Santen Oy Receives Marketing Authorization for TAFLOTAN®, a New Preservative-free Glaucoma Treatment in Denmark and Germany
May 7, 2008
Taflotan® is the first preservative free prostaglandin eye-drop for glaucoma patients.
Finland – On May 7, 2008, Santen Oy announced that it has received the marketing authorization for Taflotan® (generic name: tafluprost) a new preservative-free prostaglandin for reduction of intraocular pressure in open angle glaucoma and ocular hypertension in Denmark and Germany. Marketing authorizations in other countries are expected in near future.
Taflotan® is the first preservative free prostaglandin eye-drop for glaucoma patients. The new treatment is expected to offer benefits for patients who suffer from side effects of glaucoma eye drops with preservatives, especially patients with dry/sensitive eyes.
Currently, the only proven method for the treatment of glaucoma is to lower the intraocular pressure (IOP), which is the most common risk factor for glaucoma. Taflotan® is effective in reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension. Taflotan® lowered IOP 27-31% from baseline in the pivotal EU study. Most frequently reported adverse drug reaction of Taflotan® is hyperaemia (13%). All adverse effects reported are well known for the prostaglandin class.
Prostaglandins are the first line of treatment for glaucoma patients in several European countries. They have proven efficacy in IOP reduction and are generally well tolerated with less systemic side-effects than other treatments. However, all prostaglandins currently on the market contain a preservative, benzalkonium chloride (BAK).
Taflotan® can be used as a monotherapy with patients who would benefit from preservative-free prostaglandin eye drops, who are insufficiently responsive to first line treatment or are intolerant or contra-indicated to first line treatment. It can also be used as additional treatment to beta-blockers.
Glaucoma is one of the most common eye diseases, occurring predominantly in people aged over 60. Glaucoma causes damage to the optic nerve, resulting in visual loss and if untreated it may lead to blindness. Even in developed countries majority of patients remain undiagnosed. Therefore, diagnosis of glaucoma remains an important issue.
There are an estimated 67 million glaucoma patients in the world. It has been estimated that 6.7 million people in the world are blind because of glaucoma.
Contact: Tuomas Huuhtanen Director of Marketing, Europe Santen Oy, Finland Tel. +358 3 284 8443 tuomas.huuhtanen@santen.fi
Santen is a Japanese pharmaceutical company specializing in the development and manufacturing of ophthalmic products. Santen’s products are available all over Europe and we are the leading manufacturer of ophthalmic products in Northern Europe.
