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SALVAT launches Cetraflux

03/04/13

SALVAT launches the first sterile ophthalmic ciprofloxacin without preservatives

Cetraflux® 3 mg/ml, eye drops, solution is the first and only fluoroquinolone on the Spanish market supplied to ophthalmologists in sterile single-dose packs without preservatives.

In addition to the most common eye infections such as conjunctivitis or corneal ulcers, there is an important demand among eye surgeons for a first-choice antibiotic for pre- and post-surgical prophylaxis (in other words, a fluoroquinolone) in a sterile, single-dose format without preservatives that could damage the epithelial barrier of the cornea.

To date, the antibiotics available to specialists largely comprised non-sterile multiple-dose formats with potentially harmful preservatives such as benzalkonium chloride. It has been found that benzalkonium chloride, the preservative used in most multiple-dose eye drops, can damage the corneal tissue and cause lesions, especially in fine corneas. Other comparatively minor complications such as pruritus and red eyes are relatively commonly in association with the use of eye drops that contain this preservative among their excipients.

Many studies show that benzalkonium chloride (0.01%, the usual concentration in artificial tears and other multiple-dose eye drops) can cause significant epithelial damage. According to the same studies, and although they are less aggressive than benzalkonium chloride, other less common preservatives, such as polyquad (0.001%) or termosal (0.004%), also damage the cornea.

Widespread demand among eye surgeons

Spain leads the European ranking for sight-correction surgery (near-sightedness, far-sightedness or astigmatism), and the number has doubled in the last 10 years, currently standing at around 300,000 operations per year. During or after LASIK surgery (corneal refractive surgery with Excimer laser), which continues to be the most common technique used for this type of surgery, the corneal stroma can come into contact with infectious agents carried by the patient. According to specialists, other risk factors for post-surgical infection are possible rupture of the epithelial barrier, a delay in post-surgical corneal re-epithelisation, reduced corneal sensitivity or severe dry eye.

Although it is very low (1/5,000 cases), there is a risk of infection with potentially serious visual consequences and eye surgeons routinely use antibiotic prophylaxis, not only during surgery but a few days prior to and particularly during the post-operative period.

Protocols establish the use of fluoroquinolones as first-choice antibiotics before and after sight-correction surgery, whether the technique used is LASIK, PRK, LASEK or Epi-LASIK.

The use of fluoroquinolones in post-surgical prophylaxis is due to their broad spectrum of action. Although the bacteria most commonly involved in infections after eye surgery are gram positive (S. aureus), the involvement of other bacteria, including gram negative bacteria such as P. aeruginosa, cannot be entirely ruled out. In this respect, ciprofloxacin is believed to be more effective than other fourth-generation fluoroquinolones.

To manufacture single doses of Cetraflux®, Laboratorios SALVAT uses a unique technology in Spain (called Blow, Fill and Seal), which enables the use of a polymer with a low melting point. In practice, this means that it is less hard and therefore more practical and easy to use, especially by elderly people.

Each unit of Cetraflux® contains 30 single doses with 0.25 ml of eye drops each, so the total content is equivalent to that of other antibiotics in multiple-dose format.

Laboratorios SALVAT now leads the national market for topical fluoroquinolones with brands such as Cetraxal Ótico or Cetraxal Plus, which are first choice and generally used by ENT specialists, paediatricians and general practitioners for the treatment of otitis externa and chronic suppurative otitis media. In 2009, Laboratorios SALVAT was approved by the US FDA to market Cetraxal, its fluoroquinolone in sterile single doses in the United States. SALVAT also markets Cetraxal in other European, Latin American and African countries.



Laboratorios SALVAT S.A.
C\ Gall, 30-36 08950 - Esplugues de Llobregat - Barcelona España Tel. +34 933 946 400 Fax. +34 934 732 292 salvat@svt.com
1200 Brickell Avenue, Suite 1950, Miami, FL 33131 (US) Tel. +1 786-528-5273 salvatusa@svt.com