SightGlass Vision announced topline data from the company’s pivotal trial evaluating its novel eyeglasses designed to slow the progression of myopia in children. Results from a planned 12-month interim analysis of the CYPRESS clinical study (NCT03623074) demonstrated a reduction in myopia progression in both test arms over control lenses, as assessed by the co-primary outcome measures of axial length and cycloplegic spherical equivalent refraction (SER) change.
Data showed both test arms met superiority in terms of cycloplegic SER change from baseline, with a reduction in myopia progression of up to 74 percent at 12 months (P<0.0001 for both test arms). For the same time period, results also showed both test arms met superiority in terms of axial length change from baseline, with a reduction in axial length progression of up to 50 percent at 12 months (P<0.0001 and P=0.0018 for the two test arms). These data were published in a Review of Myopia Management white paper, which also discusses the pathophysiology of myopia and includes background about the company’s technology.
A link to the white paper can be found at https://bit.ly/2RYbztj.
“This is a terrific result, truly a ‘home run’ in the global effort to reduce myopia progression in children,” Earl L. Smith III, OD, PhD, FAAO, FARVO, Greeman-Petty Professor, Vision Department and Interim Chief Health Officer, University of Houston, Texas, said in a company news release. “It is quite exciting to see these results for both test arms in such a rigorously designed clinical trial. I look forward to seeing future data as I believe these innovative spectacles could be a game changer in the management of myopia in children around the world.”
CYPRESS (Control of Myopia Using Peripheral Diffusion Lenses: Efficacy and Safety Study) is a prospective, multicenter, subject- and observer-masked, randomized, controlled pivotal clinical study in 256 children aged 6-to-10 years old across 14 trial sites in the U.S. and Canada. At the time of enrollment, study participants had myopia between -0.75 D and -4.50 D (SER). Trial participants are using one of three types of lenses instead of their normal glasses: control lenses or one of two test lens designs. Following assessments at baseline, participants are followed for progression of myopia over 36 months.
Safety results from the 12-month planned interim analysis showed that for each group, all measures of visual acuity remained clinically stable through month 12 and no serious adverse events were reported.
“As a myope since I was a young boy, I can remember the challenges I faced and how I was inspired at an early age to dedicate my career to pursue a scientific discovery that could help improve the eyesight of people,” said Jay Neitz, PhD, Professor and Research Director, Department of Ophthalmology, and Co-director, Neitz Lab, University of Washington, and co-founder of SightGlass Vision. “Myopia continues to increase dramatically around the world, and new therapies to prevent myopia progression, particularly in young children, are urgently needed. The 12-month findings from CYPRESS are promising. I look forward to seeing our novel spectacles come to fruition, so that we can help hundreds of millions of children around the world who continue to be at risk for vision-threatening complications due to high myopia.”
“We are incredibly encouraged by these initial findings, especially given the young age of our subjects, whose eyes are still physiologically growing. We now have definitive data to show that our novel eyeglasses reduce the progression of nearsightedness in children. We look forward to continuing this ongoing study and sharing additional planned data with the scientific community,” said Joe Rappon, OD, MS, FAAO, Chief Medical Officer.
Data from the CYPRESS pivotal trial will be used to support registration and market launch of the Company’s novel spectacle lenses. A 24-month interim data analysis is planned for next year. Visit www.clinicaltrials.gov for more information about CYPRESS.