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Press Release

 

CONTACT INFORMATION:

Solomon Eye Physicians & Surgeons

Dr. Jonathan Solomon

877-750-6474

[email protected]

 

The Bowie Vision Institute for Applied Sciences announces the U.S. FDA Approval of EVO Visian® Implantable Collamer® Lenses

 

Bowie, Maryland - The Bowie Vision Institute for Applied Sciences announces that its recent clinical trials for STAAR Surgical's EVO/EVO+ Visian® Implantable Collamer® Lens (“EVO”) have contributed to the U.S. Food and Drug Administration’s (FDA) approval of the lens for the correction of myopia and myopia with astigmatism. STAAR’s Implantable Collamer lenses have been improving vision in patients for more than 20 years globally. EVOs are implanted within the posterior chamber of the eye directly behind the iris and in front of the natural crystalline lens. Earlier versions of the Visian ICL lens in the U.S. required a preoperative peripheral iridotomy that is now eliminated with EVO, thereby optimizing patient comfort and time efficiency for both the surgeon and the 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.

 

"My team and I value the opportunity to partner with leading industry manufacturers to bring cutting-edge vision care to our patients," says Dr. Jonathan Solomon, Medical Director of The Bowie Vision Institute for Applied Sciences and Refractive, Cornea & Lens-Implantation Director of Solomon Eye Physicians & Surgeons. "Clinical trials are an important part of the process, and Bowie Vision Institute is committed to conducting this research."

 

As a result of this FDA approval, Solomon Eye Physicians & Surgeons and other vision care providers across the U.S. can offer EVO as a viable option for giving their prospective patients freedom from glasses and contact lenses.

 

EVO Visian® ICL (Implantable Collamer® Lens) is indicated for use in phakic eye treatment in patients 21–45 years of age:

  • for the correction/reduction of myopia in patients with spherical equivalent ranging from -3.0 D to -20.0 D at the spectacle plane;
  • for the correction/reduction of myopic astigmatism in patients with spherical equivalent ranging from -3.0 D to -20.0 D with cylinder of 1.0 D to 4.0 D at the spectacle plane;
  • with an anterior chamber depth (ACD) of 3.00 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens;
  • and a stable refractive history (within 0.5 D for 1 year prior to implantation).

About Bowie Vision Institute

 

The Bowie Vision Institute (BVI) has a simple mission: to provide personalized patient care by offering all treatment options and technologies possible. BVI strives to maintain its involvement with the latest research studies to help test the effectiveness of potential treatments and technologies for patients. The Bowie Vision Institute has participated in several studies in the field of ophthalmology such as:

 

  • OMNI-002; IRB ID #: 5822-003; post- LASIK compounded drug vs. commercial drug
  • SEPS-CXL-001 CIRB Approval Epi-on v Epi-off Corneal Collagen Crosslinking
  • Glaukos, US IDE iStent GC-008
  • TrueVision Advanced 3-D Surgical Guidance
  • Bausch & Lomb, Crystalens –Trulign
  • Abbott Medical Optics, Tecnis Toric 1-Piece IOL Registry
  • Carl Zeiss Meditec, Callisto Surgical Suite
  • Avedro Accelerated-Corneal Collagen Crosslinking

 

About Solomon Eye Physicians & Surgeons

 

Solomon Eye Physicians & Surgeons is a family-oriented ophthalmology practice that provides patients with services ranging from comprehensive eye exams to ocular surgery. Solomon Eye is proud to boast some of the most knowledgeable and extensively trained ophthalmologists and optometrists in the D.M.V. region. Our team includes specialists in LASIK, cataract surgery, refractive lens replacement, Visian ICL, ocular inflammation, dry eye, low vision, family eye care, and more. Each one of our doctors has dedicated his or her career to providing the absolute best in eye care so that our patients can enjoy a crisp, clear view of the world. At Solomon Eye Physicians & Surgeons, our top goals are always to provide the most innovative, effective treatments in an environment where our patients feel comfortable and taken care of. When you visit us for your eye care needs, you can rest assured that our team of board-certified ophthalmologists and optometrists are as invested in achieving your clearest vision and best eye health as you are. Whether you need to schedule your yearly exam or are seeking treatment for an existing eye condition, we have you covered.

 

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.

 

Safe Harbor

 

All statements that are not statements of historical fact are forward-looking statements, including statements about any of the following: any projections (including sales), plans, strategies, and objectives of management for the EVO Visian ICL lens in the U.S. or prospects for achieving such plans, expectations for sales, revenue, the expected impact of the COVID-19 pandemic and related public health measures (including but not limited to its impact on sales), product safety or effectiveness, and any statements of assumptions underlying any of the foregoing, including those relating to the actual or expected market in the U.S. for STAAR’s implantable lenses. 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 Annual Report on Form 10-K for the year ended December 31, 2021, 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 statements 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 or U.S. economic conditions; the impact of the COVID-19 pandemic on markets; the discretion of regulatory agencies to approve or reject existing, new, or improved products, or to require additional actions after approval, or to take enforcement action; international trade disputes; and the willingness of surgeons and patients to adopt a new or improved product and procedure.

 

Important Safety Information for EVO ICL

 

The EVO Visian ICL lens is intended to correct/reduce nearsightedness between -3.0 D up to -20.0 D and treat astigmatism from 1.0 D to 4.0 D. If you have nearsightedness within these ranges, EVO Visian ICL surgery may improve your distance vision without eyeglasses or contact lenses. Because the EVO Visian ICL corrects for distance vision, it does not eliminate the need for reading glasses, you may require them at some point, even if you have never worn them before. Since the implantation of the EVO Visian ICL is a surgical procedure, before considering EVO Visian ICL surgery you should have a complete eye examination and talk with your eye care professional about EVO Visian ICL surgery, especially about the potential benefits, risks, and complications. You should discuss the time needed for healing after surgery. Complications, although rare, may include the need for additional surgical procedures, inflammation, loss of cells from the back surface of the cornea, increase in eye pressure, and cataracts. You should NOT have EVO Visian ICL surgery if your doctor determines that 1) the shape of your eye is not appropriate, 2) you do not meet the minimum endothelial cell density for your age at the time of implantation, 3) you have moderate to severe glaucoma, 4) your vision is not stable, or 5) if you are pregnant or nursing.

 

For additional information regarding clinical trials or consultations for refractive procedures, visit SolomonEye.com