The Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), has released a positive opinion for the marketing authorization of Yellox™ (bromfenac) ophthalmic solution. Yellox is a non-steroidal anti-inflammatory drug (NSAID), designed for the treatment of postoperative ocular inflammation following cataract surgery.
If approved by the EU Commission, CROMA Pharma GmbH and Bausch + Lomb, Inc. would co-promote Yellox in France, Poland, Romania, Austria, and Spain. Bausch + Lomb would promote Yellox in the remaining EU member states. CROMA will be the holder of the Marketing Authorization, Bausch + Lomb is a commercial partner regarding this product.
“We are extremely pleased with the positive announcement from CHMP.” said Andreas Prinz managing director of CROMA Pharma GmbH, “Yellox is a novel advance for the millions of post cataract surgical patients and offers physicians a new, powerful and convenient choice.”
“This drug holds great promise for all patients.” said Dr. Cal Roberts, chief medical officer, Bausch + Lomb. “If approved by the EU Commission, Yellox would help meet the unmet needs of patients and physicians alike across a number of European markets, offering them a new choice to treat post-operative ocular inflammation following cataract extraction.”
Yellox was submitted to EMA by CROMA for centralized approval in 2009 throughout the European Union. Once approved, Yellox would be the first ocular NSAID dosed two times per day for use by patients in the EU. Other formulations of bromfenac have been approved for use in the U.S. since 2005 and Japan since 2000, where they are marketed by other companies.
Financial terms of the agreement between CROMA and Bausch + Lomb are not disclosed.
About Yellox™ (Bromfenac)
Bromfenac sodium sesquihydrate is a unique and highly potent NSAID which provides targeted inhibition of the COX-2 enzyme which, is thought to be the primary mediator of ocular inflammation through prostaglandin production. Dosed twice-daily, the ophthalmic solution shows increased lipophilicity, resulting in enhanced penetration through the cornea and ocular tissues for a rapid resolution of ocular inflammation2.
About NSAID Use in Post-Operative Cataract Extraction
Immediately following cataract extraction, patients are more susceptible to problems relating to ocular inflammation due to the surgical disruption of the blood ocular barrier. Non-steroidal anti-inflammatory (NSAIDs) are an important class of agents for the treatment of post-cataract surgery inflammation and as a way to minimize induced risk of surgery-induced cystoid macular edema, a long term complication of inflammation.
About Bausch + Lomb
Bausch + Lomb, Inc. is one of the best-known and most respected healthcare companies in the world. Its core businesses include contact lenses and lens care products, ophthalmic surgical devices and instruments, and ophthalmic pharmaceuticals. Founded in 1853, the company is headquartered in Rochester, N.Y., and employs more than 10,000 people worldwide. Its products are available in more than 100 countries. More information is available at www.bausch.com.
About CROMA
CROMA Pharma, GmbH, is a global pharmaceutical and surgical company dedicated to improving people’s Health through innovative, effective solutions. Founded in 1976, the company is headquartered in Leobendorf, Austria with subsidiaries in Germany, France, Poland, Romania Spain and the USA. More information is available at www.croma.at
1 Bakalayan GA et. al. J. Ocul Pharmacol Ther. 2008, 24(4):392-8
2 Donnenfeld ED, Donnenfeld A. Int Ophthalmol Clin. 2006; 46(4):21-40
Yellox is a registered trademark of Croma Pharma GmbH.
Bausch + Lomb is a registered trademark of Bausch & Lomb Incorporated.
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