hypertension. American Journal of Ophthalmology 2012 Feb 4
Erb C, Lanzl I, Seidova SF, Kimmich F Preservative-free tafluprost 0.0015% in the treatment of patients with glaucoma and ocular hypertension. Advances in Therapy 2011 Jul;28(7):575-85
Pozarowska D Safety and tolerability of tafluprost in treatment of elevated intraocular pressure in open-angle glaucoma and ocular hypertension. Clinical Ophthalmology 2010 Oct 21;4:1229-36
For additional information regarding Zioptan or elevated intraocular pressure, please visit the Zioptan web page.
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