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References

  1. Bournias TE, Lee D, Gross R, Mattox C. Ocular hypotensive efficacy of bimatoprost when used as a replacement for latanoprost in the treatment of glaucoma and ocular hypertension. J Ocul Pharmacol Ther. 2003;19(3):193-203.
  2. Cantor LB, WuDunn D, Cortes A, Hoop J, Knotts S. Ocular hypotensive efficacy of bimatoprost 0.03% and travoprost 0.004% in patients with glaucoma or ocular hypertension. Surv Ophthalmol. 2004;49(suppl 1):S12-S18.
  3. Cohen JS, Gross RL, Cheetham JK, VanDenburgh AM, Bernstein P, Whitcup SM. Two-year double-masked comparison of bimatoprost with timolol in patients with glaucoma or ocular hypertension. Surv Ophthalmol. 2004;49(suppl 1):S45-S52.
  4. Coleman AL, Lerner F, Bernstein P, Whitcup SM. A 3-month randomized controlled trial of bimatoprost (LUMIGAN) versus combined timolol and dorzolamide (Cosopt) in patients with glaucoma or ocular hypertension. Ophthalmology. 2003;110(12)2362-2368.
  5. DuBiner H, Cooke D, Dirks M, Stewart WC, VanDenburgh AM, Felix C. Efficacy and safety of bimatoprost in patients with elevated intraocular pressure: a 30-day comparison with latanoprost. Surv Ophthalmol. 2001;45(suppl 4):S353-S360.
  6. Gandolfi S, Simmons ST, Sturm R, Chen K, VanDenburgh AM, for the Bimatoprost Study Group 3. Three-month comparison of bimatoprost and latanoprost in patients with glaucoma and ocular hypertension. Adv Ther. 2001;18(3):110-121.
  7. 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.
  8. Lee D, Gross R, Mundorf T, Severin T, for the LUMIGAN Early Experience Study. Efficacy and safety of bimatoprost 0.03% (LUMIGAN) in a large-scale, open-label clinical trial. Poster presented at: the Annual Meeting of the Association for Research in Vision and Ophthalmology; May 5-10, 2002; Fort Lauderdale, Fla.
  9. Mundorf T, Noecker RJ, Earl ML. A multicenter, randomized, investigator-masked comparison of the efficacy of bimatoprost 0.03% versus travoprost 0.004% in African Americans with glaucoma or ocular hypertension. Abstract presented at: the Annual Meeting of the American Glaucoma Society; March 4-7, 2004; Sarasota, Fla.
  10. Noecker RS, Dirks MS, Choplin NT, Bernstein P, Batoosingh AL, Whitcup SM, for the Bimatoprost/Latanoprost Study Group. A six-month randomized clinical trial comparing the intraocular pressure-lowering efficacy of bimatoprost and latanoprost in patients with ocular hypertension or glaucoma. Am J Ophthalmol. 2003;135(1):55-63.
  11. Parrish RK, Palmberg P, Sheu W-P, for the XLT Study Group. A comparison of latanoprost, bimatoprost, and travoprost in patients with elevated intraocular pressure: a 12-week, randomized, masked-evaluator multicenter study. Am J Ophthalmol. 2003;135(5):688-703.
  12. Walters TR, DuBiner HB, Carpenter SP, Khan B, VanDenburgh AM, for the Bimatoprost Circadian IOP Study Group. 24-hour IOP control with once-daily bimatoprost, timolol gel-forming solution, or latanoprost: a 1-month, randomized, comparative clinical trial. Surv Ophthalmol. 2004;49(suppl 1):S26-S35.
  13. Data on file, Allergan, Inc.; R Quinones, MD.
  14. Oddone F, Manni G, Parravano M, Cupo G, Costa G, Bucci MG. Six-months comparison of the efficacy and safety of bimatoprost 0.03% versus the association of timolol 0.5% and latanoprost 0.005%. Poster presented at: the Annual Meeting of the Association for Research in Vision and Ophthalmology; May 8, 2003; Fort Lauderdale, Fla.
  15. Dirks M. Bimatoprost as monotherapy in patients previously treated with timolol/latanoprost dual therapy. Poster presented at: the Annual Meeting of the American Glaucoma Society; February 28-March 3, 2002; San Juan, Puerto Rico.
  16. Data on file, Allergan, Inc.
  17. Gandolfi SA, Cimino L. Effect of bimatoprost on patients with primary open-angle glaucoma or ocular hypertension who are nonresponders to latanoprost. Ophthalmology. 2003;110(3):609-614.
  18. Williams RD. Efficacy of bimatoprost in glaucoma and ocular hypertension unresponsive to latanoprost. Adv Ther. 2002;19(6):275-281.
  19. Noecker RJ, Earl ML, Mundorf T, Peace J, Williams RD. Bimatoprost 0.03% versus travoprost 0.004% in black Americans with glaucoma or ocular hypertension. Adv Ther. 2003;20(2):121-128.
  20. Higginbotham EJ, Batoosingh AL, Bernstein P, Whitcup SM. Efficacy of bimatoprost and timolol in black and nonblack patients with glaucoma or ocular hypertension. Poster presented at: the Annual Meeting of the American Academy of Ophthalmology; October 20-23, 2002; Orlando, Fla.
  21. Walt JG, Lee JT. A cost-effectiveness comparison of bimatoprost versus latanoprost in patients with glaucoma or ocular hypertension. Surv Ophthalmol. 2004;49(suppl 1):S36-S44.
  22. David R, Hirsch J, Walt JG. Economic cost evaluation of an older generic vs a newer antiglaucoma medication. J Man Car Pharm. 2001;7(5):372.
  23. Doyle JJ, Casciano JC, Walt JG. Cost-effectiveness of bimatoprost 0.03% versus a combination product of timolol 0.5% and dorzolamide 2.0% for glaucoma. Value in Health. 2003;6(3):238.
  24. Lee JT, Walt JG. Cost-effectiveness of bimatoprost 0.03% versus travoprost 0.004% for glaucoma. Pharmacotherapy. 2003;23(10):1354.
LUMIGAN Safety Studies References

  1. Data on file, Allergan, Inc.
  2. 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.
  3. Cohen JS, Gross RL, Cheetham JK, VanDenburgh AM, Bernstein P, Whitcup SM. Two-year double-masked comparison of bimatoprost with timolol in patients with glaucoma or ocular hypertension. Surv Ophthalmol. 2004;49(suppl 1):S45-S52.
LUMIGAN Pharmacology References

  1. Sherwood M, Brandt J, for the Bimatoprost Study Groups 1 and 2. Six-month comparison of bimatoprost once-daily and twice-daily with timolol twice-daily in patients with elevated intraocular pressure. Surv Ophthalmol. 2001;45(suppl 4):S361-S368.
  2. Brubaker RF, Schoff EO, Nau CB, Carpenter SP, Chen K, VanDenburgh AM. Effects of AGN 192024, a new ocular hypotensive agent, on aqueous dynamics. Am J Ophthalmol. 2001;131(1):19-24.
  3. Yu M, Ives D, Ramesha CS. Synthesis of prostaglandin E2, ethanolamide from anandamide by cyclooxygenase-2. J Biol Chem. 1997;272(34):21181-21186.
  4. Kozak KR, Rowlinson SW, Marnett LJ. Oxygenation of the endocannabinoid, 2-arachidonylglycerol, to glyceryl prostaglandins by cyclooxygenase-2. J Biol Chem. 2000;275(43):33744-33749.
  5. Woodward DF, Krauss AH-P, Chen J, et al. Pharmacological characterization of a novel antiglaucoma agent, bimatoprost (AGN 192024). J Pharmacol Exp Ther. 2003; 305(2):772-785.
  6. Woodward DF, Krauss AH-P, Chen J, et al. The pharmacology of bimatoprost (LUMIGAN) Surv Ophthalmol. 2001;45(suppl 4):S337-S345.
  7. Woodward DF, Madhu C, Burk RM, et al. AGN 192024 (LUMIGAN): a synthetic prostamide analog that lowers primate intraocular pressure by virtue of its inherent pharmacological activity. Presented at: the Annual Meeting of the Association for Research in Vision and Ophthalmology; May 5-10, 2002; Fort Lauderdale, Fla.
New LUIMGAN Patients References

  1. The 2002 Gallup Study of Eye Health. Survey of glaucoma sufferers. Multi-sponsor Surveys, Inc. October 2002.
  2. Tsai JC, McClure CA, Ramos SE, Schlundt DG, Pichert JW. Compliance barriers in glaucoma: a systematic classification. J Glaucoma. 2003;12(5):393-398.
Know Your Patients References

  1. Cognet-X, Inc. Reports. MHC profiles. June 2004
  2. Glaucoma Research Foundation. Glaucoma patient survey. August 2003.
  3. Data on file, Allergan Inc.; EPIC results.
  4. Bournias TE, Lee D, Gross R, Mattox C. Ocular hypotensive efficacy of bimatoprost when used as a replacement for latanoprost in the treatment of glaucoma and ocular hypertension. J Ocul Pharmacol Ther. 2003;19(3):193-203.
  5. Abelson MB, Mroz M, Rosner SA, Dirks MS, Hirabayashi D. Multicenter, open-label evaluation of hyperemia associated with use of bimatoprost in adults with open-angle glaucoma or ocular hypertension. Adv Ther. 2003;20(1):1-13.
  6. 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.
  7. Noecker RS, Dirks MS, Choplin NT, Bernstein P, Batoosingh AL, Whitcup SM, for the Bimatoprost/Latanoprost Study Group. A six-month randomized clinical trial comparing the intraocular pressure-lowering efficacy of bimatoprost and latanoprost in patients with ocular hypertension or glaucoma. Am J Ophthalmol. 2003;135(1):55-63.
  8. Stewart WC, Kolker AE, Stewart JA, Leech J, Jackson AL. Conjunctival hyperemia in healthy subjects after short-term dosing with latanoprost, bimatoprost, and travoprost. Am J Ophthamol. 2003;135(3):314-320.
  9. Cohen JS, Gross RL, Cheetham JK, VanDenburgh AM, Bernstein P, Whitcup SM. Two-year double-masked comparison of bimatoprost with timolol in patients with glaucoma or ocular hypertension. Surv Ophthalmol. 2004;49(suppl 1):S45-S52.
  10. Parrish RK, Palmberg P, Sheu W-P, for the XLT Study Group. A comparison of latanoprost, bimatoprost, and travoprost in patients with elevated intraocular pressure: a 12-week, randomized, masked-evaluator, multicenter study. Am J Ophthalmol. 2003;135(5):688-703.
Glaucoma Resources References

  1. Kass MA, Heuer DK, Higginbotham EJ, et al. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002;120(6):701-713.
  2. Leske MC, Heijl A, Hussein M, Bengtsson B, Hyman L, Komaroff E, for the Early Manifest Glaucoma Trial Group. Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. Arch Ophthalmol. 2003;121(1):48-56.
  3. Lichter PR, Musch DC, Gillespie BW, et al, and the CIGTS Study Group. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology. 2001;108(11):1943-1953.
  4. The AGIS Investigators. The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration. Am J Ophthalmol. 2000;130(4):429-440.
  5. The Collaborative Normal-Tension Glaucoma Study Group. Comparison of glaucomatous progression between untreated patients with normal-tension glaucoma and patients with therapeutically reduced intraocular pressure. Am J Ophthalmol. 1998;126(4):487-497.
  6. Asrani S, Zeimer R, Wilensky J, Gieser D, Vitale S, Lindenmuth K. Large diurnal fluctuations in intraocular pressure are an independent risk factor in patients with glaucoma. J Glaucoma. 2000;9(2):134-142.
  7. Mao LK, Stewart WC, Shields MB. Correlation between intraocular pressure control and progressive glaucomatous damage in primary open-angle glaucoma. Am J Ophthalmol. 1991;111(1):51-55.
  8. Shirakashi M, Iwata K, Sawaguchi S, Abe H, Nanba K. Intraocular pressure-dependent progression of visual field loss in advanced primary open-angle glaucoma: a 15-year follow-up. Ophthalmologica. 1993;207(1):1-5.
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LUMIGAN (bimatoprost ophthalmic solution) 0.03% is for the treatment of high eye pressure, also called intraocular pressure (IOP), in people with open-angle glaucoma or ocular hypertension.

Important Safety Information
LUMIGAN (bimatoprost ophthalmic solution) 0.03% has been reported to cause darkening (pigmentation) of eye color, eyelid skin and eyelashes, as well as increased growth of eyelashes. Pigmentation changes can increase as long as LUMIGAN is used. After stopping LUMIGAN, darkening of eye color is likely to be permanent while darkening of the eyelid skin and eyelash changes may be reversible. The effects of increased darkening beyond 5 years are not known.

The most common side effects are eye redness,  growth of eyelashes,  and itchy eyes.


 
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