Staar Surgical Announces Submission of Presbyopia Clinical Trial Data
Staar Surgical announced the submission of its multisite European pivotal clinical trial data for the EVO+ Visian ICL with Aspheric (EDOF) Optic, a lens that is designed to provide correction or reduction of myopia or hyperopia and presbyopia. Results from the clinical trial were submitted to DEKRA, the company’s European Notified Body, earlier this month. If approved, Staar’s EDOF lens could be commercially available in countries recognizing the CE Mark in the second quarter of 2020.
“Our team is pleased to announce our EDOF lens for presbyopia met the primary performance endpoint of our multisite European pivotal clinical trial and that we have recently submitted the data to our Notified Body for review,” Caren Mason, President and CEO of Staar Surgical, said in a company news release. “The trial data confirms our Extended Depth of Focus (EDOF) lens can provide improved visual acuity for patients at near, intermediate and far distances. We believe our EDOF Collamer lenses provide a bilateral treatment for presbyopic patients enabling true binocular vision at near, intermediate and far distances. This can represent an attractive solution among refractive options currently available in the market today that require either corneal tissue reshaping or removal of one’s healthy crystalline lens. If approved, we believe our EDOF lens will further extend the renaissance of Staar’s EVO family of lenses and encourage broader use of the entire EVO family of lenses in the 31+ countries that recognize the CE Mark.”
The multicenter European study evaluated the clinical performance of Staar’s phakic IOL, Staar EVO+ Visian ICL with Aspheric (EDOF) Optic for the improvement of uncorrected near visual acuity (UCNVA) in subjects who require between +1.00 and +2.50 Reading Add.
The primary performance endpoint for the trial, which Staar accomplished, was defined as achievement of monocular UCNVA of 20/40 or better at 40 cm (approximately 16 inches) at 6 months after implantation in equal to or greater than 75% of implanted eyes. 20/40 generally represents a level of near vision, such as reading a newspaper, that does not require spectacles.
EVO Visian Implantable Collamer Lenses (ICLs) are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction/reduction of refractive error in those who currently utilize spectacles and/or contact lenses for vision correction.
Additional information on Staar’s presbyopia clinical trial is available with ClinicalTrials.gov Identifier: NCT03499821 at http://www.clinicaltrials.gov.