NEWS spectrum

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.

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.

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.

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.