07.07.20

STAAR Surgical’s EVO Viva Presbyopia Correcting Lens Receives CE Mark Approval

Source: STAAR Surgical

STAAR Surgical announced that its EVO Viva presbyopia correcting implantable collamer lens (ICL) has been approved for sale. STAAR received CE Mark approval of the presbyopic indication for its EVO+ Visian ICL with Aspheric (EDOF) Optic, commercially marketed as “EVO Viva,” from its European Notified Body, DEKRA, on July 2, 2020.

EVO Viva will initially be available to patients through select eye doctors in Spain, Germany and Belgium. Broader availability of the lens will follow in Europe and other markets recognizing the CE Mark over the coming months.

“The launch of EVO Viva significantly expands the market opportunity for our EVO family of lenses to now include lenses for patients suffering from presbyopia in the over 30 countries that currently recognize the CE Mark,” Caren Mason, President and CEO of STAAR Surgical, said in a company news release. “EVO Viva is a new treatment option for potential future consideration by the 1.7 billion people globally with presbyopia who may be burdened by reading glasses or frequent replacement contact lenses. EVO Viva reinforces our deep commitment to patients seeking visual freedom who have the express desire to get rid of their reading glasses. We believe EVO Viva can represent an attractive alternative among refractive surgery options currently available in the market today that require either ablating corneal tissue or removal of one’s healthy crystalline lens. EVO Viva further extends the renaissance of STAAR’s EVO family of lenses and encourages broader use of the entire EVO family of lenses.”

More than 1,000,000 ICLs have been implanted by surgeons with patient satisfaction reported at 99.4%. ICL’s are implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsular bag. ICLs offer an intraocular alternative for the correction/reduction of refractive error in those who currently use spectacles and/or contact lenses for vision correction.

EVO Viva is STAAR’s next-generation implantable collamer lens. The lens is designed to work in harmony with a patient’s eye for the correction or reduction of myopia and presbyopia in phakic and pseudo-phakic (post-cataract IOL) eyes to correct vision. The EVO Viva lens adds near and intermediate vision correction for patients with presbyopia.

A multicenter, prospective clinical investigation demonstrated the ability of the EVO Viva lens to correct myopia and presbyopia, resulting in improvement of uncorrected near, intermediate and distance visual acuity without compromising quality of vision. Subjects reported significant improvements in quality of life and high levels of spectacle independence and satisfaction. A clinical paper authored by the Medical Monitor and Principle Investigators from the study is being submitted for publication.

The Directions for Use (DFU) lists the indications as: EVO Viva ICL (Implantable Collamer Lens) with Aspheric (EDOF) Optic is indicated for use in phakic eye treatment in patients 21– 60 years of age and pseudophakic eye treatment in patients with monofocal IOLs with and without cylinder correction 21 years of age and older for:

  • The correction/reduction of myopia in patients ranging from -0.5 D to -20.0 D at the spectacle plane.
  • The correction/reduction of myopia with presbyopia in patients ranging from -0.5 D to -20.0 D at the spectacle plane.
    • For extended depth of focus and improved near visual acuity.
  • With an anterior chamber depth (ACD) equal to or greater than 2.8 mm as measured from the corneal endothelium to the anterior lens capsule.

 

Related Content