Sunrise Looking To International Markets For Hyperion LTK Hyperopia System
This article was originally published in The Gray Sheet
Sunrise Technologies is looking toward international market opportunities for its Hyperion laser thermal keratoplasty (LTK) ophthalmic Holmium laser system following a July 22 "not approvable" recommendation for treatment of hyperopia from FDA's Ophthalmic Devices Panel (1"The Gray Sheet" July 26, p. 3).
You may also be interested in...
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.
REFRACTIVE SURGERY LASER REVISED DRAFT IDE GUIDANCE INCLUDES HIGH MYOPIA AND HYPEROPIA, WITH OR WITHOUT ASTIGMATISM; POLICY SLATED FOR PANEL REVIEW OCT. 21
Refractive lasers used to treat high myopia should provide uncorrected visual acuity (UCVA) of 20/40 or better in at least 75% of postoperative eyes, FDA says in a draft revision of its "Checklist of Information Usually Submitted in an Investigational Device Exemption for Refractive Surgery Lasers." The draft, released Sept. 5, defines high myopia as greater than -7.00 diopters, with or without astigmatism. For hyperopia (with or without astigmatism), the target endpoint for UCVA of 20/40 cited is 85%.
New guidance from the UK regulator covers distribution and deployment of Pfizer/BioNTech's COVID-19 vaccine, which will be complex because of the temperature storage requirements and the large packs in which the vaccine doses will be delivered.