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NEWS SPECTRUM
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 president—Americas 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
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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.
Industry Briefs
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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.
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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.
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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.
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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.
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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.
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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.
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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).
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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.
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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.
Contact Lens Spectrum, Issue: February 2007