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Glaukos Corporation (NYSE: GKOS) has received 510(k) clearance from the U.S. FDA for its iPRIME™ Viscodelivery System, which is designed for the delivery of viscoelastic fluid during ophthalmic surgery. This sterile, single-use device represents an advancement in minimally invasive glaucoma surgery (MIGS) technology. CEO Thomas Burns highlighted the importance of this clearance in expanding Glaukos' innovative ophthalmic solutions and maintaining their leadership in the MIGS marketplace.
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510(k) clearance from FDA for iPRIME Viscodelivery System enhances Glaukos' product portfolio.
Strengthens Glaukos' position in the minimally invasive glaucoma surgery market.
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None.
SAN CLEMENTE, Calif.--(BUSINESS WIRE)--
Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the iPRIME™ Viscodelivery System, a sterile, single-use, minimally-invasive device for the delivery of viscoelastic fluid during ophthalmic surgery.
“Since the introduction of our first iStent® Trabecular Micro-Bypass Stent in 2012, Glaukos has pioneered the MIGS marketplace and led a transformation in the way ophthalmic surgeons manage chronic eye diseases. We are thrilled to announce this clearance as we believe iPRIME will be another important tool that supports the needs of physicians and patients,” said Thomas Burns, Glaukos president and chief executive officer. “This technology further expands Glaukos’ broad portfolio of innovative ophthalmic solutions and is consistent with our longstanding position on the value of truly minimally-invasive therapy.”
About Glaukos
Glaukos (www.glaukos.com) is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012, its next-generation iStent inject® device in the United States in 2018, and most recently, the iStent inject W device in 2020. In corneal health, Glaukos’ proprietary suite of single-use, bio-activated pharmaceuticals are designed to strengthen, stabilize and reshape the cornea through a process called corneal collagen cross-linking to treat corneal ectatic disorders and correct refractive conditions. Glaukos is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies in glaucoma, corneal health and retinal disease.
Forward-Looking Statements
All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control, that may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this press release. These potential risks and uncertainties include, without limitation, the timing and extent to which we obtain regulatory approval for our investigational products, our ability to successfully commercialize such products, the ability to obtain and maintain adequate financial coverage and reimbursement for our products, and the continued efficacy and safety profile of our products. These and other risks, uncertainties and factors related to Glaukos, and our business are described in detail under the caption “Risk Factors” and elsewhere in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, which was filed with the Securities and Exchange Commission (SEC) on November 8, 2021. Our filings with the Securities and Exchange Commission are available in the Investor Section of our website at www.glaukos.com or at www.sec.gov. In addition, information about the risks and benefits of our products is available on our website at www.glaukos.com. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.
Investor Contact:
Chris Lewis Sr. Director, Investor Relations & Corporate Strategy & Development
(949) 481-0510
clewis@glaukos.com
Source: Glaukos Corporation
FAQ
What is the iPRIME Viscodelivery System by Glaukos?
The iPRIME Viscodelivery System is a sterile, single-use device that delivers viscoelastic fluid during ophthalmic surgery, recently cleared by the U.S. FDA.
What recent approval did Glaukos Corporation receive?
Glaukos Corporation received 510(k) clearance from the U.S. FDA for the iPRIME Viscodelivery System.
How does the iPRIME System impact glaucoma surgery?
The iPRIME System enhances the options available for ophthalmic surgeons in the treatment of glaucoma, supporting minimally invasive procedures.
What is Glaukos Corporation's focus in the market?
Glaukos Corporation focuses on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
