PALO ALTO, Calif., Oct. 24, 2019 /PRNewswire/ -- SightGlass Vision, Inc., a medical device company developing spectacle lenses to slow the progression of nearsightedness or myopia in children, today announced that data from three clinical trials overviewing discovery to clinical development of its novel spectacle lenses will be presented for the first time in a scientific forum at the 3rd World Congress of Optometry (WCO19) and Academy 2019 (Academy19), held October 23 to 27, 2019 in Orlando, Florida ("A Novel Spectacle Lens for Myopia Management: From Discovery to Clinical Development" poster session on Sunday, October 27, 2019, Poster 28, Exhibit Hall WE2).
In addition to the explanation about how a genetic discovery led to the hypothesis that contrast signaling in the retina may play a role in myopia development, the Company will present data from the following three key studies:
- PALM was an initial pilot study in children aged eight-to-13 with progressive myopia. One eye was fitted with a SightGlass lens and the fellow eye was fitted with a control single vision lens. The SightGlass lens was well tolerated and resulted in significantly less progression, as measured by axial length change, compared to the control eye;
- WALNUT demonstrated tolerability of three optimized spectacle lens designs. Of note, all three lens designs showed a trend toward reduction in axial length over the two weeks of lens wear, with one design reaching statistical significance in both eyes (p<0.05); and,
- CYPRESS is an ongoing, multi-center, double-masked, randomized controlled pivotal clinical study in children aged six-to-10 years old and having myopia between -0.75 D and -4.5 D (spherical equivalent refraction) at the time of enrollment. Data from this trial will be used to support registration and market launch of the Company's novel lenses. The 12-month results from CYPRESS will be available in Q2 2020.
"We are excited to share for the first time with the medical community the story of our novel spectacle lenses designed to manage myopia in children – from concept to the clinic. We look forward to reporting the planned, one-year results from our pivotal trial, CYPRESS, in Q2 2020, followed by additional data with longer-term follow up," said Joe Rappon, OD, MS, FAAO, Chief Medical Officer.
Myopia – a Problem of Global Epidemic Proportions
Nearsightedness or myopia is a condition that occurs when the light coming into an eye doesn't 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.
There are currently no FDA-approved treatments to slow or prevent the progression of myopia. Glasses and contact lenses currently available in the U.S. only correct myopia, but do not help prevent it from getting worse. Early intervention is key to preventing high myopia from developing.
About the CYPRESS and WALNUT Trials
CYPRESS (NCT03623074) is a multicenter, double-blinded, randomized, controlled clinical trial that enrolled and dispensed lenses to 256 patients aged six-to-10 years old across 14 clinical sites in the U.S. and Canada. The primary outcome measure is progression of myopia (change in axial length and change in spherical equivalent refraction) over 36 months. Trial participants are using one of three types of lenses instead of their normal glasses.
WALNUT (NCT03761758) was the Company's prospective, randomized, subject-masked, three-arm clinical study of 21 healthy myopic (-1.00 to -4.00 DS) children aged six-to-12 years old who were habitual spectacle wearers. Study participants were randomized to one of three lens designs for two weeks. Lenses were designed to modulate contrast in the periphery of the visual field at three different levels. The primary outcome variables were distance visual acuity, contrast sensitivity, and subjective responses of acceptability assessed using a questionnaire. Other outcome variables included a parent questionnaire, near visual acuity, and axial length measurements.
Visit www.clinicaltrials.gov for more information about CYPRESS and WALNUT.
About SightGlass Vision, Inc.
SightGlass Vision, Inc. is a clinical-stage medtech startup 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.
SOURCE SightGlass Vision, Inc.