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FOR RELEASE 5/1/2014, Thursday

Bausch + Lomb Highlights Scientific and Clinical Research in Various Therapeutic Areas during the Association for Research in Vision and Ophthalmology Annual Meeting in Orlando

FOR RELEASE THURSDAY, MAY 1, 2014

BRIDGEWATER, NJ — Bausch + Lomb, a leading global eye health company, will present a wide array of scientific posters during the Association for Research in Vision and Ophthalmology (ARVO) Annual meeting in Orlando, Fla. (May 4-8). The presentations will address the outcomes of research studies from the company’s current product offerings and pipeline programs in Pharmaceuticals, contact lenses and lens care, in addition to other subjects of interest. 

“Bausch + Lomb is dedicated to exploring new solutions and treatment options for eye health, including insights into macular degeneration and innovative ways to treat ocular inflammation that improve upon the current standard of care,” said Cal Roberts, MD, Chief Medical Officer, Bausch + Lomb. “Year after year, ARVO provides the ideal forum in which to share our latest research with the eye care community and help to refine and advance how eye care professionals meet the evolving needs of their patients.”

The research supported by Bausch + Lomb covers a variety of therapeutic areas including anti-infectives, wet macular degeneration, glaucoma, and ocular inflammation. Highlights of this new research include:

  • 2013 results from the Antibiotic Resistance Monitoring in Ocular Microorganisms (ARMOR) surveillance study, which monitors the potency of a variety of common antibiotics against ocular pathogens, and the first report of susceptibility data for ocular isolates collected across Canada;
  • The associations of neovascular Age-related Macular Degeneration (AMD) with omega-3 serum and red-blood cell membranes (RBCM) n-3 PUFAs;
  • The anti-inflammatory effects of Loteprednol etabonate (LE) with other ocular glucocorticoid (GCs) in human ocular and inflammatory cell types;
  • The image stability and predicted logMAR retinal image resolution of one investigational (samfilcon A) and three commercially available contact lenses as they dehydrate with time;
  • An analysis of a novel silicone hydrogel lens material, samfilcon A, at various curing time points to confirm a dual phase polymerization achieving the targeted physical properties.
  • The effect of latanoprostene bunod (LBN) on primary human trabecular meshwork cell (HTMC) contractility and underlying signaling pathways, to assess whether LBN may mediate this additional IOP lowering via the conventional outflow pathway;
  • Two LBN clinical studies evaluating 24 hour IOP control (CONSTELLATION and KRONUS) are also being presented.

The following schedule includes all Bausch + Lomb-supported poster presentations that will be featured during the meeting:

Pharmacology and Clinical Studies
546 - A0182. “NO-induced Regulation of Primary Human Trabecular Meshwork Cell Contractility by Latanoprostene Bunod.” Cavet, Megan E.; Vollmer, Thomas R.; Harrington, Karen; VanDerMeid, Karl; Richardson, Mary. [Sunday, May 4, 1:30 – 3:15 p.m., Exhibit/Poster Hall, Pharmacology and Clinical Studies].

548 - A0184. “Efficacy of Latanoprostene Bunod Ophthalmic Solution, 0.024%, in Lowering Intraocular Pressure Over 24-Hours in Normal Japanese Subjects (KRONUS).” Araie, Makoto; Ong, Tuyen; Scassellati-Sforzolini, Baldo; Ngumah, Quintus; Vittitow, Jason L.; Weinreb, Robert N. [Sunday, May 4, 1:30 – 3:15 p.m., Exhibit/Poster Hall, Pharmacology and Clinical Studies].

Ocular Surface
1489 - C0128. “Antibacterial Susceptibility of Coagulase Negative Staph Before and After Prophylactic Use of Besifloxacin and Moxifloxacin.”  Bucci, Frank A.; Sanfilippo, Christine M.; DeCory, Heleen H.; Amico, Loretta; Evans, Ruth E.; Comstock, Timothy L. [Monday, May 5, 8:30 – 10:15 a.m., Exhibit/Poster Hall, Ocular Surface Health and Disease].

Retinal Diseases
650 - C0060. “Circulating Omega-3 Fatty Acids and Neovascular Age-related Macular Degeneration.” Merle, Benedicte; Benlian, Pascale; Puche, Nathalie; Bassols, Ana; DelCourt, Cecile; Souied, Eric H. [Sunday, May 4, 1:30 – 3:15 p.m., Exhibit/Poster Hall, Retinal diseases in the aged eye].

Glaucoma
SIG – Organizer.” Emmanuel S. Buys; W Daniel Stamer; Emmanuel S. Buys; W Daniel Stamer; Louis R. Pasquale; Paul L.Kaufman; Jason L. Vittitow. [Sunday, May 4, 1:30 – 3 p.m., S 310A-D, New insights into the role of nitric oxide signaling in glaucoma - SIG].

Development of a Nitric Oxide-Donating Prostaglandin for the Treatment of Glaucoma.” Jason L. Vittitow. [Sunday, May 4, 1:30 – 3 p.m., S 310A-D, New insights into the role of nitric oxide signaling in glaucoma - SIG].

Ocular Infection
6297 - B0248. “In vitro Antibiotic Susceptibility Profile of Ocular Pathogens - Results from the First ARMOR Canada Surveillance Study.” Blondeau, Joseph M.; Sanfilippo, Christine M.; Morris, Timothy W.; Deane, Jennifer; Sahm, Daniel F. [Tuesday, May 6, 8:30 – 10:15 a.m., Exhibit/Poster Hall SA, Clinical and Translational Studies in Ocular Infection and Immunity].

Dry Eye Disease
3690 - A0204. “Objective Evaluation of Ocular Surface Lubricants in Dry Eye Patients using Thermal Imaging.” Ranjini Kottaiyan; Holly B. Hindman; Geunyoung Yoon; Stephen Davio; James Zavislan; James Aquavella. [Tuesday, May 6, 3:45 – 5:30 p.m., Exhibit/Poster, Hall SA, Dry Eye Disease #2].

Antimicrobials
5790 - B0215. “Besifloxacin Ophthalmic Suspension, 0.6% Compared with Gatifloxacin Ophthalmic Solution, 0.3% for the Treatment of Bacterial Conjunctivitis in Neonatal Patients.” Ong, Tuyen; Allaire, Catherine; Morris, Timothy W.; Sforzolini, Baldo [Thursday, May 8, 8:30 – 10:15 a.m., Exhibit/Poster Hall SA, Antimicrobials].

Corneal Infection and Inflammation
6281 - B0200. “Antibiotic Resistance Profile of Ocular Pathogens – An Update from the 2013 US ARMOR Surveillance Study.” Sanfilippo, Christine M; Morris, Timothy W.; Deane, Jennifer; Draghi, Deborah C.; Sahm, Daniel F. [Thursday, May 8, Noon – 1:45 p.m., Exhibit/Poster Hall SA, Corneal Infection and Inflammation].

Cornea/Ocular surface
6297 - B0248. “Anti-inflammatory Effects of the Glucocorticoid Loteprednol Etabonate in Human Ocular and Inflammatory Cells.” Vollmer, Thomas R.; Cavet, Megan E.; Harrington, Karen L.; Volhejn, Stepan M.; Richardson, Mary. [Thursday, May 8, Noon – 1:45 p.m., Exhibit/Poster Hall SA, Cornea/ocular surface / ocular inflammation: pharmacology].

Contact Lenses
864. “Surface Characterization of the Interaction Between Peroxide Neutralizing Disks and Platinum
Modulating Compounds
.” Kimberly A. Millard; Suzanne F. Groemminger; Andrew Hoteling; Daniel Hook; Katarzyna Wygladacz. [Sunday, May 4, 4:30 – 4:45 p.m., S 331A-D, Contact Lens].

4636 - A0261. “Predicted logMAR Image Resolution During Dehydration for Silicone Hydrogel Contact Lenses.” Paul Ludington; Kristen Hovinga; Mohinder Merchea. [Wednesday, May 7, 11 a.m. – 12:45 p.m., Exhibit/Poster Hall SA, Contact Lens].

4640 - A0265. “Surface and Bulk Properties of a Novel Inherently Wettable Silicone Hydrogel Material.” Katarzyna A. Wygladacz; Anthony Taddei; Daniel Hook. [Wednesday, May 7, 11 a.m. – 12:45 p.m., Exhibit/Poster Hall SA, Contact Lens].

4645 - A0270. “Influence of Buffering Systems on Acanthamoeba Encystment Following Prolonged Storage with Experimental Formulations and a Novel Hydrogen Peroxide-based Disinfecting Solution.” Shawn C. Lynch; Christopher Kovacs; Kimberly A. Millard; Suzanne F. Groemminger; Timothy W. Morris. [Wednesday, May 7, 11 a.m. – 12:45 p.m., Exhibit/Poster Hall SA, Contact Lens].

4648 - A0273. “Optimizing Physical Properties of a Silicone Hydrogel Material with Dual Phase Polymerization Processing.” Andrew Hoteling; Daniel Hook; Ivan Nunez; Joseph McGee; Joseph Hoff. [Wednesday, May 7, 11 a.m. – 12:45 p.m., Exhibit/Poster Hall SA, Contact Lens].

4650 - A0275. “Novel Ethylenically Unsaturated Polycarbosiloxane Monomers for Next Generation Silicone Hydrogel Contact Lenses.” Alok K. Awasthi. [Wednesday, May 7, 11 a.m. – 12:45 p.m., Exhibit/Poster Hall SA, Contact Lens].

4654 - A0279. "Comparing the Static and Kinetic Friction of Unworn and Worn Silicone Hydrogel Contact Lenses.” Daniel Hook; Sandra Taft; Robert Steffen; Mohinder M. Merchea. [Wednesday, May 7, 11 a.m. – 12:45 p.m., Exhibit/Poster Hall SA, Contact Lens].

6046 - A0123. “Biocidal Efficacy of Hydrogen Peroxide Solutions against Clinical Isolates of Fungal
Pathogens
.” Brien C. David; Deborah McGrath; Denise Callahan; Juliann Mason; Julie Bair; Tiffany Hilfiker; Patricia A.Walsh. [Thursday, May 8, Noon – 1:45 p.m., Exhibit/Poster Hall SA, Contact Lens].

6052 - A0129. “Simultaneous Determination of the Rate of Disinfection and Peroxide Neutralization of a Novel Hydrogen Peroxide Disinfecting System.” Deborah McGrath; Kimberly A. Millard; Damien Cordero; Timothy W. Morris. [Thursday, May 8, Noon – 1:45 p.m., Exhibit/Poster Hall SA, Contact Lens].

6063 - A0140. “Comparative Surface Smoothness Durability of a Novel Silicone Hydrogel Material.” Mohinder M. Merchea; Katarzyna A. Wygladacz; Daniel Hook. [Thursday, May 8, Noon – 1:45 p.m., Exhibit/Poster Hall SA, Contact Lens].

6067 - A0144. “Atomic Force Microscopy and Coefficient of Friction Analysis of Unworn and Worn Soft
Contact Lenses.
” Jeffery Schafer; Robert Steffen; Katarzyna A. Wygladacz; Charles Lusignan; Daniel Hook; Kristin Simoncelli. [Thursday, May 8, Noon – 1:45 p.m., Exhibit/Poster Hall SA, Contact Lens].

Bausch + Lomb is also sponsoring an oral presentation that will be included in the glaucoma pharmacology and clinical studies section as follows:

Glaucoma Pharmacology and Clinical Studies
3549. “Efficacy of Latanoprostene Bunod Ophthalmic Solution 0.024% Compared with Timolol Maleate Ophthalmic Solution 0.5% in Lowering IOP over 24 hours in Subjects With Open Angle Glaucoma or Ocular Hypertension (CONSTELLATION).” Liu, John H.; Vittitow, Jason L.; Ngumah, Quintus; Weinreb, Robert N. [Tuesday, May 6, 3:45 – 5:30 p.m., Exhibit/Poster Hall SA, Glaucoma Pharmacology and Clinical Studies].

Important Risk Information about LOTEMAX Gel

LOTEMAX Gel Indication
LOTEMAX® GEL is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.

Contraindications

  • LOTEMAX® Gel is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

Warnings and Precautions

  • Intraocular pressure (IOP) increase - Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored.
  • Cataracts - Use of corticosteroids may result in posterior subcapsular cataract formation.
  • Delayed healing - Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation and occurrence of perforations in those with diseases causing corneal and scleral thinning. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification.
  • Bacterial infections - Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infection. In acute purulent conditions, steroids may mask infection or enhance existing infections.
  • Viral infections – Use of corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and exacerbate the severity of many viral infections of the eye (including herpes simplex).
  • Fungal infections - Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. 
  • Contact lens wear - Patients should not wear contact lenses when using LOTEMAX Gel.
Intraocular pressure (IOP) increase - Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored.


Adverse Reactions

  • The most common ocular adverse drug reactions were anterior chamber inflammation (5 percent), eye pain (2 percent) and foreign body sensation (2 percent).

Please see LOTEMAX Gel full prescribing information here(155.2 KB, PDF).

BESIVANCE Indication
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.

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 reported in 2 percent of patients treated with BESIVANCE was conjunctival redness. Other adverse events reported in patients receiving BESIVANCE occurring in approximately 1-2 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 see BESIVANCE full prescribing information here(214.8 KB, PDF).

About Bausch + Lomb
Bausch + Lomb, a Valeant Pharmaceuticals International, Inc. company, is a leading global eye health organization that is solely focused on protecting, enhancing, and restoring people’s eyesight. Our core businesses include ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments. We develop, manufacture and market one of the most comprehensive product portfolios in our industry with products available in more than 100 countries.
 
Bausch + Lomb is a trademark of Bausch & Lomb Incorporated or its affiliates.
All other brand/product names are trademarks of their respective owners.
© Bausch & Lomb Incorporated

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News Media Contacts
Tad Heitmann
BioComm Network on behalf of Bausch + Lomb
(714) 273-2937
theitmann@BioCommNetwork.com

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