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Latanoprost

An Update of its Use in Glaucoma and Ocular Hypertension

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Summary

Abstract

Latanoprost (Xalatan®) is an ester analogue of prostaglandin F2α that reduces intraocular pressure (IOP) by increasing uveoscleral outflow. The IOP-lowering efficacy of latanoprost 0.005% lasts for up to 24 hours after a single topical dose, which allows for a once-daily dosage regimen.

In patients with ocular hypertension or open-angle glaucoma, a single drop of latanoprost 0.005% solution (about 1.5 µg) administered topically once daily reduced diurnal IOP by 22 to 39% over 1 to 12 months’ treatment in well-controlled trials; efficacy was maintained during treatment periods of up to 2 years. At this dosage, latanoprost was significantly more effective than timolol 0.5% twice daily in 3 of 4 large, double-blind, randomised studies, was generally as effective as bimatoprost or travoprost, and was significantly more effective than dorzolamide, brimonidine or unoprostone. Furthermore, in patients whose IOP was poorly controlled with timolol, switching to latanoprost monotherapy was at least as effective at lowering IOP as adding dorzolamide or pilocarpine to the regimen. Latanoprost has also shown significant additive effects when used in combination with one or more other glaucoma medications. The fixed combination of latanoprost plus timolol was significantly more effective than either of its individual components in two double-blind randomised studies and more effective than the fixed combination of dorzolamide and timolol in a 3-month, evaluator-masked study.

Data in patients with angle-closure glaucoma are limited, but in patients with elevated IOP after undergoing iridotomy, latanoprost 0.005% once daily was significantly more effective than timolol 0.5% twice daily at reducing IOP over 12 weeks of treatment in a large double-blind, randomised study.

Latanoprost is generally well tolerated and, unlike timolol, induces minimal systemic adverse events. In well-controlled, 6-month trials, the most commonly occurring drug-related ocular events in latanoprost recipients were mild to moderate conjunctival hyperaemia (3 to 15%) and iris colour change (2 to 9%); these seldom required patient withdrawal although the latter may be permanent.

Latanoprost 0.005% as a single daily drop has shown good IOP-lowering efficacy in patients with open-angle glaucoma or ocular hypertension and does not produce the cardiopulmonary adverse effects associated with β-blockers. Thus, latanoprost is a valuable addition to the first-line treatment options for patients with open-angle glaucoma or ocular hypertension. In addition, adjunctive treatment with latanoprost in patients who are refractory to β-blocker therapy is a viable, second-line treatment option. Although preliminary findings are promising, wider clinical experience is required to define the place of latanoprost in the treatment of angle-closure glaucoma.

Pharmacodynamic Properties

Latanoprost is an ester prodrug analogue of prostaglandin F2α with a high selectivity for the FP subtype of prostanoid receptors. Like other topically applied prostaglandins, latanoprost reduces intraocular pressure (IOP) by increasing uveoscleral outflow facility.

IOP reductions were maximal within 8 to 12 hours after a single topical dose of latanoprost (0.005%), and IOP remained below pretreatment levels for at least 24 hours. In addition, latanoprost showed little or no effect on aqueous humour flow, tonographic or fluorophotometric outflow facility, and did not disrupt the blood-aqueous barrier over short-term or long-term treatment. It is thought that the iridial darkening induced by latanoprost is due to enhanced melanin production.

Latanoprost 0.005% once daily either increased or had no appreciable effect on ocular circulation in patients with ocular hypertension or open-angle glaucoma. In one investigation, latanoprost increased diurnal ocular perfusion pressure to a significantly greater extent than timolol in patients with normal-tension glaucoma.

Results from one study investigating the effects of latanoprost in in vitro and/or in vivo models of retinal injury suggest that this agent may have neuroprotective effects.

Pharmacokinetic Properties

In patients undergoing cataract surgery the mean maximum concentration (Cmax) of latanoprost in the aqueous humour was 32.6 µg/L, the elimination half life (t½) was 2.5 hours and the concentration 24 hours after administration was ≤0.2 µg/L.

Following topical administration of latanoprost (30µL of a 50 µg/mL solution), t½ was 17 minutes, the area under the latanoprost plasma concentration time curve was 34 ng·h/L, and volume of distribution was 0.36 L/kg. Plasma Cmax after topical application of latanoprost was 53 ng/L after 5 minutes.

In healthy volunteers, 87.9% of a radiolabelled latanoprost dose was recovered in the urine and 15.3% in the faeces after topical administration.

Clinical Efficacy

The IOP-lowering efficacy of latanoprost ophthalmic solution (0.005%; 50 µg/mL) has been evaluated in patients with ocular hypertension or open-angle glaucoma, angle-closure glaucoma and other types of glaucoma. Latanoprost was administered as a single drop (about 1.5µg) once daily in all studies (unless otherwise indicated).

Open-Angle Glaucoma or Ocular Hypertension: In well-controlled clinical trials including patients with open-angle glaucoma or ocular hypertension (IOP ≥21mm Hg), monotherapy with latanoprost reduced IOP levels by 22 to 39% over 1 to 12 months’ treatment. Latanoprost was significantly more effective than timolol 0.5% twice daily in 3 of 4 large (n = 163 to 267) randomised, double-blind trials. In these studies, mean baseline diurnal IOP was reduced by 6.2 to 8.6mm Hg (27 to 35%) with latanoprost and 4.4 to 8.3mm Hg (19 to 33%) with timolol over 3 or 6 months of treatment. Latanoprost demonstrated a stable long-term IOP-lowering effect in 1- or 2-year continuations of these trials, with no sign of diminishing effect during prolonged treatment.

In other randomised studies, latanoprost was generally as effective as bimatoprost (0.3% once daily) or travoprost (0.0015 or 0.004% once daily), and was significantly more effective than dorzolamide (2% three times daily), brimonidine (0.2% twice daily), or unoprostone (0.12 or 0.15% twice daily) at reducing IOP over 1 to 12 months’ treatment.

In patients who had elevated IOP despite timolol treatment, switching to latanoprost monotherapy was at least as effective at reducing diurnal IOP as adding dorzolamide (2% twice daily) or pilocarpine (2% three times daily) to the regimen: mean diurnal IOP was reduced by 19 to 26%, 17 to 21% and 19 to 20%, respectively, over 6 weeks’ to 6 months’ treatment in randomised studies (n = 35 to 197).

The fixed combination of latanoprost plus timolol was significantly more effective than either of its individual components in two 6-month double-blind randomised studies and was also more effective than the fixed combination of dorzolamide plus timolol in a 3-month, evaluator masked study. When added to existing therapy with a β-blocker (usually timolol), latanoprost was significantly more effective than pilocarpine (2% three times daily) and dorzolamide (2% twice daily), and as effective as brimonidine (0.2% twice daily) at reducing IOP in randomised studies. Mean IOP was reduced by 24 to 32% with adjunctive latanoprost, 19 to 21% with adjunctive pilocarpine, 20% with adjunctive dorzolamide and 22% with adjunctive brimonidine. Latanoprost also demonstrated additive effects when used in combination with a variety of other IOP-lowering medications including dipivefrine, acetazolamide, dorzolamide and pilocarpine (but not unoprostone) in other studies.

In patients who had persistently elevated IOP despite receiving two or more IOP-lowering medications, latanoprost reduced IOP by a further 16 to 18% in noncomparative trials. In the only randomised study, latanoprost showed similar IOP-lowering efficacy to brimonidine 0.2% twice daily when these drugs were added to therapy with a β-blocker combined with pilocarpine or dorzolamide.

Angle-Closure Glaucoma: In patients who had elevated IOP despite iridotomy and/or iridectomy (including patients of Asian decent), latanoprost (0.005% once daily) was significantly more effective than timolol (0.5% twice daily) in two double-blind, monotherapy trials (8.2 and 8.8mm Hg vs 5.2 and 5.7mm Hg for latanoprost vs timolol at 12 and 2 weeks, respectively).

As adjunctive therapy in a small nonblind trial (patients had undergone iridectomy and were receiving combined treatment with β-blockers and pilocarpine with or without oral carbonic anhydrase inhibitors), latanoprost rapidly decreased mean IOP.

Other Types of Glaucoma: In randomised studies in patients with normal-tension glaucoma or steroid-induced glaucoma, latanoprost (0.005% once daily) displayed similar IOP-lowering efficacy to timolol 0.5% twice daily over 3 weeks or 4 months’ treatment, respectively. In patients with pigmentary glaucoma (n = 36), latanoprost produced significantly greater reductions in IOP than timolol after 12 months therapy (5.9 vs 4.6%).

Tolerability

Overall, ocular-related adverse effects observed in patients with glaucoma who received latanoprost were mild to moderate in severity and the majority resolved after discontinuation of treatment. Treatment with latanoprost may cause mild conjunctival hyperaemia, iridial darkening and eyelash changes. Increased iridial pigmentation did not resolve upon cessation of latanoprost in patients followed for 2 years.

An increase in the severity and recurrence of herpes simplex virus keratitis has been reported after initiation of latanoprost therapy and caution is advised in patients with a history of herpes. Anecdotal evidence has suggested development of cystoid macular oedema as a potentially serious adverse effect associated with latanoprost treatment in patients with independent risk factors. Anterior uveitis has also been observed in approximately 1% of patients receiving latanoprost and is resolved with corticosteroid therapy. Administration of latanoprost to patients with active uveitis at the time of treatment may or may not aggravate the condition, but does not appear to lower IOP.

Latanoprost-related systemic adverse events are infrequent (unlike those induced by timolol) but include respiratory complications and headache. A similar incidence of adverse effects has been observed in short-term (range 30 days to 8 weeks) randomised studies of latanoprost with the prostaglandins bimatoprost or unoprostone, although in one study unoprostone recipients experienced more frequent adverse events than latanoprost recipients. Significantly more conjunctive hyperaemia and increased eyelash growth was reported in patients who received bimatoprost than latanoprost for 3 months and headache was more frequently seen in latanoprost than bimatoprost patients. Latanoprost has also shown a similar incidence of adverse effects to both dorzolamide and brimonidine; systemic effects are more pronounced with dorzolamide.

Dosage and Administration

In the US, Europe and Japan latanoprost is approved for first-line use in patients with open-angle glaucoma or ocular hypertension.

A single drop of latanoprost 0.005% ophthalmic solution (about 1.5µg) once daily is the recommended dosage.

The drug should be used cautiously in patients with renal or hepatic impairment and in patients with active intraocular inflammation (e.g. iritis, uveitis). Contact lenses should be removed before administration of latanoprost.

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  1. Use of tradename is for product identification purposes only and does not imply endorsement.

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    Caroline M. Perry, Jane K. McGavin, Christine R. Culy & Tim Ibbotson

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Perry, C.M., McGavin, J.K., Culy, C.R. et al. Latanoprost. Drugs Aging 20, 597–630 (2003). https://doi.org/10.2165/00002512-200320080-00005

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