Acuvue Oasys Approved for Therapeutic Use
Acuvue Oasys Approved for Therapeutic Use
The U.S. Food & Drug Administration has granted Acuvue Oasys (Vistakon) approval for therapeutic use as a bandage lens for a range of acute and chronic ocular conditions. The FDA said the lens also can provide vision correction during healing if required.
For this therapeutic indication, a clinical study of 43 subjects fit with Acuvue Oasys in therapeutic applications was conducted through a retrospective data collection. The cases demonstrated that using the lens was effective for pain management, barrier protection and for reducing corneal exposure and preventing recurrent damage. Researchers observed no safety issues in any of the reported cases.
FDA approval of Acuvue Oasys for therapeutic use as a bandage lens includes corneal protection in lid and corneal abnormalities such as entropion, trichiasis, tarsal scars and recurrent corneal erosion. In addition, the lens is indicated for protection where sutures or ocular structure malformation, degeneration or paralysis may result in the need to protect the cornea from exposure or repeated irritation.
Acuvue Oasys also gained approval for corneal pain relief and for use as a barrier during the healing process of epithelial defects such as chronic epithelial defects, corneal ulcer, neurotrophic and neuroparalytic keratitis and chemical burns.
The lens is furthermore now approved for postsurgical conditions where bandage lens use is indicated such as post-refractive surgery, lamellar grafts, corneal flaps and additional ocular surgical conditions.
Acuvue Oasys may also be used for structural stability and protection in piggyback lens fitting where the cornea and associated surfaces are too irregular to allow for corneal GP lenses to be fit.
|■ The $4.5 billion acquisition of Bausch & Lomb by private equity firm Warburg Pincus is complete. Ronald Zarrella, B&L's chairman and CEO, said the acquisition makes the company well-positioned to advance its leadership in the eyecare industry. B&L ceased trading on the New York Stock Exchange and was delisted.|
■ CIBA Vision has reported that in the third quarter of 2007, hydrogen peroxide lens care products accounted for 14 percent of the total disinfectant category retail sales, the highest share in the U.S. since the fourth quarter of 2005, with Clear Care leading the category at 11 percent dollar share of the disinfectant category. The company believes these results may reflect a change in eyecare professional recommendation of lens care products.
■ Advanced Medical Optics has added the name Oxysept to its U.S. UltraCare Formula hydrogen peroxide system. The formulation itself remains unchanged.
■ A recent study presented at the American Academy of Optometry by Tilia et al found that subjective overall lens comfort with silicone hydrogel lens daily wear increased as lens age increased, despite an increase in deposits and mucin balls on two-week modalities worn for longer than two weeks. The researchers advise practitioners to instruct patients to replace lenses as prescribed rather than relying on subjective judgement.
■ Also at the American Academy of Optometry, Jeff Walline, OD, PhD, presented the two-year data from the Corneal Reshaping and Yearly Observation of Near-sightedness (CRAYON) Study, which show that corneal reshaping contact lenses slow the axial growth of the eye and that the treatment effects continue to accumulate over two years.
■ Another study presented at the American Academy of Optometry studied patients who experienced dry eye symptoms with lens wear. The patients were refitted into an Acuvue Advance (Vistakon) lens in one eye and either Proclear (CooperVision) or Extreme H2O (Hydrogel Vision Corp.) in the other eye. Some patients used Refresh Tears (Allergan) as needed, the others used Restasis (Allergan) and no artificial tears. All of the lenses improved patients' dryness symptoms, but the Proclear and Extreme H2O lenses outperformed the Acuvue Advance lenses. Restasis use produced significantly more favorable outcomes on all measures across all lens types.
■ The FDA has approved Combigan (brimonidine tartrate/timolol maleate ophthalmic solution, Allergan) 0.2%/0.5%, an alpha adrenergic receptor agonist with a beta adrenergic receptor inhibitor, for the reduction of elevated intraocular pressure in patients who have glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP.
■ Bausch & Lomb's new Stellaris Vision Enhancement System marks a shift to sub-2mm microincision cataract surgery that's designed to speed vision recovery. The Stellaris is coupled with an array of specialized sub-2mm instruments — and outside of the United States, a microincision artificial intraocular lens — to allow for a 35 percent smaller incision that can enhance patient comfort and recovery.
■ Lantibio, Inc. and TRB Chemedica have entered a licensing agreement with a subsidiary of Alcon, Inc. for the U.S. development, marketing and manufacture of a dry eye syndrome product consisting of a TRB patented formulation containing sodium hyaluronate. Lantibio will conduct the development program and filing of the NDA, while Alcon will assume responsibility for subsequent marketing, sales and manufacturing for the U.S. market.
■ Vision Service Plan has provided an advertising grant to the American Optometric Association program InfantSEE. The grant provided funds for print ad placements in the July, September and November 2007 issues of Parents magazine as well as banner advertising on www.babyzone.com.
■ The American Medical Association will issue a new Current Procedural Terminology (CPT) code 87809 for "Infectious agent antigen detection by immunoassay with direct optical observation; Adenovirus" in 2008 that will cover the RPS Adeno Detector.
Younger Children Benefit From CL Wear
A new study shows that children as young as 8 can reap improvements in quality of life from contact lens wear.
Researchers reported the results of The Contact Lens in Pediatrics (CLIP) Study in the November issue of Eye & Contact Lens. The study, sponsored by Vistakon, compared the function and quality of life benefits of silicone hydrogel contact lenses (Acuvue Advance and Acuvue Advance for Astigmatism) among first-time wearers ages 8 to 12 and 13 to 17. Children and teens who participated in the study needed vision correction to see optimally.
Participants were asked how they felt about wearing contact lenses during sporting activities; 96 percent of children and 93 percent of teens said they "loved" or "liked" to wear contact lenses during sports. When asked about their sporting performance, 59 percent of children and 62 percent of teens felt their performance was "much better" or "better" while wearing contact lenses.
When asked which they liked better (or equally), 71 percent of children and 78 percent of teens said that they liked wearing contact lenses "a little better" or "a lot better" than glasses. Children said that they "always" or "usually" liked to wear their contact lenses 77 percent of the time, and teens reported the same 85 percent of the time. After three months of contact lens wear, each group wore their contact lenses on average 11 hours per day.
"The data show that children and teens perceive similar improvement in their quality of life when wearing contact lenses versus glasses," says Jeffrey J. Walline, OD, PhD, from the Ohio State University College of Optometry and study leader.
CIBA Appoints Executives
CIBA Vision recently announced that Henna Inam, currently president, Americas Region, has been appointed to the position of chief marketing and innovation officer. In this role she will work closely with the regional business as well as Research, Development and Engineering; and Global Supply Chain to accelerate the product innovation pipeline and execute upcoming product launches. She will also lead CIBA's overall global marketing efforts.
Concurrently, Francesco Balestrieri has been named president, North America Region. In this new role, CIBA's U.S. and Canadian country organizations, including sales and marketing, will report to him. Balestrieri has been with CIBA Vision for 14 years in various financial roles. He most recently served for two years as general manager for CIBA's Germany, Austria and Switzerland markets.
Inam and Balestrieri will transition into their new roles through the end of the year, and both will report to Andrea Saia, chief operating officer for CIBA Vision.
|Alcon Publishes Corporate Giving Report|
|Alcon Laboratories, Inc. has published its first annual Corporate Giving Summary titled A Legacy of Passion, which details Alcon's dedication to enhancing, protecting and restoring sight for people worldwide. Throughout the company's 60-year history, Alcon has supported programs, organizations and initiatives globally with donations of volunteer time, medical expertise, products, finances and additional resources.|
Globally, over the past three years Alcon has contributed $123 million in financial and product support to charitable organizations and programs for improving patient care, aiding global eye health, supporting U.S. communities and advancing eye health and education. The company also has a Global Medical Mission Program through which Alcon donates pharmaceutical products and surgical equipment to countries in need and supports more than 1,100 medical missions a year. Alcon was also an early and is a continued supporter of ORBIS and works with Caribbean Mercy ships.
Nationally, Alcon collaborates with eyecare physicians and domestic organizations to help prevent blindness and educate individuals about their eye health. On a local level, the report indicates that the company places strong emphasis on employee volunteerism and local-area giving in the areas of civic and community, health and human services, education and research, and arts and culture.
CLMA Presents Annual Awards
The Contact Lens Manufacturers Association held its 46th Annual CLMA Meeting and Exhibition from Nov. 8 to 10 in Albuquerque/Santa Fe, New Mexico. The meeting featured 25 exhibitors representing all facets of contact lens production, hands-on demonstrations, education sessions, new products and more.
The CLMA also held its annual awards dinner, where it honored the following awardees:
Honorary Recognition Award: Charley Creighton, in appreciation for a lifetime of dedication and service to the contact lens industry.
Industry Enhancement Award: Dr. Eef van der Worp, for unselfish dedication to the CLMA and the contact lens industry.
Trailblazer Award: Jim Drain, for outstanding achievement in product development to the enhancement of the contact lens industry.
GP Practitioner of the Year: Dr. Robert Grohe, for outstanding professional expertise in fitting GP contact lenses to the benefit of the contact lens industry and corneal health.
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|AAO Section on Cornea and Contact Lenses Awards|
|At the recent American Academy of Optometry annual meeting in Tampa, Fla., the Section on Cornea and Contact Lenses presented its annual awards.|
Oliver D. Schein, MD, MPH, received the Max Schapero Memorial Lecture Award and presented "The Epidemiology of Contact Lens-Related Microbial Keratitis: a 25 Year Perspective." This award honors those who have made significant contribution to the cornea and contact lens field by virtue of publications, lectures or research efforts.
The Founders Award honors an individual, group or company who has made an outstanding contribution to the clinical aspect of the art or science of contact lens fitting. This year's recipients included Perry Rosenthal, MD, and Vistakon for the 20th anniversary of Acuvue as the first disposable contact lens.
Oxygen and Lens Wear
A new study published in Cornea offers a new method of predicting corneal oxygenation during contact lens wear and shows that the higher the Dk/t of a lens, the closer it comes to fulfilling the oxygen needs of the cornea, particularly the peripheral cornea.
According to the study, a Finite Element Analysis (FEA), developed by Larry Alvord (of CIBA Vision Research, Development and Engineering) and colleagues, models a contact lens on the eye in two dimensions and provides for a three-dimensional analysis of the lens on the corneal surface: from the center of the lens to its periphery and from the pre-lens tear film to the corneal endothelium. Previous one-dimensional models evaluated only the center of a lens.
Through their analyses, the researchers found that supplying adequate amounts of oxygen to the corneal periphery is more challenging, yet critically necessary, than supplying the central cornea. Thus, the minimum contact lens Dk/t required to allow adequate oxygenation of the cornea cannot be based on an analysis that considers only the center of the lens, as previous models have employed.
|CooperVision Adds to Online Learning Center|
CooperVision has added a selection of courses to its Online Learning Center (http://learning.coopervision.com) designed to help employees new to eye care gain a basic understanding of the vision system while improving overall practice efficiency and productivity. The free courses are part of the New to Eyecare track.
Virtually Try on Acuvue 2 Colours
Acuvue 2 Colours (Vistakon) now offers iMakeover at www.imakeover.acuvue.com. Patients can upload their photo to the site to see what they would look like with different Acuvue 2 Colours. The site also offers beauty tips from makeup artist Mally Roncal and a free trial pair certificate.
CIBA Vision Launches FreshLook Color Studio Web Site
Patients can now virtually try on CIBA Vision's FreshLook colored contact lenses at the FreshLook Color Studio, a new section of freshlookcontacts.com. Patients can upload their photo, select a FreshLook color and then see the new look. Patients can also print their favorite on a free trial certificate.
Contact Lens Spectrum, Issue: December 2007