FDA Approves Dorzolamide for Lowering Intraocular Pressure


FDA Approves Dorzolamide for Lowering Intraocular PressureIn late 2014 the FDA approved Dorzolamide Hydrochloride, to be used in conjunction with Timolol Maleate for the treatment of increased intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Known as the brand name eye drop Cosopt Opthamolic Solution, which is marketed by Lannett Company Inc., this solution has proven to be both safe and effectual. Dorzolamide Hydrochloride and Timolol Maleate is available in the newly approved 2%/0.5% opthamolic solution, and it is specifically indicated for patients who were insufficiently responsive to prior beta-blocker treatment. As an effective beta-adrenergic receptor blocking therapy, as well as a topical carbonic anhydrase inhibitor, the Dorzolamide and Timolol duo has proven to be a formidable opponent against elevated intraocular pressure.

One successful study of Dorzolamide and Timolol involved 1,035 patients who were diagnosed with elevated intraocular pressure alongside the diagnosis of either ocular hypertension or open-angle glaucoma. Discontinuation of the opthamolic solution occurred in only 5 percent of patients, who felt the adverse effects of a stinging sensation in the eyes and taste perversion were bothersome. However, the vast majority of patients who received Cosopt (Dorzolamide and Timolol) did not experience negative side effects causing them to withdraw from the study. The typical dosage for the Dorzolamide/Timolol therapy is one drop in each affected eye two times daily. It is advisable for patients to administer the drops as close to every 12 hours as possible. Contact lens wearers should avoid placing lenses in their eyes until at least ten minutes have passed after drop administration. Other eye drops that patients may use must also be administered at least 10 minutes after using Dorzolamide and Timolol. Commonly reported side effects include eye irritation, such as stinging or itchiness immediately after drop administration, as well as slight blurriness. These effects have proven to be mild and not noticeable throughout the day for the majority of patients.

Elevated intraocular pressure is a common symptom of open-angle glaucoma. As the number one cause of irreversible blindness both in the United States and around the globe, continued R&D is greatly needed for new therapies to treat the ever growing patient population suffering from glaucoma. Current data indicates that over 3 million Americans are living with a glaucoma diagnosis, with 2.7 million of these patients age 40 and older. The aging population worldwide has led to predictions of glaucoma cases to balloon to 80 million people by the year 2020.

LGM Pharma can assist clients as a supplier/distributor of Dorzolamide Hydrochloride CAS# 130693-82-2 and Timolol Maleate CAS# 26921-17-5 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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