Glaukos Submits New Drug Application to U.S. FDA for iDose TR

Rhea-AI Summary

Glaukos Corporation (NYSE: GKOS) announced the submission of its New Drug Application (NDA) for iDose TR to the U.S. FDA. This micro-invasive implant aims to deliver therapeutic levels of travoprost, improving patient compliance and reducing side effects of traditional glaucoma treatments. The NDA includes data from two successful Phase 3 trials confirming efficacy and safety over 12 months. CEO Thomas Burns highlighted this submission as a significant milestone, emphasizing the potential of iDose TR as a transformative therapy for glaucoma patients. The company aims to work closely with the FDA during the review process.

Positive

• Submission of New Drug Application for iDose TR indicates progress in glaucoma treatment innovation.
• Data from two Phase 3 pivotal trials demonstrated successful primary efficacy endpoints.
• iDose TR offers a long-term dropless alternative to traditional glaucoma treatments.

Negative

• None.

ALISO VIEJO, 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 the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for iDose^® TR. iDose TR is a micro-invasive intraocular implant designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost from within the eye for extended periods of time. iDose TR is intended to address ubiquitous patient non-compliance and chronic side effects associated with topical glaucoma medications.

“The submission of the iDose TR NDA represents a significant milestone for our company, resulting from more than a decade of our teams’ unrelenting research, development and clinical efforts to bring this potential game-changing therapy one step closer to patients who may need a new glaucoma treatment alternative,” said Thomas Burns, Glaukos chairman and chief executive officer. “We look forward to working closely with the FDA in their pending review process and continue to believe iDose TR can be a transformative novel technology able to fundamentally improve the treatment paradigm for patients with glaucoma.”

The NDA submission includes data from two Phase 3 pivotal trials of iDose TR, which both successfully achieved the pre-specified primary efficacy endpoints through 3 months and demonstrated a favorable tolerability and safety profile through 12 months. In addition, the submission also includes data from the iDose TR exchange trial, which included a second administration of iDose TR and removal of the original iDose TR, with the second iDose TR administration demonstrating a favorable safety profile over a 12-month evaluation period.

Administered during a micro-invasive procedure, the iDose TR contains a novel formulation of travoprost, a prostaglandin analog used to lower intraocular pressure. The iDose TR is designed such that it can be removed and replaced with a new iDose TR, thus potentially offering a long-term dropless alternative to daily eye drop treatment.

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 continues to develop 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 obtain regulatory approval for investigational products such as iDose TR, our ability to successfully commercialize such products, the ability to obtain and maintain adequate financial coverage and reimbursement for this product, and the continued efficacy and safety profile of this product as reported in the pivotal trials and other clinical studies. 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, 2022, which was filed with the Securities and Exchange Commission (SEC) on February 24, 2023. 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/20230227005146/en/

Media Contact:

Cassandra Dump

(619) 971-1887

Cassy.dump@precisionvh.com

Investor Contact:

Chris Lewis

Vice President, Investor Relations & Corporate Affairs

(949) 481-0510

clewis@glaukos.com

Source: Glaukos Corporation

FAQ

What is the significance of the NDA submission by Glaukos Corporation for iDose TR?

The NDA submission represents a major advancement in glaucoma treatment, aiming to provide a more effective and compliant solution for patients.

What are the key features of the iDose TR implant?

iDose TR is designed to deliver therapeutic levels of travoprost continuously, addressing patient non-compliance associated with daily eye drops.

What were the results of the Phase 3 trials for iDose TR?

The Phase 3 trials successfully met primary efficacy endpoints and demonstrated a favorable safety profile for up to 12 months.

When was the NDA for iDose TR submitted to the FDA?

The NDA for iDose TR was submitted to the U.S. FDA as announced in the recent press release by Glaukos Corporation.