Avedro Announces Enrollment of First Patient in U.S. Pivotal Phase 3 Epi-on Corneal Cross-Linking Trial for Progressive Keratoconus

Inc., an ophthalmic pharmaceutical and medical device company and
the world leader in corneal remodeling, today announced that it has
begun enrolling patients in a pivotal Phase 3 clinical trial to evaluate
the safety and efficacy of an epithelium-on (epi-on) corneal collagen
cross-linking procedure to treat patients with progressive keratoconus. Keratoconus
is a non-inflammatory eye condition in which the typically round
dome-shaped cornea progressively thins and weakens and is the leading
cause of penetrating keratoplasty (corneal transplant) in the United

The Phase 3 clinical trial, ACP-KXL-308,
is a multicenter, randomized, controlled study of a novel corneal
cross-linking procedure of 275 patients with progressive keratoconus
across approximately 20 sites in the United States. As is typical for
U.S. Food and Drug Administration (FDA) drug trials, investigational
treatments are provided at no cost to participating patients.

“As a practitioner who has treated many patients with progressive
keratoconus in previous clinical studies, the commencement of this
epi-on cross-linking study represents another important milestone. This
procedure, designed to eliminate the need to remove the epithelium, has
the potential to be of great value to patients and practices alike,”
said Michael B. Raizman, MD, clinical investigator and practicing
ophthalmologist at Ophthalmic Consultants of Boston.

“Since the 2016 FDA approval of Avedro’s epi-off cross-linking
treatment, thousands of patients with progressive keratoconus, a
potentially debilitating disease, have benefited from this procedure,”
said Rajesh K. Rajpal, MD, Chief Medical Officer for Avedro and Founder
of See Clearly Vision in the Washington D.C. area. “We are proud to
continue our efforts to serve these patients and the doctors who treat
them with this trial, which is the first and only epi-on study currently
intended to support an FDA approval filing.”

“The start of this study is exciting news for patients,” said Mary
Prudden, Program Director, National Keratoconus Foundation. “We are
pleased to see continued innovation in corneal cross-linking
technologies and are hopeful that this research will ultimately lead to
a second FDA-approved option for patients living with this rare and
sight-threatening condition.”

The current list of participating study sites include Massachusetts,
Ohio, Utah, Pennsylvania and Virginia. As new sites are initiated, they
will be listed on clinicaltrials.gov.

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. For more information, visit www.Avedro.com.


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