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Deficient Long-Term Data Render Sunrise Hyperopia Tool Not Approvable

This article was originally published in The Gray Sheet

Executive Summary

Forty-six percent of the eyes treated with Sunrise Technologies' Hyperion laser thermal keratomileusis (LTK) system for hyperopia in clinical trials were under-corrected by greater than 1.00 diopter twenty-four months post-treatment, data contained in the firm's premarket approval application showed.

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Sunrise Technologies International, Inc

Advises shareholders to reject an unsolicited tender offer for up to 2.3 mil. shares at $12.50 each from Growth Capital Corp. The offer covers about 5% of Sunrise's approximately 45.7 mil. shares outstanding. "The price is inadequate and shareholders have no withdrawal rights," Sunrise warns Dec. 14. "Tenders of shares made pursuant to the offer are irrevocable, even if the offer is extended," leaving open the possibility that payment could be delayed indefinitely and shareholders would have no ability to liquidate their investment, Sunrise notes. The company's Hyperion LTK Holmium laser system for treatment of hyperopia is slated for its second review by FDA's Ophthalmic Devices Panel at its Jan. 13-14 meeting. The panel deemed the device not approvable in July, citing deficient long-term data (1"The Gray Sheet" July 26, p. 3). Additional data have since been submitted in support of the firm's premarket approval application covering reduction of hyperopia of +0.75 to +2.50 diopters

Sunrise Technologies International, Inc

Advises shareholders to reject an unsolicited tender offer for up to 2.3 mil. shares at $12.50 each from Growth Capital Corp. The offer covers about 5% of Sunrise's approximately 45.7 mil. shares outstanding. "The price is inadequate and shareholders have no withdrawal rights," Sunrise warns Dec. 14. "Tenders of shares made pursuant to the offer are irrevocable, even if the offer is extended," leaving open the possibility that payment could be delayed indefinitely and shareholders would have no ability to liquidate their investment, Sunrise notes. The company's Hyperion LTK Holmium laser system for treatment of hyperopia is slated for its second review by FDA's Ophthalmic Devices Panel at its Jan. 13-14 meeting. The panel deemed the device not approvable in July, citing deficient long-term data (1"The Gray Sheet" July 26, p. 3). Additional data have since been submitted in support of the firm's premarket approval application covering reduction of hyperopia of +0.75 to +2.50 diopters

Sunrise Sets November Date For Hyperion Amended PMA Submission

Sunrise Technologies has decided not to pursue a stability indication for its Hyperion laser thermal keratoplasty (LTK) ophthalmic laser system, in an amended premarket approval application to be filed in early November.

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