Glaukos Announces Commencement of Phase 2 Corneal Health Clinical Program for Third-Generation iLink™ Therapy

Rhea-AI Summary

Glaukos Corporation (NYSE: GKOS) has announced the initiation of a Phase 2 clinical program for its third-generation iLink™ therapy aimed at treating keratoconus. This innovative therapy utilizes a proprietary system to deliver ultraviolet light for corneal cross-linking, enhancing the strength and shape of the cornea. The Phase 2 study will involve two multi-center, randomized, controlled trials to assess customized versus non-customized treatment patterns and a new bio-activation system. Patient enrollment will occur across the United States, Europe, South America, and Asia, with a follow-up period of six months.

Positive

• Commencement of Phase 2 clinical program for third-generation iLink therapy.
• Focus on customization in treatment patterns for keratoconus patients.
• Enrollment expected across multiple global regions, enhancing data diversity.

Negative

• Success of clinical trials and regulatory approvals remains uncertain.
• Potential risks and uncertainties noted regarding the efficacy and safety of iLink therapies.

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 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.

About Glaukos

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.

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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220314005295/en/

Media Contact:

Michele Gray

(917) 449-9250

michele@mgraycommunications.com

Investor Contact:

Chris Lewis

Vice President, Investor Relations & Corporate Affairs

(949) 481-0510

clewis@glaukos.com

Source: Glaukos Corporation

FAQ

What is the purpose of Glaukos' Phase 2 clinical program for iLink therapy?

The Phase 2 clinical program aims to evaluate the safety and efficacy of customized versus non-customized treatment patterns for keratoconus using third-generation iLink therapy.

When does the Phase 2 clinical program for GKOS's iLink therapy start?

Glaukos has commenced the Phase 2 clinical program for its third-generation iLink therapy, as announced in the recent press release.

What regions will participate in the clinical trials for GKOS's iLink therapy?

The trials will enroll patients across the United States, Europe, South America, and Asia.

What are the expected outcomes of the Phase 2 trials for GKOS?

The trials aim to assess the safety and efficacy of new customized treatment patterns and a novel laser-based bio-activation system.

What are potential risks associated with GKOS's iLink therapy?

There are uncertainties regarding the successful outcomes of clinical trials and obtaining regulatory approvals for the iLink therapies.