SightGlass Vision, Inc., a clinical-stage life sciences company focused on ending nearsightedness (myopia), today announced topline results from a planned 12-month interim analysis of the Company’s pivotal trial evaluating its novel eyeglasses designed to slow the progression of myopia in children. Data from the Control of Myopia Using Peripheral Diffusion Lenses: Efficacy and Safety Study (CYPRESS, NCT03623074) clinical trial showed that both test arms demonstrated a reduction in myopia progression as assessed by the co-primary outcome measures of axial length and cycloplegic spherical equivalent refraction (SER) change at 12 months.
CYPRESS 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 lenses. The primary outcome measure is the progression of myopia, as defined by a change in axial length and change in cycloplegic SER, over 36 months.
“The topline results from the planned one-year analysis of our pivotal CYPRESS clinical study evaluating our innovative spectacle lenses to reduce the progression of myopia in children showed superiority of both test arms compared to control lenses. These findings are highly encouraging. We look forward to additional data from the ongoing trial, and sharing more information about these 12-month data in the near future,” said Joe Rappon, OD, MS, FAAO, Chief Medical Officer.
Data from this 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.
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.