DALLAS--(BUSINESS WIRE)--Refocus Group, Inc. (www.Refocus-Group.com), a medical device company that has developed a unique, highly innovative scleral procedure for the restoration of near vision in presbyopic patients, today announced the appointment of Michael (Mike) Judy as President and Chief Executive Officer. Judy, a 30-year veteran in refractive and ophthalmic device sales and marketing, was most recently the Chief Commercialization Officer at AcuFocus in charge of global sales and marketing, where he interfaced with manufacturing, research and development, and clinical and regulatory personnel at AcuFocus to ensure rapid growth and high patient and doctor satisfaction on a global basis. Judy will assume his new responsibilities at Refocus effective October 28, 2013. Doug Williamson the current CEO will be commencing a new board level role within the company, which will entail ongoing involvement in management operations to assist in the transition process.
Refocus Group is engaged in the research and development of treatments for human vision disorders. The Company’s mission is to become the preferred surgical alternative for the treatment of presbyopia in pre-cataract patients. Refocus will also provide a surgical alternative to significantly lower ocular pressure in early stage glaucoma or ocular-hypertensive patients.
Refocus Group’s main product is the Refocus Scleral Implant used in a revolutionary extra-ocular procedure to restore near vision, which reduces or eliminates the need for reading glasses in the near emmetrope, presbyopic patient. Refocus Group is currently conducting a pivotal FDA IDE clinical trial in the United States, and completed enrollment of the 330-patient FDA cohort in October of 2012. Refocus’ products bear the CE Mark in the European Union with early commercialization commencing in 2013. In support of that marketing launch, Refocus has also commenced a multi-center clinical study for the treatment of presbyopia in key centers throughout the European Union. Refocus also has ongoing clinical studies in Europe to further substantiate the benefits of the Refocus procedure for early stage glaucoma and ocular hypertensive patients.
David Schanzlin, the Chief Investigative Officer for Refocus, remarked: “Since I joined Refocus in late 2011, we have seen remarkable improvements in the Refocus surgical technique which have made the procedure more precise, faster, and more comfortable for the patient. We have finished recruitment for the FDA pivotal study for presbyopia, and are completing data collection for the two-year follow-up. At present, we are on target to meet and/or exceed the primary endpoints for the FDA study. Importantly, we believe that the Refocus procedure is uniquely positioned against other surgical procedures for the presbyopic patient, as it is extra-ocular and entirely outside of the visual axis, eliminating any loss of distance vision, or halos, starbursts, or ghost images. The procedure is also binocular, so there is no loss of depth perception or contrast sensitivity. The addition of Mike Judy as CEO of Refocus should accelerate the broader understanding and benefits of the Refocus procedure, and facilitate acceptance of Refocus as one of the leading providers of solutions for presbyopia worldwide.”
Glen Bradley, Chairman of the Board at Refocus, said: “I am very pleased to welcome Mike to Refocus. His significant experience in building successful ophthalmology companies will prove invaluable as Refocus begins its next stage of development. Mike will play a pivotal role in helping us submit our presbyopia treatment for FDA approval and in continuing to commercialize the treatment throughout Europe.”
Further comment was made by Barrie Soloway, Medical Director at Refocus: “As we finish our two year follow-up and approach the filing of the final modules in the FDA IDE approval process, the knowledge Mike has of the intricacies of the submission process will be invaluable.”
Mike Judy added: “I have been impressed with the progress made by Refocus underpinned by some exciting and impressive clinical results; I welcome this opportunity to contribute to the company’s future advancement. The presbyopia correction market is significant with 110 million presbyopes in the United States, and 1.7 billion worldwide. The presbyopia market has many of the attributes of the early LASIK correction market, which saw dramatic growth in refractive procedures when laser technology was first launched in the 1990’s - growth that continues on a global basis to this day. I believe that Refocus is well positioned to take advantage of the tremendous demand for a dynamic binocular solution for presbyopia, and I look forward to helping the team exploit the value of its unique technology.”
Prior to joining Refocus, and prior to his responsibilities as Chief Commercial Officer at AcuFocus, Judy served as vice president, global marketing for Bausch & Lomb and was responsible for setting strategic direction for the Company’s global surgical business. His extensive background in marketing and sales has also included leadership positions with Eyeonics, Allergan’s IOL Surgical division (now a part of Abbott Medical Optics), and Pharmacia.
About Presbyopia
Presbyopia, a part of the normal aging process, reduces the ability of the eye to focus on near objects, usually at 40 – 45 years of age and beyond. There are many theories regarding the origin of presbyopia including loss of flexibility in the crystalline lens over time. Other theories highlight changes in the orientation of the internal muscles versus the crystalline lens. The lens allows accommodation in younger patients to occur by changing shape, but this ability to change shape diminishes as the patient grows older. Presbyopia is not a disease and it cannot be prevented. Traditionally, most people with presbyopia have had to use reading glasses to improve their near vision.
About Refocus Group and the Scleral Implant
The Refocus Presbyopia Correction treatment is performed outside the optical zone on a binocular basis. The treatment utilizes an innovative Scleral Implant, along with specialized instrumentation including the Oculock and Scleratome for exact placement and precise creation of the scleral tunnels. Early data from the ongoing IDE FDA pivotal study presented October 2013 at the ESCRS in Amsterdam, showed that the percentage of binocular eyes achieving 20/40 or better vision at 24-months follow-up to be 97%, with an average increase of 3 lines of near acuity.
To find out more about the Refocus scleral procedure please visit www.refocus-group.com or contact Zack Thompson at Refocus, 10300 North Central Expressway, Suite 104, Dallas, TX 75231, USA (214) 368-0200
