After years of seeking FDA approval for its implanted vision-correcting lens, Staar Surgical has successfully reached a regulatory milestone. The Evo/Evo+ Visian implanted collamer lens is designed to treat myopia (nearsightedness) with or without astigmatism and is an alternative to other vision correction options such as glasses or contacts.
Staar first applied for FDA review in 2019 but was given a denial early that year. In August 2019, the FDA approved a clinical study of the lens. Premarket has been approved, and the device has already been implanted in more than one million patients in more than 75 countries outside of the United States.
Roughly one-third of the United States population (100 million people) between the ages of 21 and 45 who have myopia over -3.0D could be eligible to receive the device.
The Evo device is implanted between the iris and the crystalline lens in the posterior eye chamber, making it a swift procedure that does not require a preoperative peripheral iridotomy, where a laser is used to create a hole in the iris.
Unlike LASIK surgery, Evo/Evo+ does not require the removal of corneal tissue and is removable by a doctor if necessary. Since myopia is becoming more common, the newly FDA-approved solution to vision loss is necessary. Forecasts imply almost half of the world’s population could be nearsighted by 2050.
Staar has been in the ophthalmic surgery field for more than 30 years, as they design, develop, manufacture, and market implantable lenses for the eye.
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Rohr Eye & Laser Center offers the most advanced technology available to provide personalized and extraordinary care to our patients. Whether your goal is to maintain or improve your natural vision, we are here to help you. Call us at 877-579-0202 or visit https://www.michiganlasik.com/ to schedule an appointment today.
Written by the digital marketing team at Creative Programs & Systems: www.cpsmi.com.