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Back To Vidyya FDA Approves Rescula, A New Docosanoid, For Glaucoma

Compound For Glaucoma Marketed by CIBA Vision

Ciba Vision, The Eye Care Unit Of Novartis, Announced Today That The U.S. Food And Drug Administration (FDA) Has Approved Rescula® (Unoprostone Isopropyl Ophthalmic Solution) 0.15%, A New Synthetic Docosanoid Compound For The Treatment Of Open-Angle Glaucoma Or Ocular Hypertension.

Rescula differs from other anti-glaucoma drugs in that it is the only available ocular therapy containing a docosanoid. Rescula consistently and safely lowers intraocular pressure (IOP) when used as either a monotherapy or in combination with other drugs, and IOP reduction is maintained at a constant level throughout the day. In clinical studies Rescula shows no loss of efficacy over 12 months.

"With this approval, we are now able to provide doctors with a major new building block in glaucoma treatment," said Dan Myers, president of CIBA Vision's North American Ophthalmics group. "Research shows that unlike non- cardioselective beta blockers, Rescula safely lowers intraocular pressure without affecting cardiovascular or pulmonary function."

The most common ocular adverse events with Rescula (occurring in 10-25% of patients during clinical studies) were burning/stinging, burning and stinging upon instillation, dry eyes, itching, increased length of eyelashes and injection(redness).

Patients will use Rescula, in the form of eye drops, twice a day. It rapidly penetrates the cornea, achieving maximum effects in as soon as 24 hours.

"It's very exciting and important that we have as many different options as possible, including Rescula, in the medical treatment of glaucoma," said Tom Mundorf, MD, a glaucoma specialist in Charlotte, N.C. "We're learning in preliminary research that many of these medicines, in addition to lowering pressure in the eye, may one day prove to have other additional benefits to the health of the eye."**

FDA approval of Rescula was based upon clinical studies in which more than 1,100 patients were studied for up to 12 months at more than 50 study sites in the US, Canada, Europe and Israel.

Rescula at a 0.12% concentration is currently marketed in more than 25 countries globally. It has been licensed from Ueno Fine Chemicals Industry, Ltd. and R-Tech Ueno, Ltd. of Japan, where more than 500,000 patients have been treated over the last six years. Glaucoma is an eye disease affecting an estimated 4 million people in the US and 5 million in Europe, and is one of the leading causes of preventable blindness.

About Docosanoids

Docosanoids are lipids with 22-carbon atoms. Naturally occurring docosanoids are derived from docosahexaenoic acid. Numerous published reports (in both human and animal studies) have shown that docosahexaenoic acid is essential in the development and functioning of the retina.

About Glaucoma

Glaucoma is one of the leading causes of blindness in the US. As many as 30 different types of the disease exist. Although the clinical features of glaucoma are reasonably understood, the pathogenesis of optic nerve damage remains unclear. Elevated IOP remains a well-accepted and important risk factor in the development of the disease; however, current understandings require definitions that are multi-factorial or multi-dimensional.

In the early stages of the disease, glaucoma usually has no noticeable symptoms. Loss of vision occurs in the late stages of the disease. However, through early detection and continuing treatment, glaucoma usually can be controlled and blindness prevented.

Patients with any type of glaucoma therapy sometimes get worse. As a result, treatments may need to be changed. It is important for patients to visit their eye care professionals regularly.

Rescula® is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of other intraocular pressure lowering medications or insufficiently unresponsive (failed to achieve target IOP determined after multiple measurements over time) to another intraocular pressure lowering medication.

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Editor: Susan K. Boyer, RN
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