Vistakon
Contact lens approved for therapeutic use as a bandage lens
for a range of acute and chronic ocular conditions
Vistakon®, Division of Johnson & Johnson Vision Care, Inc., today announced that the U.S. Food & Drug Administration has granted an additional indication for ACUVUE® OASYS™ Brand Contact Lenses with HYDRACLEAR™ PLUS, approving the lens for therapeutic use as a bandage lens for certain acute and chronic ocular conditions. ACUVUE OASYS for therapeutic use can also provide vision correction during healing if required.
“Many therapeutic soft lens applications require regular use and overnight wear for several days, or sometimes longer,” explains Sheila Hickson-Curran, Director, Medical Affairs, VISTAKON. “The wettability, smoothness, flexibility, high oxygen transmissibility, comfort, and Class I UV blocking†* properties of ACUVUE OASYS make it an excellent choice for therapeutic use as a bandage lens for a range of conditions.”
“Under certain conditions, the use of a silicone hydrogel lens like ACUVUE OASYS can help protect the cornea from exposure or repeated irritation often caused by rubbing during the wound healing process, and assist in pain relief,” explains William B. Trattler, MD, a cornea specialist at the Center for Excellence in Eyecare in Miami, FL, and a volunteer assistant professor at Bascom Palmer Eye Institute. “For my patients, I have also found that ACUVUE OASYS works wonderfully as a bandage contact lens for laser vision correction, as it reduces discomfort.”
A clinical study was conducted for this therapeutic indication through a retrospective collection of data. Study records were evaluated from 43 subjects who were fit with ACUVUE OASYS in therapeutic applications. The cases demonstrate that the use of this lens is efficacious for the reduction of corneal exposure, pain management, barrier protection, and prevention of recurrent damage. There were no safety issues observed in any of the reported cases.
FDA approval of ACUVUE OASYS for therapeutic use as a bandage lens includes the following acute and chronic ocular conditions:
Acuvue Oasys Additional Indication/2
- For corneal protection in lid and corneal abnormalities such as entropion, trichiasis, tarsal scars and recurrent corneal erosion. In addition, it 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.
- For corneal pain relief in conditions such as bullous keratopathy, epithelial erosion and abrasion, filamentary keratitis, post-keratoplasty.
- 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.
- For post surgical conditions where bandage lens use is indicated such as post refractive surgery, lamellar grafts, corneal flaps, and additional ocular surgical conditions
- For structural stability and protection in piggy back lens fitting where the cornea and associated surfaces are too irregular to allow for corneal rigid gas permeable lenses to be fit. In addition, the use of the lens can prevent irritation and abrasions in conditions where there are elevation differences in the host/graph junction or scar tissue.
ACUVUE OASYS also is indicated for daily wear vision correction and may also be worn for up to 6 consecutive nights/7 days of extended wear as recommended by an eye care professional. ACUVUE OASYS can be worn continuously for up to six nights and seven days when used as a therapeutic lens. Contact lenses should not be worn for longer periods than recommended by an eye care professional. As with all contact lenses, eye problems, including corneal ulcers, can develop. Some wearers may experience mild irritation, itching or discomfort. When intended for vision correction, lenses should not be prescribed if patients have any eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems. Consult the package insert for complete information. Complete information is also available from VISTAKON® by calling 1-800-843-2020 or by visiting www.ecp.acuvue.com.
Johnson & Johnson Vision Care Inc.
The VISTAKON division of Johnson & Johnson Vision Care, Inc. specializes in disposable contact lenses which it markets under such brand names as ACUVUE®, ACUVUE® ADVANCETM with HYDRACLEAR™, ACUVUE® ADVANCETM for ASTIGMATISM, ACUVUE® OASYS™ with HYDRACLEAR™ PLUS, ACUVUE® and ACUVUE® 2; 1-DAY ACUVUE® ;ACUVUE® BIFOCAL ; ACUVUE® TORIC, and ACUVUE® 2 COLOURSTM.
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