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FOR RELEASE 5/9/2013, Thursday

Bausch + Lomb Reports Fourth Year of Data on Patterns of Bacterial Resistance in Ocular Infections

National ARMOR Surveillance Study Results Presented at 2013 ARVO Annual Meeting

Additional Posters Describe the Characterization and Distribution of Pathogens in Bacterial Conjunctivitis

ROCHESTER, NY — Researchers from Bausch + Lomb, the global eye health company, reported the most recent findings of the ARMOR (Antibiotic Resistance Monitoring in Ocular MicroRganisms) surveillance study, the only national survey of antibiotic resistance patterns in eye care, at the 2013 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Seattle, Washington.1  Company scientists also presented data that examined changing patterns in the type and distribution of other disease-causing organisms,2 and characterized methicillin-resistant Staphylococcus aureus (MRSA),3 in bacterial conjunctivitis.

For the fourth consecutive year, ARMOR study participants collected bacterial isolates of known ocular pathogens and subjected them to antibiotic susceptibility testing.  The 2012 data set included 456 isolates of Streptococcus pneumoniae, Staphylococcus aureus, coagulase-negative staphylococci (CoNS), Pseudomonas aeruginosa, and Haemophilus influenzae from 25 sites across the United States.1 

Study authors reported that resistance rates have remained relatively stable over the four-year period, with the new data reducing some of the fluctuation seen in previous years.  However, a number of bacterial isolates demonstrated resistance to many commonly used antibiotics.  For example, more than 33 percent of S. aureus and CoNS isolates were resistant to three or more antibiotics, especially MRSA and methicillin-resistant CoNS isolates which were multi-drug resistant more than 73 percent of the time.1

"Because clinicians treat bacterial conjunctivitis empirically in the majority of cases, the data collected in the ongoing ARMOR study is critically important to guide therapeutic decision-making," commented Terrence P. O'Brien, M.D., Charlotte Breyer Rodgers Distinguished Chair in Ophthalmology and Co-Director of the Ocular Microbiology Laboratory, Bascom Palmer Eye Institute, University of Miami.  "Knowing the type and proportion of ocular pathogens that are potentially resistant, as well as the antibiotics to which they are less susceptible, allows selection of agents that have a broad spectrum of activity and proven efficacy against potentially sight-threatening organisms like P. aeruginosa and difficult-to-treat strains including MRSA.  In light of the growing problem of bacterial resistance in the community and in medicine generally, the authors' conclusion that continued vigilance is warranted is exceptionally prudent."

In a second study, investigators compared the prevalence and distribution of ocular pathogens in recent (2009-2011) bacterial conjunctivitis clinical trials to earlier studies (2004-2007).2,4  A total of 2,348 isolates were recovered from 3,379 patients enrolled in five multicenter, randomized, double-masked clinical studies evaluating Besivance® (besifloxacin ophthalmic suspension) 0.6%, of which 1,324 isolates were from the earlier period and 1,024 isolates from the later.  All isolates were evaluated for baseline frequency, microbial eradication, and antimicrobial susceptibility profiles.  While the five most frequently isolated bacterial species remained the predominant conjunctivitis pathogens across all five trials, the researchers identified 15 uncommon pathogens in the more recent set of studies. 

Company researchers also examined bacterial isolates from both clinical conjunctivitis trials and surveillance studies to determine how frequently two different types of MRSA, the often multi-drug resistant hospital-acquired (HA) MRSA or the more virulent community- acquired (CA) variety, could be identified.3  They identified 27 MRSA isolates during three clinical studies conducted between 2004-2007 and 298 from the 2009-2011 ARMOR surveillance studies.  Both groups contained similar and roughly equal ratios of the two MRSA types, although isolates from the conjunctivitis trials showed a higher diversity in genetic lineages (spa types).  The researchers reported that both HA MRSA and CA MRSA could be implicated in bacterial infections of the eye in the clinical trials and the surveillance study.  This is of interest because both types of MRSA are a significant concern to health care practitioners.

About Besivance
Besivance® (besifloxacin ophthalmic suspension) 0.6 percent is  indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: Aerococcus viridans*, CDC coryneform group G, Corynebacterium pseudodiphtheriticum*, Corynebacterium striatum*, Haemophilus influenzae, Moraxella catarrhalis*, Moraxella lacunata*, Pseudomonas aeruginosa*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis*, Staphylococcus lugdunensis*, Staphylococcus warneri*, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, and Streptococcus salivarius.

*Efficacy for this organism was studied in fewer than 10 infections.

Dosage and Administration
Instill one drop into the affected eye(s) three times a day, four to 12 hours apart for seven days.

Dosage Forms and Strengths
Topical ophthalmic suspension:  besifloxacin ophthalmic suspension, 0.6 percent.

Important Risk Information about Besivance

  • Besivance is for topical ophthalmic use only, and should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.
  • As with other anti-infectives, prolonged use of Besivance may result in overgrowth of non-susceptible organisms, including fungi.  If super-infection occurs, discontinue use and institute alternative therapy.
  • Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with Besivance
  • The most common adverse event report in two percent of patients treated with Besivance   was conjunctival redness.  Other adverse events reported in patients receiving Besivance occurring in approximately one-two percent of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache.
  • Besivance is not intended to be administered systemically.  Quinolones administered systemically have been associated with hypersensitivity reactions, even following a single dose.  Patients should be advised to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction.
  • Safety and effectiveness in infants below one year of age have not been established.

Please visit www.bausch.com for full Prescribing Information for Besivance.

About Bausch + Lomb
Bausch + Lomb is a leading global eye health company that is solely focused on protecting, enhancing, and restoring people’s eyesight. Our core businesses include ophthalmic pharmaceuticals, contact lenses and lens care products, and ophthalmic surgical devices and instruments. We globally develop, manufacture and market one of the most comprehensive product portfolios in our industry, which are available in more than 100 countries.  Founded in 1853, our company is headquartered in Rochester, NY, and employs more than 11,000 people worldwide.


REFERENCES
 1. Haas W, Deane J, Morris TW, Sahm DF.  Antibiotic Resistance Surveillance of Ocular Pathogens - four years of ARMOR Study Results. [2904 - B0273. 8:30 – 10:15 am, Exhibit/Poster Hall, Clinical and Translational Studies in Ocular Infection and Immunity]

2. Gearinger LS, Sanfiglippo CM, Zhang L, Haas W, Comstock TL, Morris TW. Atypical Pathogens Observed in Recent Clinical Studies of Bacterial Conjunctivitis.  [5450 - A0149. 8:30 – 10:15 a.m., Exhibit/Poster Hall, Ocular Surface in Health and Disease]

3. Morris TW, Sanfilippo CM, Hesje CK, MacGilvray ME, Haas W.  Prevalence and characteristics of MRSA from clinicalconjunctivitis trials versus ocular surveillance studies.  [2886 - B0255. 8:30 – 10:15 a.m., Exhibit/Poster Hall, Clinical and Translational Studies in Ocular Infection and Immunity]