Allergan Announces FDA Approval of Lumigan as First-Line Treatment
Allergan Announces FDA Approval of Lumigan as First-Line Treatment for Elevated Eye Pressure in Open-Angle Glaucoma; Indication Expands Approved Uses of Lumigan in the Management of Glaucoma
IRVINE, Calif., June 23, 2006 - Allergan, Inc. today announced that the United States Food and Drug Administration (FDA) has approved Allergan's once-daily prescription eye drop Lumigan (bimatoprost ophthalmic solution) 0.03% as a first-line treatment for elevated intraocular pressure (IOP) associated with open-angle glaucoma or ocular hypertension. The Lumigan first-line indication is in addition to Lumigan's widely established use as a second-line treatment.
"This first-line indication supports the initial use of Lumigan to lower elevated IOP associated with open-angle glaucoma or ocular hypertension," said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development. "We are pleased to offer eye care professionals this effective therapy to treat elevated IOP in their glaucoma patients at any point in the course of the disease."
The FDA approved Lumigan in 2001 as an IOP-lowering medication for second-line use. Since its introduction, Lumigan has been widely prescribed by thousands of eye care professionals to reduce elevated IOP in open-angle glaucoma and ocular hypertension patients 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 FDA's first-line indication for Lumigan helps to validate that the lipid class of medications has become the mainstay of IOP-lowering therapy and that once-a-day lipids are becoming the therapy of choice based on their efficacy, systemic safety and ease of use," said Paul P. Lee, M.D., J.D., Professor of Ophthalmology, Duke University.
Elevated IOP represents a major risk factor for vision loss associated with open-angle glaucoma; the higher the IOP, the greater the likelihood of optic nerve damage, which can lead to vision loss and potential blindness. Lumigan monotherapy delivers effective and sustained lowering of IOP1,2, which is significant because elevated IOP is a leading risk factor for glaucoma and the only risk factor that can currently be treated. Glaucoma currently affects approximately three million people in the United States and 67 million people worldwide3, and is the leading cause of preventable blindness in the United States4. An estimated three to six million people in the United States have elevated IOP5.
About Lumigan
Lumigan (bimatoprost ophthalmic solution) 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Important Lumigan Safety Information
Lumigan has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes, and growth of eyelashes. Pigmentation is expected to increase as long as Lumigan is administered. After discontinuation of Lumigan, pigmentation of the iris is likely to be permanent while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment with Lumigan should be informed of the possibility of increased pigmentation. The effects of increased pigmentation beyond 5 years are not known. In clinical trials, the most frequent events associated with the use of Lumigan, occurring in approximately 15% to 45% of patients, in descending order of incidence, included conjunctival hyperemia, growth of eyelashes, and ocular pruritus.
References:
- Noecker RS, Dirks MS, Choplin NT, et al. A six-month randomized clinical trial comparing the intraocular pressure-lowering efficacy of bimatoprost and latanoprost in patients with ocular hypertension or glaucoma. Amer J Ophthalmol 2003; 135(1):55-63.
- Higginbotham EJ, Schuman JS, Goldberg I, et al., for the Bimatoprost Study Groups 1 and 2. One-year, randomized study comparing bimatoprost and timolol in glaucoma and ocular hypertension. Arch Ophthalmol. 2002; 120(10):1286-1293.
- Robin AL, Covert D. Does adjunctive glaucoma therapy affect adherence to the initial primary therapy? Ophthalmology, 2005; 112(5):863-868.
- The Glaucoma Foundation. "TGF Urges Eye Exams To Detect The Disease Early" January 8, 2006. http://www.glaucomafoundation.org/news_story.php?i=38.
- Kass, Michael A., MD. The Ocular Hypertension Treatment Study. Arch Ophthalmol. 2002; 120:701-713.
Source: Allergan, Inc.
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