Early stage IT and Healthcare Investing

First US Service Members Treated with the Only FDA-Approved Cross-Linking Procedure in the U.S.

latestnews

First US Service Members Treated with the Only FDA-Approved Cross-Linking Procedure in the U.S. Jan 2017

Avedro Provides the Only FDA approved Therapeutic Treatment for Progressive Keratoconus

Logo

Jan. 10, 2017 05:00 UTC

First US Service Members Treated with the Only FDA-Approved Cross-Linking Procedure in the U.S.

Avedro Provides the Only FDA approved Therapeutic Treatment for Progressive Keratoconus

WALTHAM, Mass.--(BUSINESS WIRE)-- Avedro, Inc., an ophthalmic pharmaceutical and medical device company, has begun selling Photrexa Viscous® (riboflavin 5-‘phosphate in 20% dextran ophthalmic solution), Photrexa® (riboflavin 5’-phosphate ophthalmic solution) and the KXL® System to key military hospitals around the country. Fort Belvoir Hospital, located in Fort Belvoir, VA, made history on November 21st to become the first military facility in the country to perform FDA-approved corneal cross-linking, treating service members with progressive keratoconus.

“Military careers are often cut short when a service member is unable to be deployed due to being diagnosed with keratoconus. Previously, the only solution for these service members with progressive keratoconus was to wear specialized contact lenses. Because contact lenses aren’t approved for combat, otherwise great service members were forced to end their military careers before they intended,” explained Army Col. Bruce Rivers, staff ophthalmologist and program director of the Warfighter Refractive Eye Surgery Program and Research Center at Belvoir Hospital. “This treatment at Belvoir Hospital provides hope to U.S. service members who now have a treatment that may allow them to be deployed.”

Fort Belvoir Hospital treats more than 571,000 patients each year, including 56 percent active-duty service members and their families, and 44 percent retirees.

Since Avedro announced their full launch in September, the company has expanded into several military markets and shipped out treatments for several thousand patients.

“Avedro has experienced a lot of momentum since we starting shipping product in September,” said Reza Zadno, PhD, CEO, Avedro. “We are very proud of our role in helping patients with these sight-threatening diseases.”

Corneal collagen cross-linking with Avedro’s Photrexa Viscous, Photrexa and the KXL system is the first and only corneal cross-linking therapy approved by the FDA. Patients should consult their ophthalmologist to determine if corneal cross-linking is right for them. Patients and families can locate an ophthalmologist performing this procedure using the “Find a Physician” tool on Avedro’s website www.avedro.com.

What are Photrexa Viscous and Photrexa?
PHOTREXA VISCOUS and PHOTREXA are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia following refractive surgery.

Important Safety Information
In progressive keratoconus patients, the most common ocular adverse reactions were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision.

In corneal ectasia patients, the most common ocular adverse reactions were corneal opacity (haze), corneal epithelium defect, corneal striae, dry eye, eye pain, punctate keratitis, photophobia, reduced visual acuity, and blurred vision.

Ulcerative keratitis can occur, and patients should be monitored for resolution of epithelial defects.

It is not known if CXL is safe and effective in pediatric patients below the age of 14 years

Please see full Prescribing Information by clicking here: http://avedro.com/wp-content/uploads/dlm_uploads/13597/

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

About Keratoconus
Keratoconus is a progressive thinning and distortion of the cornea. It is the most common corneal dystrophy in the US, affecting approximately one in every 2,000 Americans1 or approximately 170,000 people in the US. Keratoconus causes the cornea to bulge from its normal symmetric domelike smooth optical shape, creating an abnormal curvature that changes the cornea's optics, producing blurred and distorted vision that is difficult to correct with spectacle lenses. This progressive thinning and weakening can result in significant visual loss and may lead to corneal transplants.

About Corneal Ectasia
Corneal ectasia, a non-inflammatory condition marked by progressive corneal steepening and thinning, is a rare but serious complication of vision correction procedures. The condition can begin within a week of surgery or after several years and is associated with worsening best-uncorrected visual acuity, an increase in ocular aberrations, and decreasing best-corrected distance visual acuity.

About Avedro, Inc.
Avedro is a privately held pharmaceutical and medical device company and is the world leader in corneal remodeling. Avedro’s Photrexa Viscous, Photrexa and KXL products are approved for sale in the United States for the treatment of progressive keratoconus and corneal ectasia following refractive surgery. Outside of the United States Avedro is developing the PiXL procedure, the next generation in refractive correction, as a non-invasive approach to vision improvement.

1 National Eye Institute (NEI). Facts About The Cornea and Corneal Disease. http://www.nei.nih.gov/health/cornealdisease/#12

Contacts

 

Contact:
Avedro, Inc.
David Iannetta, 1-844-528-3376
info@avedro.com
or
Media:
BioComm Network, Inc.
Michele Gray, 917-449-9250
michele_gray@me.com

Portfolio Press Releases

About InterWest

Facebook Google+ Twitter Email LinkedIn Share