SightGlass Vision announced positive 12-month results for its innovative myopia-slowing spectacle lenses.
The Control of myopia using peripheral diffusion lenses: efficacy and safety study (Cypress) interim data demonstrated a reduction in myopia progression, assessed by the co-primary outcome measures of axial length and cycloplegic spherical equivalent refraction (SER) change, at 12 months, said the company.
The findings are very encouraging, said SightGlass’ chief medical officer Joe Rappon. "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.”
Cypress, a prospective, multi-centre, subject- and observer-masked, randomised, controlled pivotal clinical study, includes 256 children aged six-to-10 years old across 14 trial sites in the US and Canada. At the time of enrolment, 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 progression of myopia, as defined by change in axial length and change in cycloplegic SER, over 36 months.
A 24-month interim data analysis is planned for next year.
