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Biotech / Medical : SNRS- Sunrise Technologies -- Ignore unavailable to you. Want to Upgrade?

To: Gordon A. Langston who wrote (2963)	8/7/1999 10:47:00 PM
From: BARRY ALLEN	Read Replies (1) \| Respond to of 4140

Can you believe the POWER that Grimmett and Macsai wielded??? *Panel remained skeptical* Although the panel did not dispute the safety of the Hyperion, they did challenge the device?s efficacy. Two primary panel reviewers said the device was not approvable. Panel reviewer Marian S. Macsai, MD, leveled the first criticisms of the data. Reviewing nine tables of clinical study data, she noted that there was a decreasing number of patients whose visual acuity could be evaluated ? especially those who could be shown to have uncorrected visual acuity of 20/20 or better ? from the 6-month to the 24-month follow-up period. Dr. Macsai noted that when only a low degree of refractive correction is attempted, coming within 1 D of the intended correction may not be sufficient. She said that she wanted to see follow-up of at least 2 years of data to establish if there is refractive drift resulting from the procedure. The other panel reviewer, Michael R. Grimmett, MD, said that the lack of cycloplegic refractions was a problem. All patients enrolled in the LTK study were 40 years of age or older, but ?residual accommodative reserve, if any, may skew results,? he said. Dr. Grimmet said that the decreasing number of eyes available after 6 months eliminates the chance of making any conclusions about stability. He suggested that because continuous refractive shift occurs with time, ?most of the refractive effect is temporary?. The average consumer will want more than a temporary refractive effect.? He interpreted this as poor efficacy and told the rest of the panel that the de vice was not approvable since it has not been shown to be effective. He also recommended the company submit another PMA application with more 2-year data.