To: majormember who wrote (203 ) 11/19/1997 6:19:00 PM From: BARRY ALLEN Respond to of 4140
Skane, it's BLASTOFF! Wednesday November 19, 5:20 pm Eastern Time Company Press Release Phase III Approval from FDA for Sunrise Technologies' Hyperopia Study FREMONT, Calif.--(BW HealthWire)--Nov. 19, 1997--Sunrise Technologies International, Inc. (OTC BB:SNRS - news) announced it has received approval from the FDA to move into the final phase for their study on treating hyperopia. ''Approval to begin our third and final phase for treating hyperopia is a huge milestone because it brings us that much closer to being able to file for pre-market approval,'' according to C. Russell Trenary III, President and Chief Executive Officer. Jeannie Gifford Cecka, Vice President, Clinical and Regulatory Affairs, explained that the amount of expertise targeted at the current study is impressive. ''For us to be in the final phase now is a tribute to our team. Dr. Douglas D. Koch from the Cullen Eye Institute, Baylor University, Houston, TX, Dr. Donald Sanders from the Center for Clinical Research in Elmhurst, IL, and BioReg and Associates in Laurel, MD, have made significant contributions to the clinical study resulting in a well-controlled, high quality investigation. This team, in conjunction with our U.S. clinicians continues to deliver tremendous expertise and results. We will enroll at most 200 additional patients to complete our hyperopia study.'' Dr. Koch (Medical Monitor for Sunrise's clinical studies) explained that patient satisfaction from the Sunrise Laser Thermal Keratoplasty (LTK) treatments is excellent. ''This treatment yields impressive results both short term and long term. We reported at the 1997 American Society of Cataract and Refractive Surgery (ASCRS) meeting that between 6 months and 3 years, post operative regression is negligible. To our knowledge, no other treatment for hyperopia has demonstrated that. Also, the near-term post-operative course for hyperopia is interesting. As the patient regresses from a little nearsightedness to normal vision, they are usually quite satisfied. These formerly farsighted patients initially gain the ability to see near, which is quite satisfying, and then their distance vision improves during the post-operative course. Oftentimes, they end up with vision that has improved near and far.'' Dr. Alan Aker from the Aker-Kasten Cataract and Laser Institute in Boca Raton, FL, believes patients treated with the Sunrise CorneaSparing LTK(TM) System are among the most satisfied. ''Compared to nearsighted patients, farsighted patients tend to be happier and more grateful for the improvement they receive. The Sunrise patients are among our best ambassadors at our practice.'' As a final comment, Trenary revealed, ''This year has been a very positive one for Sunrise. We have attracted 100 years of ophthalmic or laser experience to the senior management team, we have revealed that we have compelling clinical data for treating hyperopia, and now we are in the final phase of our FDA clinicals. The New Sunrise Team is performing according to plan, and the proof is in what we have accomplished recently and by the company we keep. Some of the most skilled and respected ophthalmologists in the world have agreed to participate in our clinical trials.'' biz.yahoo.com