Business Wire

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

Jaa

Avedro, 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 States1.

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.

About 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.

References:

  1. Borderie VM, Boelle PY, Touzeau O, et al. Predicted long-term Outcome of corneal transplantation. Ophthalmology 2009;2354-2360 Eye Bank Association of America Statistical Report, 2016

Contact information

Avedro Contact:
Avedro, Inc.
David Iannetta, 781-768-3400
info@avedro.com
or
Media Contact:
Gray Communications, LLC.
Michele Gray, 917-449-9250
michele_gray@me.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Toshiba Memory and Western Digital Celebrate the Opening of Fab 6 and Memory R&D Center at Yokkaichi, Japan19.9.2018 07:00Tiedote

Toshiba Memory Corporation and Western Digital Corporation (NASDAQ:WDC) today celebrated the opening of a new state-of-the-art semiconductor fabrication facility, Fab 6, and the Memory R&D Center, at Yokkaichi operations in Mie Prefecture, Japan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180918006193/en/ Fab 6 and Memory R&D Center, Yokkaichi Operations (Photo: Business Wire) Toshiba Memory started construction of Fab 6, a dedicated 3D flash memory fabrication facility, in February 2017. Toshiba Memory and Western Digital have installed cutting-edge manufacturing equipment for key production processes including deposition and etching. Mass production of 96-layer 3D flash memory utilizing the new fab began earlier this month. Demand for 3D flash memory is growing for enterprise servers, data centers and smartphones, and is expected to continue to expand in the years ahead. Further investments to expand its production wil

Hillhouse Capital Closes US$10.6 Billion Fund IV19.9.2018 05:29Tiedote

Hillhouse Capital announced today the close of Hillhouse Fund IV, L.P. The fund was heavily oversubscribed, closing with aggregate commitments of US$10.6 billion. From partnering with visionary founders at company inception, to undertaking buyouts of iconic brands, the flexibility of Hillhouse's mandate enables it to be highly selective in choosing investments. Hillhouse Fund IV will pursue opportunities across the healthcare, consumer, technology and services sectors globally, with a focus on Asia. With the new fund, Hillhouse will continue to work closely with entrepreneurs and management teams in pursuit of sustainable, long-term growth. In its private equity investments, Fund IV will implement Hillhouse's strategy of leveraging its extensive operating capabilities and deep understanding of technology to create long-term value. Hillhouse aims to reignite growth through digital enablement of traditional businesses, as it has done in the retail space with its buyout of Belle Internati

Rockwell Automation Opens Registration for 2018 Automation Fair18.9.2018 17:54Tiedote

Registration is now open for the 2018 Automation Fair, hosted by Rockwell Automation and members of its global PartnerNetwork program. The 27th annual Automation Fair will be held Nov. 12-15 at the Pennsylvania Convention Center. The event brings together approximately 10,000 manufacturers and producers from across the globe to learn about the newest innovations in automation and take part in training, industry forums and networking events. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180918005725/en/ Automation Fair will feature more than 150 exhibits showcasing the latest product innovations for industrial manufacturing and production. Hosted by Rockwell Automation and members of its PartnerNetwork, the event offers more than 400 hours of educational opportunities through forums, hands-on labs and technical sessions. (Photo: Business Wire) “The next industrial transformation is here – and meeting its demands requires a m

Seoul Semiconductor Supplies Optimal LEDs ‘SunLike’ to Large Scale Applications of Lumitronix in Germany18.9.2018 16:33Tiedote

Seoul Semiconductor Co., Ltd. (KOSDAQ 046890), a market leader in LED (light emitting diode) design and manufacturing, supplied the innovative LEDs “SunLike” to Lumitronix, the LED specialist located in Baden-Württemberg, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180918005626/en/ The Modules with SunLike LEDs. (Photo: Business Wire) In cooperation with Seoul Semiconductor, Lumitronix has also developed three optimal SunLike modules to provide customers with a standardized solution and expand its adoption in the lighting market. Two of the LED modules comply with the standard of Zhaga, a global association of lighting companies, for Book 7 L56W2 and Book 7 L28W2 and enable easy replacement in various industrial applications. The modules named LinearZ are available in one feet and two feet length. The model LinearZ 280-26 measures 280 mm and is equipped with 26 SunLike LEDs and has a light output of up to 700 lm.

Andersen Global Continues South American Expansion With BKM Berkemeyer18.9.2018 16:30Tiedote

Andersen Global announces further growth in South America with the signing of a Collaboration Agreement with BKM Berkemeyer, one of the oldest and largest law firms in Paraguay. With two locations in the capital city of Asunción, the firm has a headcount of nearly 150 professionals, including ten Partners and over 60 lawyers. Established in 1951, BKM Berkemeyer is led by Managing Partner Hugo Berkemeyer and provides legal solutions to both domestic and international clients. The firm delivers advice in all areas of law, including business and corporate, taxation, litigation, environment, employment and intellectual property, with a notable expertise in international transactions and business matters. BKM Berkemeyer also specializes in M&A’s, joint ventures, foreign investment, infrastructure, project finance and financial transactions, advising also on issues regarding telecommunications, water and energy projects. Hugo commented, “Our focus at BKM Berkemeyer has been to provide flexib

175 Million Europeans Have Sleep Apnoea, Highlighting Scale of Global Health Crisis18.9.2018 16:05Tiedote

Roughly 175 million Europeans have obstructive sleep apnoea, according to a late-breaking abstract presented by ResMed today at the European Respiratory Society’s annual ERS Congress in Paris. Leading researchers estimate 90 million Europeans have moderate to severe sleep apnoea, meaning they experience at least 15 breathing events an hour during sleep. These statistics are based on the latest scoring rules for determining one’s apnoea–hypopnoea index (AASM 2012) and are connected with a 16-country study announced in May 2018 that revealed an estimated 936 million people worldwide have sleep apnoea, a chronic sleep-disordered breathing condition associated with increased risk of mortality and reduced quality of life. The new global prevalence is nearly tenfold higher than the previous one – 100 million – estimated by the World Health Organization in 2007. European countries with the highest prevalence are: Russia, 40 million Germany, 26 million France, 24 million Ukraine, 13 million Sp

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme