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Permanent J Code Issued for Avedro’s Photrexa® Drug Formulations

November 20, 2018

WALTHAM, Mass.--(BUSINESS WIRE)--Nov 20, 2018--Avedro, Inc., a leading commercial-stage ophthalmic medical technology company and a global leader in corneal remodeling, today announced that the Centers for Medicare and Medicaid Services (CMS) issued a product-specific J code, J2787, for Photrexa ® Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) and Photrexa ® (riboflavin 5’-phosphate ophthalmic solution). These Photrexa formulations are the only drugs approved by the U.S. Food and Drug Administration (FDA) for use in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia following refractive surgery. J2787 will become effective on January 1, 2019, under the Healthcare Common Procedure Coding System (HCPCS) and is expected to stabilize payment policies and facilitate the billing process for physician practices and their patients.

J codes are developed and issued by CMS as part of the HCPCS coding system for reporting medical procedures and services. Once effective, physicians will be able to use J2787 to submit claims for Photrexa Viscous and Photrexa to commercial payors.

“We expect the permanent J code to positively impact patients and physician practices by providing much needed coding clarity. This achievement reflects the hard work, persistence and collaboration of ophthalmologists, the American Academy of Ophthalmology, the American Society of Cataract and Refractive Surgery, the Cornea Society and the National Keratoconus Foundation,” said Reza Zadno, PhD, Chief Executive Officer of Avedro. “Our recently expanded reimbursement team will immediately begin the process of informing payors and providers of this exciting change. We believe this new J code, and the fact that over 55 private payors now cover medically necessary corneal cross-linking, will help ensure that this procedure is even more accessible to patients struggling with keratoconus, a sight-threatening disease.”

Patients can find the list of private payor insurance companies providing coverage for corneal cross-linking here: https://www.livingwithkeratoconus.com/

About Avedro, Inc.

Avedro is a leading commercial-stage ophthalmic medical technology company focused on treating corneal ectatic disorders and improving vision to reduce dependency on eyeglasses or contact lenses. Avedro’s proprietary Avedro Corneal Remodeling Platform strengthens, stabilizes and reshapes the cornea utilizing corneal cross-linking in minimally invasive and non-invasive outpatient procedures to treat corneal ectatic disorders and correct refractive conditions. The Avedro Corneal Remodeling Platform is comprised of Avedro’s KXL and Mosaic systems, each of which delivers ultraviolet A light, and a suite of proprietary single-use riboflavin drug formulations, which, when applied together to the cornea, induce a biochemical reaction called corneal collagen cross-linking.

IMPORTANT SAFETY INFORMATION

INDICATIONS Photrexa ® Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) and Photrexa ® (riboflavin 5’-phosphate ophthalmic solution) are indicated for use with the KXL System in corneal collagen cross-linking (CXL) for the treatment of progressive keratoconus and corneal ectasia following refractive surgery.

LIMITATIONS OF USE The safety and effectiveness of CXL has not been established in pregnant women, women who are breastfeeding, patients who are less than 14 years of age and patients 65 years of age or older.

Photrexa Viscous and Photrexa should be used with the KXL System only.

WARNINGS AND PRECAUTIONS Ulcerative keratitis can occur. Patients should be monitored for resolution of epithelial defects.

ADVERSE REACTIONS In progressive keratoconus patients, the most common ocular adverse reactions in any CXL treated eye 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.

These are not all of the side effects of Photrexa ® Viscous, Photrexa ® and the CXL treatment. For more information, see Prescribing Information.

You may report an adverse event to Avedro by calling 1-844-528-3376, Option 1 or you may contact the U.S. Food and Drug Administration (FDA) directly at 1-800-FDA-1088.

View source version on businesswire.com:https://www.businesswire.com/news/home/20181120005355/en/

CONTACT: Avedro Contact:

David Iannetta

Avedro, Inc.

(781) 768-3400

info@avedro.comMedia Contact:

Michele Gray

Gray Communications, llc.

(917) 449-9250

michele_gray@me.com

KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY OPTICAL PHARMACEUTICAL FDA

SOURCE: Avedro, Inc.

Copyright Business Wire 2018.

PUB: 11/20/2018 08:00 AM/DISC: 11/20/2018 08:01 AM

http://www.businesswire.com/news/home/20181120005355/en

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