SightGlass Vision Unveils Topline Data From CYPRESS Pivotal Study of Novel Eyeglasses Designed to Control Myopia in Children
- Data demonstrated superiority of both test arms in co-primary outcome measures of axial length and cycloplegic spherical equivalent refraction (SER) over control lenses at 12-month planned interim analysis
-- SER: Both test arms were superior, showing up to 74 percent reduction in the progression of myopia to Month 12
-- Axial length: Both test arms were superior, showing up to 50 percent reduction in axial length progression to Month 12
- Topline results published in Review of Myopia Management white paper, which also discusses myopia pathophysiology and mechanism of action of DOT lenses
- Ongoing CYPRESS clinical study in children aged six-to-10 years old across 14 trial sites in U.S. and Canada
PALO ALTO, Calif., April 27, 2020 /PRNewswire/ -- SightGlass Vision, Inc., a clinical-stage life sciences company focused on ending nearsightedness (myopia), today 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.
Earl L. Smith III, OD, PhD, FAAO, FARVO, Greeman-Petty Professor, Vision Department and Interim Chief Health Officer, University of Houston, Texas, commented, "This is a terrific result, truly a 'home run' in the global effort to reduce myopia progression in children. 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, multi-center, subject- and observer-masked, randomized, controlled pivotal clinical study in 256 children aged six-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, Ph.D., 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.
About Myopia Nearsightedness or myopia is a condition that occurs when the light coming into an eye does not focus on the retina, but in front of it, making things look blurry. For most people, myopia is usually a minor inconvenience and is correctable. However, myopia increases the risk of serious eye conditions such as myopic maculopathy, retinal detachment, and glaucoma, making it one of the leading causes of visual impairment and blindness.
Myopia has seen a dramatic increase in prevalence over the past several decades. In the early 1970's, only 25 percent of Americans were nearsighted. By the early 2000's, that number had jumped to more than 40 percent. Today, the number of nearsighted people is at epidemic proportions globally. Myopia is the leading cause of irreversible blindness in parts of Asia. Most alarming is approximately half of all young adults in the U.S. and Europe are nearsighted – double the number from when their grandparents were the same age. And in China, about 80 to 90 percent of teens and young adults are myopic, up from 10 to 20 percent just 65 years ago. It is estimated that almost half of the entire world's population, or five billion people, will be nearsighted by 2050. This increase is thought to relate to lifestyle changes, including less time outdoors and more eye-straining or near work-related activities such as reading and screen time. Early intervention is key to preventing high myopia from developing.
About SightGlass Vision, Inc. SightGlass Vision, Inc. is a clinical-stage life sciences company focused on ending nearsightedness (myopia). Headquartered in Palo Alto, CA, SightGlass is developing innovative spectacle lenses to reduce the progression of myopia in children. Based on groundbreaking research from the University of Washington, SightGlass was founded in 2016 by Professors Jay and Maureen Neitz, who are world-renowned vision researchers, and Dr. Thomas Chalberg, a serial entrepreneur in the biotechnology and medical device sectors. For more information, please visit www.sightglassvision.com.