STAAR Surgical Company (STAA) - Get Report, a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, today announced the initial commercialization of its EVO Viva™ presbyopia correcting lens including the first patient implant.
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Erik L. Mertens, MD, FEBOphth, Medical Director and Eye Surgeon, Mediopolis, Antwerp Private Clinic, Holds a Packaged EVO Viva™ lens kit. (Photo: Business Wire)
"The first patient received his EVO Viva lenses on October 23 in Belgium from Dr. Erik Mertens, and we are delighted to hear from Dr. Mertens that the patient is quite happy with his lenses," stated Caren Mason, President and CEO of STAAR Surgical. "Our presbyopia-correcting EVO Viva lens is aimed at patients in their 40s and 50s who struggle with near vision and the burdens associated with wearing reading glasses. EVO Viva consumer websites are now live in multiple languages, the first clinical paper has been published and a video clinical summary is now available."
Erik Mertens, MD, Medical Director and Eye Surgeon, Mediopolis, stated, "My experience during the international study and the first worldwide implantation of the commercially available EVO Viva ICL made me realize how important it is to make patients very happy when they get rid of reading glasses. Not being able to read up close makes people realize they're getting older and this frustrates them enormously. With the EVO Viva ICL, I can rejuvenate the eye without changing the integrity of it because the crystalline lens and the cornea are preserved. If in the future an alternative procedure is needed the EVO Viva ICL can be easily removed without any drawbacks. This innovative procedure will definitely change the way eye surgeons treat presbyopia in the near future."
French, Dutch and Spanish language EVO Viva consumer websites are now live. Additional local language websites will be rolled out in the coming months. The websites have been designed to evoke memories of a time when the patient's vision was clear - prior to presbyopia blurring near vision. The nostalgic lookback is supported by the EVO Viva " Rewind Your Vision" and "See Young Again!" primary messaging. Visitors to the EVO Viva websites can learn more about product benefits by browsing various pages, including Life with Viva, Why Viva, Procedures and FAQs. The EVO Viva websites include STAAR's latest Doc Finder with images of clinics and doctors.
Principal investigating surgeons and Dr. Mark Packer have published the first clinical paper discussing the EVO Viva clinical data in the peer-reviewed journal, Clinical Ophthalmology. The paper outlines the improvements in uncorrected near, intermediate and distance visual acuity for patients who desire spectacle independence. The average age of patients in the trial was 49 with patients who required between 1.00 and 2.50 diopters of reading add with an average of 1.66 diopters. Patients were bilaterally implanted with emmetropia targeted in all eyes. Objective measures of visual acuity, contrast sensitivity and defocus curves were measured as well as patient reported outcomes to understand how patients feel about their experience. The paper concludes that contrast sensitivity was preserved with the EVO Viva lens and that patients demonstrated a high level of satisfaction, improved QoL, and spectacle independence.
Ms. Mason added, "In the coming months we will work closely with a select group of implanting surgeons to develop an EVO Viva playbook of best practices. The playbook, which we expect to broadly introduce to EVO surgeons at our Experts Summit ahead of the 39 th Congress of the European Society of Cataract and Refractive Surgeons in Barcelona in September 2021, will be squarely focused on helping clinicians properly add the Viva lens to their current armamentarium and optimize the objective and subjective factors that will delight patients."
The EVO Viva ™ lens is a new treatment option for potential future consideration by the 1.7 billion people globally with presbyopia who want to get rid of their reading glasses. The lens is intended to give a continuous range of focus from near, through intermediate and to far distance.
1 Fricke, Fricke, Global Prevalence of Presbyopia and Vision Impairment from Uncorrected Presbyopia, 2018.
About STAAR Surgical
STAAR, which has been dedicated solely to ophthalmic surgery for over 30 years, designs, develops, manufactures and markets implantable lenses for the eye with companion delivery systems. These lenses are intended to provide visual freedom for patients, lessening or eliminating the reliance on glasses or contact lenses. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. STAAR's lens used in refractive surgery is called an Implantable Collamer® Lens or "ICL," which includes the EVO Visian ICL™ product line. More than 1,000,000 Visian ® ICLs have been implanted to date and STAAR markets these lenses in over 75 countries. To learn more about the ICL go to: www.discovericl.com. Headquartered in Lake Forest, CA, the company operates manufacturing and packaging facilities in Aliso Viejo, CA; Monrovia, CA; and Nidau, Switzerland. For more information, please visit the Company's website at www.staar.com.
All statements that are not statements of historical fact are forward-looking statements, including statements about any of the following: any financial projections, expectations for sales, revenue, or earnings relating to the EVO Viva family of lenses, and any statements of assumptions underlying any of the foregoing, including those relating to product launch, product success/market adoption, and market expansion activities. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include risks and uncertainties related to the COVID-19 pandemic and related public health measures, as well as the factors set forth in the Company's Quarterly Report on Form 10-Q for the quarter ended April 3, 2020, and Annual Report on Form 10-K for the year ended January 3, 2020 under the caption "Risk Factors," which is on file with the Securities and Exchange Commission and available in the "Investor Information" section of the company's website under the heading "SEC Filings." We disclaim any intention or obligation to update or revise any financial projections or forward-looking statement due to new information or events. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties include the following: global economic conditions; and the willingness of surgeons and patients to adopt a new or improved product and procedure such as the EVO Viva lens. The EVO and EVO Viva versions of our ICL lens are not yet approved for sale in the United States.
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