Market Overview

CMS Issues Preliminary Decision on Unique J Code for Avedro Photrexa® Drug Formulations


., an ophthalmic pharmaceutical and medical device company and
world leader in corneal remodeling, today announced that the Centers for
Medicare and Medicaid Services (CMS) has issued a preliminary decision
to establish a product specific Healthcare Common Procedure Coding
System (HCPCS) J code for Photrexa® drug formulations. Claims
submitted with a product specific J code are generally processed more
efficiently than claims using a miscellaneous code (J3490), which
requires manual review.

These Photrexa formulations are the only drugs approved by the U.S. Food
and Drug Administration (FDA) for use in conjunction with the KXL®
System in corneal collagen cross-linking to treat progressive
keratoconus and corneal ectasia following refractive surgery.

"We are pleased that CMS has recommended a unique J code for our
Photrexa drugs," said Reza Zadno, PhD, CEO of Avedro. "We would like to
thank the ophthalmologists, the societies and the National Keratoconus
Foundation for working with us in this collaborative effort.
Finalization of this recommendation would be an important achievement
for the company as we continue our efforts to make corneal cross-linking
an accessible procedure for patients struggling with sight-threatening

"If finalized, this J code will simplify billing for the FDA approved
corneal cross-linking procedure," said Eric Donnenfeld, MD, founding
partner of Ophthalmic Consultants of Long Island and Connecticut. "A
product specific J code will streamline the claims submission process
for physician practices and better serve ectactic patients in need of

CMS' preliminary decision was announced at their public meeting held on
Tuesday, May 15, 2018, and is expected to be finalized and announced in
November of 2018, with new or revised codes becoming effective on
January 1, 2019.

Avedro, Inc.

Avedro is a privately held pharmaceutical and medical device company and
the world leader in corneal remodeling. Our patented cross-linking
technology, consisting of drug formulations and medical devices, are
approved for sale in numerous countries around the globe. We continue to
develop proprietary corneal remodeling products for the treatment of
keratoconus, corneal ectasia and for refractive correction as an
alternative to contacts and eyeglasses. Keratoconus and corneal ectasia
are rare and sight-threatening eye conditions in which the cornea
progressively thins and weakens causing the development of a cone-like
bulge and optical irregularity of the cornea which can result in
significant visual impairment. At Avedro, our mission is to produce and
deliver innovative, minimally invasive drugs and devices for corneal
remodeling to eyecare professionals around the world to improve
patients' vision and quality of life.



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.


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.


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


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

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.

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