CIBA Recalls Some O2Optix
CIBA Vision is conducting a voluntary trade-level (not consumer) recall of select lots of spherical O2Optix (lotrafilcon B) contact lenses, distributed primarily in the United States and to a lesser degree in other countries, excluding Japan. No other CIBA Vision lenses are involved in this recall.
CIBA is recalling the lots because the company identified that some lenses in the lots may fall below its standard for ion permeability, which is a measure of the ability of sodium ions to permeate through a contact lens material and correlates with lens movement on the eye. The potential medical safety risk to consumers posed by lenses with reduced ion permeability includes discomfort, foreign body irritation and superficial localized corneal staining. A medical assessment, confirmed by external experts, estimates that the possibility of occurrence of these findings is moderate and that the probability of serious adverse events from wearing the lenses is remote. No serious adverse events have been attributed to this issue worldwide, and only seven non-serious product complaints may be related.
The affected O2Optix lenses were distributed between September 2006 and December 2006, with lot numbers of 6644001 to 6721262 with expiration dates starting from 2011/09 to 2011/11, as well as lot numbers 6626127, 6636101, 6637017, 6637019, 6637103, 6640120, 6640124, 6642109, 6642119 and 6643080, all with expiration dating of 2011/08.
CIBA has already implemented manufacturing process improvements and addressed the ion permeability issue. However, the company anticipates that product availability will be affected, with significant O2Optix supply constraints and backorders expected into the second quarter with increasing improvements through mid-year.
CooperVision Launches New Daily Disposable
CooperVision has launched ClearSight 1-Day, a new line of daily disposable soft contact lenses. The new lens is now available from CooperVision and its authorized distributors.
The manufacturer says that ClearSight 1-Day, made of a 52-percent water content material, features a thinner lens design that minimizes lid interaction to help ensure comfortable lens wear.
ClearSight 1-Day lenses are also specially designed for easier handling. CooperVision says that the ergonomic blister packaging is designed for easy opening, and each lens has a light blue visibility tint to help patients see the lenses more clearly when they're out of the eye.
ClearSight 1-Day lenses also have a UV blocker to help protect eyes from ultraviolet rays.
CLMA 2007 Committee Chairs
Janice Schramm, president of the Contact Lens Manufacturers Association, recently appointed the following CLMA 2007 Committee Chairs:
Associate Members Committee, Jim Drain, DAC International, Inc.
Awards Committee, Daniel Bell, Corneal Design Corporation
2007 Convention Committee, David Bland, Bausch & Lomb, the Boston Group
Government Affairs Committee, Daniel Bell
GP Lens Committee, Rob Breece, OD, MedLens Innovations, Inc.
Internal Affairs/Finance Committee, Al Vaske, Lens Dynamics, Inc.
International Committee, Bill Hoffman, The Lagado Corporation
Member Services Committee & Membership Committee, Ken Leonhard, Quality Contact Lens, Inc. and Chris Pantle, DAC International, Inc.
Nominating Committee, Daniel Bell
2007 Annual Meeting Program Committee, Jan Svochak, Tru-Form Optics, Inc.
Public & Professional Information Committee, Naomi "Jo" Svochak, Tru-Form Optics, Inc.
Soft Lens Manufacturing & Distribution Committee, John Walfoort, Soderberg, a Walman Optical Company
Technical Affairs Committee, Arch Holcomb, Westlens.
B&L Considers Presbyopia Treatment, Changes Management
Bausch & Lomb recently made an equity investment in and secured an exclusive option to purchase AcuFocus, Inc., a privately held company located in Irvine, Calif. The AcuFocus ACI 7000 corneal inlay is designed to treat presbyopia in all patients, including those who have had cataract surgery.
The corneal inlay is implanted in the cornea under a LASIK flap in an outpatient procedure. The device incorporates technology that increases the patient's depth of field, thereby improving near vision. The procedure doesn't involve tissue removal and doesn't permanently alter the cornea, so pre-implant vision can be restored if the inlay is removed. Recent studies have demonstrated that the ACI 7000 improves near vision in emmetropes as well as in those who've undergone LASIK.
In other news, following the resignation announcement of Paul G. Howes from his position as senior vice president and presidentAmericas region, B&L announced that Gary M. Phillips, MD, will head U.S. Pharmaceutical and Surgical Businesses, Angela J. Panzarella assumes additional responsibility for Commercial Operations in Canada and Latin America, and Robert J. Moore continues as head of U.S. Vision Care Businesses.
Children's Vision Bill Introduced
The Vision Care for Kids Act of 2007, HR 507, was introduced to the House of Representatives and the Senate under the sponsorship of U.S. Sens. Christopher "Kit" Bond (R-MO) and Christopher Dodd (D-CT) and U.S. Reps. Eliot Engel (D-NY), Vito Fossella (R-NY), Gene Green (D-TX), Bill Pascrell (D-NJ), Ileana Ros-Lehtinen (R-FL) and John Sullivan (R-OK).
The legislation is supported and was developed by an alliance of the American Academy of Ophthalmology, the American Association for Pediatric Ophthalmology and Strabismus, the American Optometric Association, Prevent Blindness America and the Vision Council of America. It focuses on providing children with the follow-up care they need after being identified with a potential vision problem by a comprehensive eye exam or vision screening.
Identical versions of the bill were introduced concurrently in both the House and the Senate to help expedite the legislative process and ensure that the bill's intent remains uncompromised.
The Centers for Disease Control and Prevention report that only one in three children in America receives eyecare services before age 6, despite the fact that one in four preschoolers has a vision problem.
AMO Acquires Two Companies
- Advanced Medical Optics recently acquired WaveFront Sciences, Inc., a leading provider of proprietary wavefront diagnostic systems for refractive surgery and medical research. WaveFront Sciences designs and manufactures the industry's highest resolution Shack-Hartmann-based aberrometer, which measures the total refractive error and wavefront aberrations of the human eye as part of the wavefront-guided custom laser vision correction procedures. AMO acquired WaveFront Sciences for approximately $20 million, including a $14 million cash payment at closing and an agreement to make a total of $6 million in future cash payments contingent on achievement of certain milestones over the next three years.
AMO and IntraLase Corp. have also entered into a definitive agreement for AMO to acquire IntraLase for approximately $808 million in cash. Following the receipt of fairness options from their respective financial advisors, AMO will pay $25 in cash per share of IntraLase stock and the individually determined cash value per share of outstanding stock options. AMO expects the transaction to be finalized in the second quarter of 2007. IntraLase believes that the acquisition will help to advance the company's femtosecond laser technology in a coordinated way, both developmentally and commercially.
- Advanced Vision Technologies has received authorization to distribute the Paragon CRT product line. AVT will focus on providing educational and practice management resources for corneal reshaping.
- Bausch & Lomb reports that a recent nationwide clinical evaluation of 107 patients fit with Acuvue Advance for Astigmatism (Vistakon) found that 74.5 percent of eyes achieved 20/20 or better visual acuity at the outset of the study. However, when refit with B&L PureVision Toric lenses, the number of eyes achieving 20/20 or better visual acuity increased to 85.2 percent.
- UltraVision has concluded an agreement to acquire Alan Williams Contact Lens Ltd. The transition of the business was set to be complete by Feb. 1, 2007.
- The U.S. Food and Drug Administration issued an approvable letter to Allergan for Combigan (brimonidine tartrate/timolol maleate ophthalmic 0.2%/0.5%) for reducing elevated IOP in patients who have glaucoma or ocular hypertension. The letter outlines the remaining conditions Allergan must fulfill to obtain FDA final marketing approval. Combigan is already approved and marketed in Europe, Canada, Brazil and Australia.
- ArGentis, LLC, a Memphis-based specialty biopharmaceutical company, has licensed a second treatment for dry eye syndrome developed by researchers at the Southern College of Optometry. The licensed application covers the use of transdermal progesterone in treating dry eye.
- Johnson & Johnson announced the closing of its previously announced acquisition of Pfizer Consumer Healthcare. With the acquisition, J&J's Consumer group portfolio now features Visine products as well as Listerine oral care products, the Nicorette line of smoking cessation treatments and Sudafed cold, flu and allergy products.
- Bausch & Lomb recently purchased Alimera Sciences' OTC allergy franchise, including Alaway (ketotifen fumarate ophthalmic solution 0.025%), which was recently approved by the U.S. Food and Drug Administration. Alaway is an antihistamine indicated for up to 12 hours of temporary relief for itchy eyes due to ragweed, pollen, grass, animal hair and dander. B&L says Alaway contains the same active ingredient and strength and is shown to be therapeutically equivalent to Zaditor (Novartis).
- Ista Pharmaceuticals, Inc. has submitted an Investigational New Drug Application with the FDA for its eye drop formulation of bepotastine for treating allergic conjunctivitis. The formulation will go directly into Phase II/III clinical trials in the United States during the first quarter of 2007.
- Vision Service Plan and Alcon have made Fortune magazine's list of the "100 Best Companies to Work For," ranking 23rd and 65th respectively. This year is VSP's eighth year on the annual list and Alcon's ninth. The rankings are based primarily on anonymous employee responses to a survey that measures factors such as job satisfaction and camaraderie, combined with an evaluation of the companies' policies and culture.