Pharmacia Corporation announced that the U.S. Food and Drug Administration (FDA) has approved the once-daily prescription eye drop Xalatan (latanoprost ophthalmic solution) as an initial treatment for elevated eye pressure associated with open-angle glaucoma or ocular hypertension. Xalatan is the first and only prostaglandin with a first-line indication for the treatment of elevated eye pressure (intraocular pressure or IOP) in all three major markets: the United States, Europe and Japan.
"The first-line indication supports the use of Xalatan earlier in the treatment process," said Robert Fechtner, Professor of Ophthalmology and Director of the Glaucoma Division, UMDNJ-New Jersey Medical School. "Effective first-line treatment becomes even more important in light of recent studies that have further emphasized the importance of early treatment. Elevated IOP represents a major risk factor for vision loss with glaucoma; the higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss."
Xalatan was introduced in the United States in 1996 as the first prostaglandin-based IOP-lowering medication. The FDA initially approved the medication for second-line use. Second-line usage meant Xalatan could be prescribed to reduce elevated IOP in patients with open-angle glaucoma and ocular hypertension who were intolerant of other IOP-lowering medications or who did not have a sufficient reduction in IOP in multiple measurements using another IOP-lowering medication. The first-line indication is supported by five-year Xalatan safety data submitted to the FDA.
"The first-line indication means that eye doctors will have additional reason to prescribe Xalatan as initial treatment for patients with elevated eye pressure," said Goran Ando, Executive Vice President and President, R & D, Pharmacia Corporation. "Studies show that Xalatan provides unsurpassed IOP reduction and has a well-established safety and tolerability profile. With more than 400 peer-review published papers, 100 million prescriptions worldwide and a first-line indication in more than 80 countries, Xalatan is truly emerging as a standard in the management of elevated IOP."
Scott Christensen, President and Chief Executive Officer of The Glaucoma Foundation, said of the first-line indication for Xalatan: "It is important that doctors and their patients have a number of effective options for treating elevated eye pressure. The FDA approval of Xalatan for initial use in lowering eye pressure in patients with ocular hypertension or open-angle glaucoma provides an effective and well-tolerated treatment option."
Glaucoma affects approximately three million people in the United States and 67 million people worldwide. An estimated three to six million people in the United States have elevated eye pressure. Open-angle glaucoma is a condition in which there is too much pressure in the eye. Too much pressure in the eye can gradually damage the optic nerve, causing the loss of vision, and potential blindness.
Since its introduction, Xalatan has become the leading IOP-lowering agent in the world based on value share and the number-one prescribed IOP lowering agent in the United States.
Administered once daily, Xalatan is believed to lower IOP by increasing the rate at which fluid flows out of the eye. 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, eye 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 increase the amount of brown eye color, can darken eyelids and eyelashes, and increase the growth of eyelashes in the treated eye. Color changes can increase as long as Xalatan is administered; eye color changes are likely to be permanent.