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Sunrise plans purely statistical talks with FDA
Company’s president said an advisory panel’s debate “ignored” data.
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FREMONT, Calif. — Sunrise Technologies intends to argue its case on purely statistical grounds when it continues talks with the Food and Drug Administration (FDA) regarding its Hyperion laser to correct farsightedness.
The FDA’s Ophthalmic Devices Panel recommended the agency not approve the device due to fears about regression of effect. However, the FDA will continue talks with Sunrise and could decide to approve the product anyway.
Sunrise president and chief executive officer C. Russell Trenary III said the company can talk on a purely statistical basis with the agency and still receive approval. He conducted a press conference exclusively with members of the ophthalmic press to discuss clinical issues. The company has held other press conferences with investors and other lay media members about other economic issues.
“Where we want to be is in a statistical discussion,” he said. “I don’t see much emotion that comes out of the agency, I just see a lot of, kind of hard-nosed reasoning based on the statistics. We have a very large, significant body of clinical data that we presented [at the panel meeting] that, although it appeared like it was ignored by the panel, I don’t think it was lost on the FDA.”
He added the company can statistically prove its treatment has a lasting effect.
“The FDA, with their plethora of statisticians, and ophthalmologists, and optometrists, and engineers, and scientists, they’re used to looking at data and sample sizes in terms of statistical significance,” he said. “That’s where the argument will rest.”
Panel chairman James P. McCulley, MD, said that he would not comment on the meeting, but added that the meeting transcript is available and speaks for itself.
The panel is composed of ophthalmologists, optometrists and statisticians, many of whom are refractive surgeons and most of whom have academic affiliations, as well as clinical practices.
For Your Information:
- Sunrise Technologies is located 47257 Fremont Blvd., Fremont, CA 94538; (510) 623-9001; fax: (510) 623-9008.