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FOR RELEASE 6/1/2011, Wednesday

Yellox™ (Bromfenac sodium sesquihydrate), the First and Only Twice-Daily Ocular NSAID, Approved by the European Commission Following Positive Opinion from CHMP

Vienna, Austria and Berlin, Germany – CROMA Pharma, GmbH (Croma), a private global specialty pharmaceutical and surgical company and Bausch + Lomb, the global eye health company, today announced the approval of Yellox ™ (Bromfenac sodium sesquihydrate) by the European commission. This news follows the positive opinion issued earlier in March by the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA).

Yellox, a non-steroidal anti-inflammatory drug (NSAID), is now approved for the treatment of postoperative ocular inflammation following cataract extraction in adults. Cataract surgery is one of the most common surgeries worldwide.

CROMA, the holder of the Yellox Marketing Authorization, filed its application through the EU- centralized approval procedure seeking simultaneous approval in all 27 member states. Yellox is the first ocular NSAID dosed twice a day to receive such an approval.

CROMA and Bausch + Lomb will co-promote Yellox in Austria, France, Spain, Poland and Romania; Bausch + Lomb will promote Yellox in the remaining EU member states.
 
“We are extremely pleased with marketing authorization from the European Medicines Agency.” said Andreas Prinz Managing Director of Croma Pharma GmbH, “Yellox is an innovative advance for the millions of post cataract surgical patients and offers physicians a new, powerful and convenient choice for helping to put a stop to ocular inflammation after cataract surgery.” 

“Yellox is very promising for cataract surgery patients.” said Dr. Cal Roberts, chief medical officer, Bausch + Lomb. “The drug helps meet the unmet needs of both patients and physicians alike across a number of European markets, offering them a new choice to treat post-operative ocular inflammation following cataract extraction.”  

Financial terms of the agreement between CROMA GmbH and Bausch + Lomb were not disclosed.

About Yellox™ (Bromfenac sodium sesquihydrate)

Bromfenac sodium sesquihydrate is a distinctive 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 high 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 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.

About CROMA
CROMA Pharma, GmbH, is a private global specialty pharmaceutical and surgical company dedicated to improving people’s health through the development and commercialization of innovative products in the ophthalmology, osteoarthritis and aesthetic dermatology fields. Founded in 1976, the company is headquartered in Leobendorf, Austria (near Vienna) and employs approximately 400 individuals at its headquarters and subsidiaries in Austria, Germany, France, Poland, Romania Spain and the USA. Today as a global player Croma distributes its products in 62 countries via its own commercial sales organization(s), strategic partnerships and distributors. More information is available at www.croma.at

About Bausch + Lomb
Bausch + Lomb 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.

Yellox is a registered trademark of Croma Pharma GmbH.
Bausch + Lomb is a registered trademark of Bausch & Lomb Incorporated.
© Bausch & Lomb Incorporated.

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