B&L Receives FDA Approval of Besivance, Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis
Besivance is the first fluoroquinolone specifically developed for ophthalmic use and is the first and only ophthalmic fluoroquinolone with no previous systemic use, according to the company. It offers broad-spectrum antibacterial activity, including activity against the strains that are the most common causes of bacterial conjunctivitis.
"FDA approval of Besivance provides patients with an advanced therapy that can eradicate bacterial conjunctivitis at its source both safely and effectively," said Flemming Ornskov, MD, MPH, Corporate Vice President and Global President, Pharmaceuticals for B&L. "At Bausch & Lomb we are committed to developing innovative eye health products that help enhance patients' overall quality of life, and we are pleased to offer the medical community a new treatment option for this exceedingly common condition."
Besivance will be available by prescription in U.S. pharmacies in the second quarter of 2009 and will be promoted by both the B&L and Pfizer, Inc. sales forces. See full prescribing information for Besivance at: www.besivance.com.
BCLA 2009 Sets Attendance Record
A total of 45 companies exhibited at the meeting. Including those who only attended the exhibition, there were an estimated 1,500 visitors in total.
The BCLA Conference is a premier event for contact lens professionals in the UK and worldwide. This year, just over half of those registered (54%) were from overseas. Delegates came from 45 different countries, and the largest overseas delegations were from the USA (87) and Denmark (77), followed by Germany (39) and France (37).
At the Gala Dinner on May 30, outgoing President Dr. Sarah Janikoun handed her chain of office to William Thomas and 21 new BCLA Fellowships were awarded. Former BCLA President Nigel Burnett Hodd received honorary life membership of the BCLA in recognition of his significant contribution to the Association.
The 34th BCLA Clinical Conference and Exhibition will be held in Birmingham from May 27- 30, 2010. Keynote speakers will be David Anderson (UK), Suzi Fleiszig (USA) and Cristina Kenney (USA). Dr. Donald Korb (USA) will be the BCLA Medal Speaker and Dr. Panagiotis Kallinikos (Greece) will deliver the Irving Fatt Memorial Lecture. For more information on BCLA events and how to join, visit www.bcla.org.uk,
Free Online Symposia from the GPLI
The topics and hosts for upcoming symposia include:
June 9 - Corneal Reshaping for Children and Adults with Dr. John Rinehart and Dr. Jeff Walline; click here for June's case studies.
August 11 - GP Multifocal Correction with Dr. Rob Davis and Mr. Doug Benoit
October 13 - GP Correction of Keratoconus with Mr. Mike Ward and Dr. Ann Laurenzi
December 8 - GP Problem Solving with Dr. Pat Keech and Dr. Ken Maller
For more information on these symposia and other educational programs offered by the GPLI, visit www.gpli.info.
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PBA Announces Sixth Annual Investigator Awards
Investigator Award recipients for 2009 include Peter K. Kriz, MD, of Children's Hospital Boston, for his project entitled "Effectiveness of Protective Eyewear in Reducing Severe Eye Injuries in High School Field Hockey Players." The purpose of the study is to determine whether mandated protective eyewear effectively reduces the incidence of severe eye injuries within a select population of female hockey players.
Loretta B. Szczotka-Flynn, OD, MS and co-investigator Mahmoud Ghannoum, PhD, from Case Western Reserve University received an award for their research project entitled, "Prevention of Soft Contact Lens Associated Fusarium Biofilms." The study will utilize a model of soft contact lens biofilms to assess the efficacy of contact lens solutions against them and test mechanisms of their prevention.
Lastly, Steven M. Kymes, PhD, MHA, from Washington University in St. Louis, has received an award for his project "Development of a Model for Estimation of Longitudinal Changes in Mean Deviation in Patients with Primary Open Angle Glaucoma." This project will pool data from existing landmark glaucoma studies in an effort to construct a validated method of predicting the progression of glaucoma.
PBA has also declared June as Vision Research Awareness Month in an effort to educate the public on the critical role that ongoing research studies play in saving sight.
Contact Lens Spectrum June Case Report Now Online
Visit the Contact Lens Spectrum case report page after the first of every month to review details and images from the latest case study. You can also view case studies from previous months in the archive at the bottom of the page.
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FDA Advisory Committee to Review Bepreve from ISTA
On November 13, 2008, ISTA announced it had filed its NDA with the FDA for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis. The NDA filing includes data from ISTA's Phase III clinical studies with Bepreve which demonstrated highly statistically significant reductions in the primary endpoints of ocular itching, according to the company. As bepotastine is a new chemical entity in the U.S., ISTA expected an Advisory Committee would be convened for Bepreve. ISTA continues to expect a standard review of ten months and has been given a Prescription Drug User Fee Action (PDUFA) date of September 12, 2009.
Ascencion Named President, B&L Japan
Mr. Ascencion joined B&L in 2003 in the Corporate Audit Group. In 2004, he was named Director of Finance and Operations for the company's Mexican and Latin American Distributors businesses, and in 2006, he was appointed Controller of B&L Japan. Prior to joining B&L, he worked for Valeo Electrical Systems, Pricewaterhouse Coopers and Coopers & Lybrand.
Mr. Ascencion holds a degree in Strategic Administration from the Instituto Tecnologico de Estudios Monterrey (ITESM) and obtained his CPA from the National Autonomous University of Mexico.
Abstract: Corneal Recovery after Discontinuation of Overnight Orthokeratology
Orthokeratology significantly reduced manifest refraction (p<0.0001, Dunnett test) and significantly improved uncorrected visual acuity (UCVA) at 12 months after commencement of the procedure (p<0.0001). Asymmetry and higher-order irregularity components increased significantly (p<0.0001, p = 0.0032, respectively), and third- and fourth-order aberrations also increased significantly (p<0.0001). The treatment resulted in significant decreases in AULCSF (p = 0.0004). After discontinuing lens wear, all parameters, such as refraction, UCVA, asymmetry, higher-order irregularity, third-order aberration, fourth-order aberration and AULCSF, returned to the baseline level at one week.
The researchers concluded that this study confirmed that the effect of orthokeratology is completely reversible in light of optical quality of the eye and quality of vision, as well as refraction and visual acuity.
Hiraoka T, Okamoto C, Ishii Y, Okamoto F, Oshika T. Recovery of corneal irregular astigmatism, ocular higher-order aberrations, and contrast sensitivity after discontinuation of overnight orthokeratology. Br J Ophthalmol 2009;93:203-8.
Editor's Commentary: A Successful and Stimulating BCLA
Jason J. Nichols, OD, MPH, PhD, FAAO
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