Staar Surgical Announces FDA Approval of its Implantable Collamer Lenses
Staar Surgical Co. today announced that the FDA has granted approval for the Visian EVO/EVO+ (“EVO”) implantable collameric lens for the correction of myopia and myopia with astigmatism. Myopia, also known as nearsightedness or need for distance vision correction, is the most common vision disorder in the world and its prevalence is increasing rapidly.1
An estimated 100 million American adults between the ages of 21 and 45 with myopia are potential candidates for EVO, a biocompatible implantable lens that corrects distance vision.2
“Following FDA approval, prospective patients in the United States and their physicians can now consider EVO to achieve visual freedom from the limitations, ongoing maintenance, and inconvenience associated with eyeglasses and contact lenses” , said Caren Mason, President and CEO of STAAR Surgical. declaration
Mason noted that more than one million EVO lenses have already been implanted by doctors outside the United States and 99.4% of EVO patients in a survey said they would have the procedure again.3 The EVO lens is additive, provides excellent quality day and night vision, does not cause dry eye syndrome, and can be removed by a physician if ever desired.4,5,6
“Sales of EVO lenses outside of the U.S. grew 51% in 2021 and more than doubled since 2018, a testament to the growing choice of patients and our partner surgeons for EVO as a premium and primary solution for correction. of refractive vision,” Mason said. “Surgeons will be trained and certified for EVO, and will begin implanting EVO in the coming days and weeks in select cities. Commercialization of EVO in the United States will begin immediately and will be supported by a nationwide advertising, marketing and public relations campaign.
According to the company, STAAR’s EVOs are implanted in the posterior chamber of the eye directly behind the iris and in front of the natural lens. Earlier versions of the Visian ICL lens in the US required pre-operative peripheral iridotomy which is now eliminated with the EVO, maximizing patient comfort and saving time for the surgeon and patient. EVO offers a lens-based alternative for the correction/reduction of refractive error in people who currently use glasses and/or contact lenses for distance vision correction. A multicenter prospective clinical study in the United States has confirmed the safety of the EVO range of myopic lenses.
There are now more than 100 clinical papers available on the safety and effectiveness of the Visian ICL lens family worldwide, according to the company.
Scott D. Barnes, MD, chief medical officer of STAAR Surgical, said in a statement that EVOs are an option for eyeglasses, contact lenses or laser vision correction.
“Today’s announcement is particularly significant as the prevalence of myopia is rapidly increasing and COVID precautions have presented additional challenges for people wearing glasses and/or contact lenses,” he said. declared. “EVO adds an important tool for the eye surgeon looking to improve a patient’s quality of life. Different from LASIK, the EVO lens is added to the patient’s eye through a relatively quick surgical procedure where there is no corneal tissue removal. Additionally, the EVO lens can be removed by a physician if ever desired. The results of our recent clinical trial in the United States are consistent with over one million EVO lenses that have already been implanted worldwide.
The company noted that the EVO Visian ICL (implantable Collamer Lens) is indicated for use in the treatment of phakic eyes in patients 21-45 years of age: for the correction/reduction of myopia in patients with an equivalent spherical ranging from -3.0 D to -20.0 D at the show plane:
- for the correction/reduction of myopic astigmatism in patients with a spherical equivalent ranging from -3.0D to -20.0D with a cylinder of 1.0D to 4.0D at the glasses;
- with an anterior chamber depth (ACD) of 3.00 mm or more, measured from the corneal endothelium to the anterior surface of the lens;
- and a stable refractive history (within 0.5 D for 1 year before implantation).
1 Holden BA, Fricke TR, Wilson DA, et al. Worldwide prevalence of myopia and high myopia and temporal trends from 2000 to 2050. Ophthalmology. 2016.
2 Market scope, refractive surgery report, 2019 and company estimates. The company estimates that more than one in three of the 330 million people in the United States are between the ages of 21 and 45 with myopia greater than -3.0 D and are willing to undergo an EVO procedure, the financial ability to pay for EVO and is relatively close in terms of distance to a board certified surgeon.
3 Packer, The Implantable Collamer Lens with a central port: literature review, Clinical Ophthalmology, 2018.
4 EVO/EVO+ ICL DFU and GDP.
5 Martinez-Plazs E, Lopez-Miguel A, Lopez-De La Rosa A, et al. Effect of EVO+ Visian Phakic implantable Collamer lens on visual performance and quality of vision and life, Am J Ophthalmol 2021;226:117–125.
6 Naves, J. Carracedo, G. Cacho-Babillo, I. Diadenosine Nucleotid Measurements as Dry-Eye Score in Patients After LASIK and ICL Surgery. Presented at the American Society of Cataract and Refractive Surgery (ASCRS) 2012.