Pharmacia Corporation (NYSE:PHA) announced today that the company has successfully completed the Mutual Recognition Process in Europe for the use of XALATAN(R) (latanoprost ophthalmic solution) as a first line treatment for lowering elevated intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension. The new indication means the prescription eye drop XALATAN can be used in Europe as initial treatment in place of older prescription eye drops, such as beta-blockers. XALATAN is the only prostaglandin glaucoma medication with first line status in Europe. Regulatory authorities in Sweden recently approved XALATAN for first line use under a separate application. Xalatan is also approved as first line glaucoma therapy in Japan.
The UK Medicines Control Agency is acting as the Reference Member State for XALATAN, where the product was first licensed six years ago for patients with elevated IOP not adequately controlled with other medicines. National approvals for use of XALATAN as first line treatment are expected in all EU member states.
"Gaining mutual recognition for XALATAN first line in Europe is further evidence that XALATAN is emerging as a new standard in glaucoma therapy," said Paul Chaney, Vice President, Global Ophthalmology Business, Pharmacia. "Now doctors in Europe will have the option of prescribing once-daily XALATAN instead of a beta blocker as initial monotherapy treatment. This is good news for the estimated four to five million glaucoma patients in Europe, because once-daily XALATAN has unsurpassed efficacy and can be prescribed for patients with cardiovascular or cardiopulmonary conditions, unlike some older glaucoma medicines."
When introduced in Europe in 1996 as a second-line therapy, XALATAN was the first prostaglandin-based medicine to treat elevated IOP in patients with open-angle glaucoma and ocular hypertension. Over time, XALATAN increasingly became an important therapeutic alternative to older medications, particularly for patients with asthma or heart conditions in whom beta-blocker eye drops are contraindicated and those with an IOP not adequately controlled by other medications.
Pharmacia Corporation manufactures XALATAN(R) (latanoprost ophthalmic solution), the world's number one brand of glaucoma medication (based on market share). XALATAN is available in more than 50 countries, with more than 300 peer-reviewed published papers and 74 million prescriptions written worldwide. In the United States, XALATAN is indicated for the reduction of elevated IOP in patients with open-angle glaucoma and ocular hypertension who are intolerant of other IOP-lowering medications or insufficiently responsive (failed to achieve target IOP determined after multiple measurements over time) to another IOP-lowering medication. The most commonly reported side effects in eyes of patients treated with XALATAN for six months in clinical studies include blurred vision, burning and stinging, eyelid redness, the feeling that something is in the eye, eye itching, darkening of eye color and irritation of the clear front part surface of the eye. XALATAN can slowly darken eye color in the treated eye by increasing the amount of brown color and can darken eyelids and increase the growth of eyelashes; these changes can be permanent.
Physicians or pharmacists who have clinical questions about XALATAN, and consumers who would like additional information on XALATAN, can call Pharmacia Corporation at 1-800-323-4204.
Pharmacia (NYSE:PHA) is a top-tier global pharmaceutical company with a leading agricultural subsidiary. Pharmacia's innovative medicines and other products save lives and enhance health and wellness. Pharmacia's 59,000 people work together with many diverse stakeholders to bring these benefits to people around the world, and to create new health solutions for the future.
