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An Update on Bimatoprost (Lumigan®) in Glaucoma Therapy

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An Update on Bimatoprost (Lumigan®) in Glaucoma Therapy DRUG PROFILE An update on bimatoprost (Lumigan®) in glaucoma therapy Robert J Noecker, MD†1 The prostamide bimatoprost (Lumigan®, Allergan Inc.) has been proven highly effective as and Melissa L Earl, MPH2 monotherapy, adjunctive, and replacement therapy for lowering intraocular pressure (IOP) †1Department of and providing good diurnal control of IOP in patients with open-angle glaucoma and Ophthalmology, University of Arizona, Tucson, Arizona ocular hypertension. Target pressure results from large, randomized, multicenter clinical 85711, USA. trials comparing bimatoprost with timolol, latanoprost (Xalatan®, Pharmacia & Upjohn), [email protected] travoprost (Travatan®, Alcon laboratories), fixed combination timolol/dorzolamide 2 Director, Innovative Medical (Cosopt®, Merck Inc.) or latanoprost and timolol gel have been analyzed. In each of the & Epidemiologic Data Solutions (IMEDS), analyses, patients were more likely to achieve low target pressures with bimatoprost than 12625 Frederick St. with the other medications. Patients on bimatoprost therapy achieve low IOP levels that Suite I-5 334 Moreno Valley, are maintained throughout the day and night, and long-term trials have shown that the CA 92553, USA Tel.: +1 909 786 0403 efficacy of bimatoprost is sustained. Bimatoprost has been proven to be safe and well Fax: +1 909 786 0439 tolerated in postmarketing surveillance and, as a once-daily drug, allows for patient [email protected] convenience resulting in better treatment compliance. Bimatoprost may be the most effective medication available for protecting the visual field in patients with glaucoma or ocular hypertension. Overview of glaucoma available. Physicians are now targeting greater The American Academy of Ophthalmology IOP reductions and lower IOP levels for their (AAO) defines glaucoma as “a multifactorial patients than thought necessary in years past. optic neuropathy in which there is a characteris- It has been suggested by the AAO that, for tic acquired loss of retinal ganglion cells and patients with mild damage (optic disc cupping atrophy of the optic nerve” [1]. but no visual field loss), the initial target pres- The disease is characterized by progressive reti- sure should be 20 to 30% lower than baseline, nal ganglion cell (RGC) loss, gradual optic disk while for patients with advanced damage the cupping, and associated visual field deficits. Ele- target pressure should be a reduction of 40% vated intraocular pressure (IOP) is not currently or more from baseline. included in the definition, but it is still listed as Studies have shown that low pressures are an important contributing factor. It is a com- beneficial in preserving the visual field in glau- mon disease occurring worldwide [2], and coma patients, even in patients with IOP in the remains a leading cause of blindness [3]. normal range. In a study by Mao and col- Several other risk factors for the development leagues, pressures less than 17 mmHg protected of glaucoma have been identified including; the optic nerve from damage in patients with advanced age, African ancestry, a family history early primary OAG, while pressures over of glaucoma, severe myopia, and ocular trauma. 21 mmHg resulted in optic disc cupping and/or In many cases, the immediate causes of damage visual field loss [4]. In advanced glaucoma, pres- and death of retinal ganglion cells in glaucoma sures substantially lower than 17 mmHg may be are unknown. Lowering IOP is presently the required to prevent deterioration of the visual Keywords: bimatoprost, glaucoma, only proven treatment modality for halting the field. The Advanced Glaucoma Intervention intraocular pressure, ocular progression of glaucomatous damage in open- Study (AGIS) investigators reported that after hypertension, open-angle angle glaucoma (OAG), and normal tension surgery to reduce IOP in advanced glaucoma, glaucoma glaucoma (NTG). eyes with IOP less than 14 mmHg had less vis- ual field loss than those with IOP higher than Rationale for lowering & stabilizing IOP 17.5 mmHg, suggesting that very low target The paradigm for the management of glau- pressures are beneficial for these patients [5]. coma has evolved considerably in recent years Similarly, reducing IOP to low target levels Future Drugs Ltd as new evidence from clinical trials has become decreases the risk of glaucomatous progression 2004 © Future Drugs Ltd ISSN 1475-0708 http://www.future-drugs.com Therapy (2004) 1(1), 31–41 31 DRUG PROFILE – Noecker & Earl in patients with NTG. A 1998 study by the Col- and expected lifespan, and the presence of other laborative Normal Tension Glaucoma Study risk factors for glaucoma such as family history Group reported that a 30% IOP reduction in and race [14,15]. patients with NTG had a significantly favorable effect on visual field stability [6]. Pharmacological approaches to IOP lowering Reducing IOP also decreases the risk of the The medications available for reducing IOP in development of glaucoma in patients with ocular glaucoma patients include topical β-adrenergic hypertension (OHT) – defined as elevated IOP antagonists (e.g., timolol, betaxolol), carbonic but no evidence of optic disc damage or visual anhydrase inhibitors (e.g., dorzolamide [Tru- field loss. A controlled trial involving 1636 sopt®, Merck & Co.], brinzolamide [Azopt®, patients with OHT (IOP between 24 and Alcon Laboratories]), cholinergics (e.g., pilo- 32 mmHg in the most impaired eye) conclu- carpine), α-adrenergic agonists (e.g., brimonidine sively demonstrated that lowering IOP by 20% [Alphagan®P, Allergan Inc.]), prostaglandins (or to no more than 24 mmHg) halves the risk of (e.g., latanoprost [Xalatan®, Pharmacia & the development of OAG [7]. In the accompany- Upjohn], travoprost [Travatan®, Alcon laborato- ing editorial [8], it is concluded that lowering IOP ries]), and the prostamide bimatoprost (Lumi- helps preserve visual function in OAG, NTG, gan®, Allergan Inc). In choosing among these and OHT, and for patients with each of these medications, both efficacy and safety/tolerability diagnoses, a 3 mmHg reduction in IOP roughly issues should be considered. Except for β-block- corresponds to a 50% reduction in the risk of the ers, which have been associated with rare but seri- development or progression of glaucoma. ous cardiopulmonary events [16], the ocular Achieving a low target pressure at a single time hypotensive agents commonly used seem to be point is insufficient to prevent the progression of systemically safe and are generally well tolerated. glaucomatous damage as it is likely that even The most appropriate medication, therefore, will transient elevations of IOP can cause damage to often be the one that is most efficacious in the optic nerve. Therefore, for the best protec- lowering and stabilizing IOP. tion of the visual field of glaucoma and OHT In evaluating the IOP-lowering efficacy of a patients, low pressures must be sustained medication, it is important to consider both through 24 h. IOP normally fluctuates through- mean IOP lowering and reliability of the medi- out the day and night in a circadian rhythm [9], cation in helping patients achieve target pres- and pressure peaks can occur at any time during sures. Further, the mechanism of IOP lowering the day or night [10–12]. may also be a key consideration in evaluating Glaucoma patients typically have larger diur- drug efficacy. The elevated IOP in glaucoma is nal variations in IOP compared with normal caused by impaired aqueous outflow [17]. A med- subjects. Large diurnal IOP fluctuations are a ication that lowers IOP by decreasing aqueous clinical concern, because they have been associ- production does not treat the physiological ated both with an increased risk of the develop- pathology in glaucoma, and it might cause addi- ment of glaucoma and an increased risk of tional damage to the outflow channels [18]. Con- glaucomatous progression. In concurrence with versely, a medication that increases tonographic earlier studies, Asrani and colleagues demon- outflow facility (trabecular meshwork ouflow) strated that large diurnal IOP fluctuations are a corrects the deficit that leads to elevated IOP. A risk factor for visual field loss in glaucoma inde- medication that enhances outflow facility may pendent of the level of IOP [13]. Thus, treatment also be preferred for therapy, as it could be best that prevents fluctuations in IOP should able to dampen pressure spikes and provide flat improve the prognosis of glaucoma patients. diurnal IOP curves [19,20]. Although other treatment strategies may even- Among the ocular hypotensive medications tually be used for glaucoma patients, such as that are currently available, bimatoprost stands neuroprotection, the current goal of glaucoma out for its IOP-lowering efficacy. therapy is to lower and stabilize IOP. In clinical practice, many physicians set a target pressure for Background on bimatoprost their patients to achieve on long-term therapy. Bimatoprost is a synthetic prostamide analog Factors that should be considered in setting an that reduces IOP by increasing aqueous humor appropriate target pressure include the IOP level outflow through a dual mechanism of action, at which optic nerve damage occurred, the rate improving both pressure-dependent (presumed and extent of glaucomatous damage, patient age trabecular, via Schlemm’s canal and the episcleral 32 Therapy (2004) 1(1) Lumigan® – DRUG PROFILE veins) and pressure-independent (presumed uve- addressing this question, though this data is not oscleral, ciliary
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