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24 September, 2018 00:00 00 AM
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FDA approves Xelpros (latanoprost ophthalmic emulsion) to treat open-angle glaucoma or ocular hypertension

drugs.com
FDA approves Xelpros (latanoprost ophthalmic emulsion) to treat open-angle glaucoma or ocular hypertension

Sun Pharmaceutical Industries Ltd. and Sun Pharma Advanced Research Company Ltd. (SPARC) recently announced U.S. Food and Drug Administration (USFDA) approval for the New Drug Application (NDA) of Xelpros (latanoprost ophthalmic emulsion) 0.005% for the reduction of elevated intraocular pressure (IOP, or pressure inside the eye) in patients with open-angle glaucoma or ocular hypertension.

Xelpros is the first and only form of latanoprost that is not formulated with benzalkonium chloride (BAK), a preservative commonly used in topical ocular preparations. Xelpros is developed using

SPARC’s proprietary Swollen Micelle Microemulsion (SMM) technology.

“As the only BAK-free version of latanoprost, Xelpros will be an important and alternative treatment option for individuals with open-angle glaucoma or ocular hypertension,” said Abhay Gandhi, CEO, North America, Sun Pharma. “This approval, coming less than one month following the approval of CEQUA™ (cyclosporine ophthalmic solution) 0.09%, reaffirms the strength of Sun Pharma’s fast-growing Ophthalmics division and its commitment to serving the needs of patients with ocular disorders.”

Anil Raghavan, CEO, SPARC said, “Approval of Xelpros by USFDA is a significant milestone for SPARC. It is also a validation of our SMM technology which helps to solubilize drugs that have limited or no solubility thus eliminating the need for benzalkonium chloride (BAK).”

In randomized, controlled clinical trials of patients with open-angle glaucoma or ocular hypertension with a mean baseline Intraocular pressure (IOP) of 23-26 mmHg, Xelpros lowered IOP by a mean of up to 6-8 mmHg.

Xelpros will be commercialized in the U.S. by Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceutical Industries Ltd.’s wholly owned subsidiary.

About Xelpros

Xelpros (latanoprost ophthalmic emulsion) 0.005%, a translucent ophthalmic emulsion, is a topical formulation of latanoprost, a prostaglandin analogue that is used as first-line treatment for open-angle glaucoma or ocular hypertension. It is the first and only BAK-free form of latanoprost.

The recommended dosage of Xelpros is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. Reduction of IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours.

Across multiple Xelpros clinical trials, the most frequently reported ocular adverse reactions were eye pain/stinging upon instillation and ocular hyperemia (redness), reported in 55% and 41% of patients treated with Xelpros, respectively. Less than 1% of patients discontinued therapy because of intolerance to these adverse events.

Important safety information

Contraindications

Xelpros is contraindicated in patients with known hypersensitivity to latanoprost, or any other ingredients in this product.

Warnings and precautions

Pigmentation: Xelpros may cause changes to pigmented tissues. The most frequently reported changes are increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as Xelpros is administered. After discontinuation of Xelpros iris pigmentation is likely to be permanent. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known.

Eyelash Changes: Xelpros may gradually cause changes to eyelashes, vellus hair in the treated eye including increased length, thickness, pigmentation and number of lashes. The changes are usually reversible upon discontinuation of treatment.

Intraocular Inflammation: Xelpros should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation.

Macular Edema: Xelpros 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.

Herpetic Keratitis: Xelpros should be used with caution in patients with a history of herpetic keratitis. Xelpros should be avoided in cases of active herpes simplex keratitis because inflammation may be exacerbated.

Bacterial Keratitis: There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products.

Use with Contact Lens: Contact lenses should be removed prior to administration of Xelpros and may be reinserted 15 minutes following administration.

Adverse reactions

The most common ocular adverse reactions reported in clinical trials (incidence ≥5%) for Xelpros are: eye pain/stinging, ocular hyperemia, conjunctival hyperemia, eye discharge, growth of eyelashes, and eyelash thickening.

Drug interactions

Precipitation may occur if drugs containing thimerosal are used concomitantly with Xelpros. If such drugs are used, they should be administered at least five (5) minutes apart.

About open-angle glaucoma

Open-angle glaucoma (also known as primary or chronic glaucoma) is the most common form of glaucoma, accounting for more than 90% of cases. It is caused by clogging of the drainage canals in the eye, resulting in elevated intraocular pressure (IOP). A lifelong condition, open-angle glaucoma develops slowly, causing ocular nerve damage that gradually affects a patient’s visual function.

In the U.S., glaucoma is a leading cause of irreversible blindness, second only to macular degeneration. More than 2.25 million Americans older than 40 years have open-angle glaucoma. Worldwide, glaucoma is the second leading cause of blindness, surpassed only by cataracts; more than 2 million people around the world will develop open-angle glaucoma each year, and more than 3 million are bilaterally blind (i.e., in both eyes) from open-angle glaucoma.

About ocular hypertension

Ocular hypertension is a condition in which IOP is greater than 21 mmHg, the widely accepted upper limit of normal IOP in the general population. In individuals with ocular hypertension, fluid from the front of the eye does not drain properly, causing IOP to build up. Although ocular hypertension can cause glaucoma, it is not the same as glaucoma; with ocular hypertension, the optic nerve appears normal and there are no signs of vision loss.

However, individuals with ocular hypertension are considered “glaucoma suspects,” and should visit their ophthalmologist regularly to be checked for glaucoma. Population studies in various countries suggest that ocular hypertension affects an estimated 4-10% of individuals older than 40 years. The prevalence of ocular hypertension is 10-15 times greater than that of open-angle glaucoma.

 

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Editor : M. Shamsur Rahman

Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

Editor : M. Shamsur Rahman
Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

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