Speaker Series: Treatment Options for Elevated IOP
in Patients With Open-Angle Glaucoma

Video discussions with Derek Cunningham, OD, Ben Gaddie, OD, and Paul Karpecki, OD

Merck

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Overview of ZIOPTAN® (tafluprost ophthalmic solution 0.0015%)

Derek Cunningham, OD, Paul Karpecki, OD, and Ben Gaddie, OD, share important safety information about the demonstrated safety profile and efficacy of ZIOPTAN®, a once-daily, preservative-free prostaglandin analog. The panel reviews clinical data, up to 24 months in duration, as well as prescribing, storage, and handling information important to the patient.

Brought to you and funded by Merck

ZIOPTAN (tafluprost ophthalmic solution) 0.0015% is indicated for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

SELECT IMPORTANT SAFETY INFORMATION

  • ZIOPTAN has been reported to cause changes to pigmented tissues. The most frequently reported changes have been to the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as ZI OPTAN is administered. Pigmentation of the iris is likely to be permanent and may not be noticeable for several months to years, while pigmentation of the periorbital tissue and eyelash changes may be reversible in some patients. The long-term effects of increased pigmentation are not known.

See Additional Safety Information Below

COSOPT PF (dorzolamide hydrochloride-timolol maleate ophthalmic solution) 2%/0.5%) is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of COSOPT administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2.0% dorzolamide administered 3 times a day.

SELECT IMPORTANT SAFETY INFORMATION

  • COSOPT PF is contraindicated in patients with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second- or third-degree atrioventricular block, overt cardiac failure, cardiogenic shock, or hypersensitivity to any component of this product.

See Additional Safety Information Below

Select Important Safety Information

  • ZIOPTAN may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, color, thickness, shape, and number of lashes. Eyelash changes are usually reversible on discontinuation of treatment.

  • ZIOPTAN should be used with caution in patients with active intraocular inflammation (eg, iritis/uveitis) because the inflammation may be exacerbated.

  • Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin F2a analogs. ZIOPTAN should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

  • In clinical trials of patients receiving either preservative-containing or preservative-free ZIOPTAN, the most common pooled adverse reaction observed was conjunctival hyperemia, which was reported in a range of 4% to 20% of patients.

Select Important Safety Information

  • COSOPT PF contains timolol maleate, a beta-adrenergic blocking agent; and although administered topically, it is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to systemic administration of beta-adrenergic blocking agents may occur with topical administration of COSOPT PF. For example, severe respiratory reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate.

  • Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure. In patients without a history of cardiac failure, continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, COSOPT PF should be discontinued.

  • COSOPT PF contains dorzolamide, a sulfonamide; and although administered topically, it is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration of COSOPT PF. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides, including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias.

  • Patients with chronic obstructive pulmonary disease (eg, chronic bronchitis, emphysema) of mild or moderate severity, bronchospastic disease, or a history of bronchospastic disease (other than bronchial asthma or a history of bronchial asthma, in which COSOPT PF is contraindicated) should, in general, not receive beta-blocking agents, including COSOPT PF.

  • While taking beta-blockers, patients may be more reactive to allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.

  • Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (eg, diplopia, ptosis, and generalized weakness).

  • Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia.

  • Beta-adrenergic blocking agents may also mask certain clinical signs (eg, tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents that might precipitate a thyroid storm.

  • Dorzolamide has not been studied in patients with severe renal impairment (CrCl <30 mL/min). Because dorzolamide and its metabolite are excreted predominantly by the kidney, COSOPT PF is not recommended in such patients. Dorzolamide has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients.

  • Some patients receiving beta-adrenergic receptor blocking agents have experienced protracted severe hypotension during anesthesia. Difficulty in restarting and maintaining the heartbeat has also been reported. For these reasons, in patients undergoing elective surgery, some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking agents.

  • There is an increased potential for developing corneal edema in patients with low endothelial cell counts. Caution should be used when prescribing COSOPT PF to this group of patients.

  • In clinical trials evaluating COSOPT and COSOPT PF, approximately 5% of all patients discontinued therapy because of adverse reactions. The most frequently reported adverse reactions occurring in up to 30% of patients were taste perversion (bitter, sour, or unusual taste) or ocular burning and/or stinging. The following adverse reactions were reported in 5% to 15% of patients: conjunctival hyperemia, blurred vision, superficial punctate keratitis, or eye itching.

  • Due to the potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition, the concomitant administration of COSOPT PF and oral carbonic anhydrase inhibitors is not recommended. The concomitant use of 2 topical beta-adrenergic blocking agents is not recommended, and patients receiving a beta-adrenergic blocking agent orally and COSOPT PF should be observed for potential additive effects of beta-blockade, both systemic and on IOP.

  • The potential for acid-base and electrolyte disturbances should be considered in patients receiving COSOPT PF. Caution should be used with coadministration of calcium antagonists because of possible atrioventricular conduction disturbances, left ventricular failure, and hypotension, and should be avoided in patients with impaired cardiac function. Close observation is recommended with coadministration of catecholamine-depleting drugs because of possible additive effects and the production of hypotension and/or marked bradycardia. The concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time. Potentiated systemic beta-blockade has been reported during combined treatment with CYP2D6 inhibitors and timolol.

  • There are no adequate and well-controlled studies in pregnant women. COSOPT PF should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

  • It is not known whether dorzolamide is excreted in human milk. Timolol maleate has been detected in human milk following oral and ophthalmic drug administration. Because of the potential for serious adverse reactions from COSOPT PF in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

  • The dose is 1 drop of COSOPT PF in the affected eye(s) 2 times daily.

  • If more than 1 topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart.

  • The solution from 1 individual unit is to be used immediately after opening for administration to 1 or both eyes. Since sterility cannot be maintained after the individual unit is opened, the remaining contents should be discarded immediately after administration.