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 commenced a Phase 2 clinical program for its third-generation iLink™ therapy designed to treat keratoconus.
Glaukos’ iLink pharmaceutical platform consists of novel single-use drug formulations that are bio-activated by proprietary systems through the delivery of ultraviolet light to the cornea to induce a reaction called corneal cross-linking designed to strengthen, stabilize and reshape the cornea. Glaukos’ third-generation iLink therapy is a corneal cross-linking treatment designed to customize the therapeutic capabilities, streamline the patient experience and build upon Glaukos’ first-generation iLink therapy, known as iLink Epi-off™, and its second-generation iLink investigational therapy, known as iLink Epi-on™.
“As we do with all of our platforms, we continue to drive subsequent generations of future innovation, and we are delighted to announce the commencement of this Phase 2 clinical program for our third-generation iLink therapy,” said Thomas Burns, Glaukos president and chief executive officer. “Our third-generation iLink therapy builds upon our proven iLink platform therapies and we are delighted to have the opportunity to explore what this promising investigational therapy can do for keratoconus patients in our Phase 2 trials.”
The third-generation iLink Phase 2 clinical program consists of two separate multi-center, randomized, controlled trials designed to evaluate the safety and efficacy of patient-specific, customized versus non-customized treatment patterns for corneal cross-linking and a new investigational laser-based bio-activation system, respectively. The company anticipates it will enroll keratoconus patients across both trials at clinical sites in the United States, Europe, South America and Asia. Both trials are designed to have a primary safety and efficacy follow-up period of 6 months.
Glaukos (www.glaukos.com) is an ophthalmic medical technology and pharmaceutical company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012, and has since developed a portfolio of technologically distinct and leverageable platforms to support ongoing pharmaceutical and medical device innovations. Products or product candidates for each of these platforms are designed to advance the standard of care through better treatment options across the areas of glaucoma, corneal disorders and retinal diseases.
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 are successful in our clinical trials evaluating the safety and efficacy of iLink therapies, the extent to which we may obtain regulatory approval for our iLink therapies or other 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 Annual Report on Form 10-K for the year ended December 31, 2021, which was filed with the Securities and Exchange Commission (SEC) on February 28, 2022. Our filings with the SEC 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.