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
“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
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.
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