FDA Takes Action About Impact-Resistant Lenses
FDA Takes Action About Impact-Resistant Lenses
The U.S. Food and Drug Administration initiated an updated FDA Import Alert in late August. The Import Alert 86-07 Detention Without Physical Examination of and Guidance for Impact-Resistant Lenses in Eyeglasses and Sunglasses (IA 86-07) includes a Red List of five firms that have been added since July 15, 2010.
Upon importation into United States Commerce, importers of sunglasses and eyeglasses must present to the FDA a certificate validating that the lenses were tested for impact resistance and passed those tests. According to FDA Import Alert 86-07, the agency independently started testing imported sunglasses and eyeglasses and found as many as 70 percent of certified impact-resistant lenses (in an extreme case) had invalid certificates.
If the FDA finds that the number of failing lenses in a shipment exceeds minimum standards, the FDA will refuse (or reject) the entire shipment and require the importer to deliver the shipment for destruction or exportation.
On Sept. 2, 2010, the FDA also released a revised version of its guidance titled "Impact-Resistant Lenses: Questions and Answers." This guidance document answers manufacturer, importer, and consumer questions on impact-resistant lenses, including questions on test procedures, lens testing apparatus, record maintenance, and exemptions to testing. It also contains more detailed and updated discussions of (1) lens blanks, (2) semi-finished, finished, and plano lenses, and (3) import entry inspections.
SynergEyes Gets FDA Nod for New Technology
The U.S. Food and Drug Administration approved SynergEyes, Inc.'s new hybrid platform for use in correcting hyperopic, myopic, and astigmatic refractive error, including presbyopia, in aphakic and non-aphakic, non-diseased eyes. SynergEyes will market the new hybrid technology as two contact lens products: Duette hybrid contact lenses for astigmatism and Duette Multifocal for presbyopia. The Duette hybrid contact lens products feature a new SynergEyes-developed GP material, MaxVu, and a proprietary Flex2O silicone hydrogel skirt. The lenses are indicated for daily wear for correction of up to ±20.00D in eyes with astigmatism up to +6.00D.
Duette hybrid contact lenses for astigmatism are currently available in limited release in select practices in the United States. A nationwide launch is planned for early 2011. In addition, Duette Multifocal will be available in limited release in early 2011.
TearLab, AMO Form Agreement
TearLab Corporation and Abbott Medical Optics Inc.'s Canadian subsidiary, AMO Canada, have entered into a cooperative marketing agreement. Under the agreement, AMO Canada's sales force will directly sell the TearLab Osmolarity System in Canada while TearLab will help promote AMO Canada's products for the relief of dry eye symptoms, including Blink Moisturizing Eye Drops. Financial terms were not disclosed.
The TearLab Osmolarity System is intended to measure the osmolarity of human tears to aid in the diagnosis of dry eye disease in conjunction with other methods of clinical evaluation. Using a lab-on-a-chip approach, the TearLab System requires less than 50 nL (nanoliters) of tear fluid and displays quantitative osmolarity results in less than 30 seconds. By requiring such a small amount of tears, the TearLab System eliminates the challenges that previously prevented point-of-care osmolarity testing. In addition, it is simple enough to be operated by a technician, according to TearLab.
Limited Voluntary Recall of TruEye Overseas
In late August, Johnson & Johnson Vision Care, Inc. initiated a voluntary recall of select lots of 1-Day Acuvue TruEye Brand Contact Lenses (narafilcon A) manufactured in Ireland and distributed in Japan as well as in several countries within Asia and Europe. No other markets are affected including the United States, which markets a different version of 1-Day Acuvue TruEye made with narafilcon B.
J&J initiated the voluntary recall because it received a limited number of customer complaints in Japan associated with the affected lots. Some of the reported complaints described an unusual stinging or pain upon application. Most events involved one eye of the patient. According to J&J, long-term health consequences arising from this situation would be unlikely.
Upon investigation, the company determined that there was an isolated issue in one portion of the lens rinsing process on a particular manufacturing line in a select number of lots. No other lots of this product or of any other Acuvue product are affected.
The company suspended shipment of the affected lots still in its control and has implemented corrective actions to ensure that products meet the company's carefully controlled standards.
|■ Paragon Vision Sciences now offers an improved packaging system for Paragon CRT SureFit, which comes with an enhanced 90-day warranty. The lenses are clearly identified, and the inside of the CRT SureFit three-pack box shows an oversized fluorescein pattern of a perfectly fit CRT lens and simplified fitting instructions along with a reminder to return the two non-dispensed lenses back to Paragon in a prepaid envelope within 90 days. Visit www.paragoncrt.com/surefit.|
■ Menicon Co., Ltd. has appointed Chew Hwee Yong as chief of Special Projects at the company's head office in Nagoya, Japan. Chew will be responsible for updating and expanding Menicon's internal processes as well as external relations to support Menicon's globalization.
■ Bausch + Lomb has named Daniel M. Wechsler as corporate vice president and global president of its Pharmaceuticals business. Mr. Wechsler was most recently head of U.S. Strategy, Commercial Model Innovation and Business Development for Merck & Co. B+L has also named Michael J. Rowe as corporate vice president, Human Resources. Mr. Rowe was most recently a senior consultant with Proteus International, Inc.
■ VSP Vision Care and Vistakon have announced an enhanced additional rebate program to VSP members that began on Oct. 1. Members who purchase an annual supply of Acuvue Brand contact lenses from one of VSP's 27,000 network providers will receive an additional $25 rebate on top of the current national rebate program offered by Vistakon.
■ At the Association for Research and Vision in Ophthalmology annual meeting, Alcon presented data on a new wetting agent—a synthetic block copolymer that uses proprietary polymer chemistry, EOBO, poly (oxyethylene)-poly (oxybutylene). The poster presentation indicated that a test solution containing EOBO reduced the surface and bulk hydrophobicity and improved the hydrophilic properties of silicone hydrogels as compared to a saline solution control. Alcon is developing this technology specifically for silicone hydrogels for possible future use in its lens care product line.
■ Ista Pharmaceuticals has initiated a Phase 3 clinical program of its proprietary formulation of Remura (bromfenac ophthalmic solution for dry eye) for alleviating the signs and symptoms of dry eye disease. The Phase 3 efficacy studies are being conducted under a Special Protocol Assessment agreed upon with the U.S. Food and Drug Administration. Ista plans to assess the safety and efficacy of Remura by conducting four randomized, doublemasked, placebo-controlled Phase 3 studies.
■ Can-Fite BioPharma, a biotechnology company traded on the Tel Aviv Stock Exchange, has opened an investigational New Drug application with the U.S. Food and Drug Administration for a Phase 3 study of its lead drug, CF101, in patients who have moderate to severe dry eye syndrome. In an earlier Phase 2 study in which CF101 was taken orally as a monotherapy for 12 weeks, a statistically significant benefit in the clearing of fluorescein staining in the nasal, temporal, pupillary, and inferior parts of the cornea was documented.
|Vistakon Announces Personnel Changes|
|■ Vistakon has announced appointments for professional affairs and new products. Giovanna E. Olivares, OD, FAAO, in now director, Professional Education, and will be responsible for developing strategies for the implementation of the company's professional educational programs across a broad spectrum of groups, including students, practitioners, Professional Affairs consultants, and Vistakon sales and marketing organizations. In her new role, she will report to Colleen Riley, OD, MS, FAAO, Dipl CL, vice president of Professional Development. Dr. Olivares joined Vistakon in 2004 as manager of the R&D Design Clinical Research Group, where she led a multidisciplinary group overseeing the clinical development of new contact lens products.|
Carol Lakkis, BScOptom, PhD, clinical research fellow, Contact Lens Products, is now responsible for research and development of new products. Dr. Lakkis joins Vistakon from Clinical Vision Research Australia at the Australia College of Optometry where she served as research director, overseeing clinical and laboratory-based projects. Prior, Dr. Lakkis held several positions in the Department of Optometry and Vision Sciences at the University of Melbourne as well as positions at the School of Optometry at the University of California at Berkeley. She will report to Dave Turner, PhD, director, Materials Research & Development.
|■ B+L Launches Cataract Education Site|
Bausch + Lomb has launched the site www.cataracteducation.com to educate the estimated 20 million baby boomers and seniors who are currently living with cataracts in the United States. The site contains information on what causes cataracts, describes how they are treated, and emphasizes the importance of regularly visiting your eye doctor. Actress Florence Henderson will also be featured on the site, sharing her experiences with B+L's Crystalens Intraocular Lens.
■ Ciba's Academy for Eyecare Excellence Expands Offerings
The Ciba Vision Academy for Eyecare Excellence has added 16 new online learning modules covering both advanced and basic topics, ranging from multifocal soft lens fitting to ocular anatomy. Some modules are designated for eyecare practitioners while others are for staff members. A test taken at the end of each module is scored instantly, after which users can print a certificate of completion. Visit www.cibavisionacademy.com/us.
Contact Lens Spectrum, Issue: October 2010