December 2008

CONTACT LENS MICROBIOLOGY WORKSHOP

A public workshop entitled: “Microbiological Testing for Contact Lens Care Products” will be held on January 22- 23, 2009, from 8:00 a.m. to 5:00 p.m. This workshop is being held with the American Academy of Ophthalmology, the American Academy of Optometry, the American Optometric Association, and the Contact Lens Association of Ophthalmologists as co-sponsors with the FDA.

 

The purpose of the workshop is to discuss test methods for evaluating the anti-microbial activity of contact lens care products with the goal to reach consensus on critical test method parameters for evaluating the activity of contact lens care products against Acanthamoeba. These parameters include organism species and strain, trophozoite culture and cyst production, microbial challenge level, and assay method for survivors. The workshop will also present and discuss critical elements for new or modified disinfection efficacy test methods that simulate “real world” consumer use conditions. These elements include contact lens and lens case uptake of preservative and other solution ingredients, solution evaporation, minimal consumer compliance, biofilm formation, and clinical isolates as challenge organisms. The workshop will be held at the Food and Drug Administration, White Oak Conference Center, 10903 New Hampshire Ave., Building 2 (Central Shared Use Building), Silver Spring, Maryland 20993.

Anyone interested in attending this workshop must register online at the following Web site: www.jcahpo.org/clmw by January 8, 2009. There will be no onsite registration. There is a registration fee of $250 for this workshop. Early registration is recommended because seating is limited. Persons without Internet access may contact Ms. Janice Prestwood for help in completing the registration form at (800) 284-3937 ext. 229, (651) 731-7229 (direct), or FAX (651) 731-0410.

All required information regarding this workshop is available on the registration Web site noted above. Additional information may be obtained by contacting:

Daryl L. Kaufman, MA
Center for Devices and Radiological Health
U.S. Food and Drug Administration
9200 Corporate Blvd (HFZ-460)
Rockville, Maryland 20850
Phone: (240) 276-4200, FAX: (240) 276-4234
e-mail: Daryl.Kaufman@fda.hhs.gov 

Marc Robboy, OD
Center for Devices and Radiological Health
U.S. Food and Drug Administration
9200 Corporate Blvd (HFZ-460)
Rockville, Maryland 20850
Phone: (240) 276-4200, FAX: (240) 276-4234,
e-mail: Marc.Robboy@fda.hhs.gov

INTERNATIONAL CONTACT LENS SUMMIT
Mark your calendar now for the contact lens event of the year. The International Contact Lens Summit, incorporating the CLAO Annual Meeting, will be held September 24 – 26, 2009, at the Hyatt Regency Hotel in Montreal, Canada. Many International speakers will be presenting cutting edge information in the field of contact lenses and anterior segment science. Exciting social events are currently being planned for Montreal, a city sometimes referred to as the “Paris of North America.” Additional information on the meeting and other meeting specifics will be updated on the CLAO home page at www.clao.org as it becomes available. You may also contact the CLAO home office via phone (877) 501-3937, fax (651) 731-0410 or email (eyes@clao.org) with any questions.

 

 

PRODUCT/INDUSTRY NEWS

Information in this section has been provided to CLAO by press releases and other means. CLAO does not warranty its accuracy nor does notice of a product in this section constitute an endorsement by CLAO. 

The American Academy of Ophthalmology (AAO) announced on November 21, 2008, that David W. Parke II, MD, will take the helm in April 2009, as the Academy’s new executive vice president (EVP) and chief executive officer (CEO). He will succeed retiring EVP/CEO H. Dunbar Hoskins Jr., MD, who has led the Academy since 1993. Dr. Parke has served on the Academy’s Board of Trustees since 2000, and is the 2008 Academy president. Dr. Parke is the president and CEO of the Dean McGee Eye Institute in Oklahoma City, one of the nation's largest nonprofit facilities devoted solely to research, clinical care, and education in ophthalmology and vision science. Dr. Parke is also a professor and chair of the Department of Ophthalmology at the University of Oklahoma, College of Medicine.

Bausch and Lomb announced on December 3, 2008, that its Board of Directors has elected Susan A. Roberts as a corporate vice president. She is the company’s chief compliance officer, having been named to this post in 2006, and heads the global pharmacovigilance and safety surveillance groups. Ms. Roberts joined Bausch & Lomb in 1995 after several years in private practice as a trial lawyer at Harter, Secrest & Emery. She then held positions of increasing responsibility in the Bausch & Lomb Law department, including serving as vice president and assistant general counsel. Ms. Roberts holds a J.D. cum laude from the Albany Law School of Union University and a Bachelor’s degree from Binghamton University. In further news, the company announced on December 5, 2008, that the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously to recommend approval of Bausch & Lomb’s besifloxacin ophthalmic suspension, 0.6%, for the treatment of bacterial conjunctivitis. The company has developed this broad-spectrum, anti-infective drop specifically for ophthalmic use. All new chemical entities such as besifloxacin, a fluoroquinolone, must be reviewed by an FDA advisory committee as part of the approvals review process for new drug applications.

Bochner Eye Institute, Toronto, Canada, reports that a remarkable new procedure for treatment of keratoconus has come to North America via Europe, i.e., C3-R or cross-linking with Riboflavin. There is now over a 10-year history of C3-R in Europe, with numerous scientific papers in peer-reviewed literature. Although still under the investigational use in the United States, it is anticipated that the procedure will be clinically available in three to four years in the U.S. At present, the procedure is widely considered to be the standard of care for keratoconus patients in Europe and Canada. Bochner Eye Institute reports that they have been fortunate to be the first in Canada to perform this procedure since January 2008. For a report from Bochner on their experience with the procedure, please contact their office via phone at (416) 966 – 3333. 

CooperVision announced on December 1, 2008, that its Biofinity® silicone hydrogel contact lenses have been approved by the FDA for extended wear in the United States, providing indication of possible overnight wear for up to six nights and seven days. The extended-wear approval is effective immediately, and applies to all Biofinity monthly replacement lenses currently available. Designed with Aquaform™ technology, Biofinity monthly replacement lenses are made with a lens material that offers high water content, a low modulus, and high oxygen transmissibility. Practitioners can now fit their patients with Biofinity, used on an extended wear basis, using lenses from their existing Biofinity fitting sets eliminating the need for new trial lenses. Biofinity lenses are manufactured with a third-generation silicone hydrogel material, comfilcon A. The water content of Biofinity is 48 percent, Dk is 128, and Dk/t is 160. The lens also features a base curve of 8.6mm, a diameter of 14.0mm, and is available in a sphere power range of +8.00D to -12.00D.

 

 

MARK YOUR CALENDAR

  • Asia Pacific Academy of Ophthalmology will be holding its annual meeting on May 16-19, 2009, in Bali. Next year’s meeting will be held jointly with the American Academy of Ophthalmology. For more information: http://www.apao2009bali.org/index00_1.shtml
  • International Contact Lens Summit, incorporating the CLAO Annual Meeting, will be held September 24 – 26, 2009 in Montreal, Canada

 

CLAO “DID YOU KNOW?”

When fitting soft bifocal contact lenses, it is recommended to do so under normal room illumination and to over-refract monocularly with both eyes open.