What Istalol Treats

Ocular Hypertension

There are millions of people in the United States who have increased pressure in their eyes (intraocular pressure) without glaucoma. Often this condition is referred to as ocular hypertension. Some of these people eventually develop glaucoma and loss of vision, whereas others lead their lives without developing the disease. One of the largest studies of ocular hypertension, the Ocular Hypertension Treatment Study (OHTS), proved that topical medication reduces the incidence of glaucoma and supports offering eyedrop treatment to ocular hypertensive people who are at moderate to high risk for developing glaucoma.

Open-Angle Glaucoma

This is the most common form of glaucoma, affecting about three million Americans. Open-Angle glaucoma occurs when the eye’s drainage canals become clogged over time. The inner eye pressure (also called intraocular pressure or IOP) rises because the correct amount of fluid cannot drain out of the eye. With open angle glaucoma, the surface of the drainage canals are clear and should be working correctly. The clogging problem occurs further inside the drainage canals, similar to a clogged pipe below the drain in a sink.

Most people have no symptoms and no early warning signs. If open-angle glaucoma is not diagnosed and treated, it can cause gradual and permanent loss of vision that develops slowly and sometimes without notice. It usually responds well to medication, especially if caught early and treated. Keeping the IOP under control is the key to preventing loss of vision from glaucoma.

About Istalol

Istalol is a once-daily beta-blocking agent for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma¹. Istalol, formulated with potassium sorbate, has been shown to have 3X the ocular bioavailability² and 75% less systemic absorption³ vs. other timolol solutions. Providing 24-hour control with minimal diurnal fluctuation and convenient morning dosing, Istalol is an excellent choice for monotherapy, or as an adjunct to a prostaglandin¹.

In a well controlled, double-masked, parallel study of 332 patients with untreated intraocular pressures of 22 mm Hg or greater, Istalol administered once daily (AM) was equivalent to timolol maleate oph­thalmic solution 0.5% administered twice daily⁴. In both groups, mean intraocular pressure decreased from 25 mm Hg at baseline to 18 mm Hg at peak and 19 mm Hg at trough⁴. Istalol has been shown to be safe, effective, and generally well tolerated in multiple studies with only 3% of patients discontinuing use due to adverse events over a 12 month period.

Contraindications, Warnings, Adverse Reactions

ISTALOL is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see WARNINGS/full package insert); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see WARNINGS/full package insert); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.

As with many topically applied ophthalmic drugs, this drug is absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac 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 (see CONTRAINDICATIONS/full package insert).¹

The most frequently reported adverse experiences have been burning and stinging upon instillation in 38% of patients treated with ISTALOL. Additional events reported with ISTALOL at a frequency of 4 to 10% include: blurred vision, cataract, conjunctival infection, itching and decreased visual acuity.

See full prescribing information

References:

1. Istalol [Package Insert]. ISTA Pharmaceuticals, Inc., Irvine, CA.
2. Higashiyama M, Inada K, Ohtori A, et al. Improvement of the ocular bioavailability of timolol by sorbic acid. Int J Pharm. 2004;272:91-98.
3. Mundorf TK, Ogawa T, Inui N, et al. Timolol LA: a double-masked, active-controlled, randomized, crossover, comfort, ocular safety, and systemic bioavailability study in healthy volunteers. Curr Med Res Opin. 2005;21:369-373.
4. Mundorf TK, Ogawa T, Naka H, et al. A 12-month, multicenter, randomized, double-masked, parallel-group comparison fo timolol-LA once daily and timolol maleate ophthalmic solution twice daily in the treatment of adults with glaucoma or ocular hypertension. Clin Ther. 2004;26:541-551.