Study Met Primary Efficacy Endpoint, Demonstrating Statistically Significant Superiority and Clinically Meaningful IOP Reduction vs. Cataract Surgery Alone
iDose TR in Combination with Cataract Surgery Demonstrated Robust Mean IOP Reduction of 11.1 mmHg and Favorable Safety Profile Through 3 Months
ALISO VIEJO, Calif.--(BUSINESS WIRE)--Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases, today announced positive topline results from the Phase 4 prospective, randomized, controlled clinical trial (GLK-101-04) evaluating iDose® TR administered in conjunction with cataract surgery compared to cataract surgery alone in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
The study achieved its primary efficacy endpoint, with iDose TR demonstrating statistically significant superiority in the reduction of mean diurnal intraocular pressure (IOP) when administered in conjunction with cataract surgery compared to cataract surgery alone. At month 3, subjects undergoing cataract surgery and administration of iDose TR achieved a mean diurnal IOP reduction of 11.1 mmHg from baseline, compared to 7.4 mmHg for subjects undergoing cataract surgery alone, demonstrating statistically significant superiority with a clinically meaningful incremental treatment effect of 3.6 mmHg (p<0.0001). In addition, iDose TR demonstrated statistically significant superiority across all pre-specified secondary responder analyses, further supporting the consistency and robustness of the treatment effect observed in the study.
iDose TR also demonstrated a favorable safety profile through 3 months, with no treated-related adverse events of corneal endothelial cell loss or cystoid macular edema (CME), and no serious corneal adverse events. Overall safety findings were consistent with the well-established safety profile of iDose TR and previous clinical experience.
“We are pleased to announce these positive Phase 4 results, which add to the extensive body of clinical evidence supporting the efficacy, durability, and safety of iDose TR,” said Thomas Burns, Glaukos chairman and chief executive officer. “Importantly, these data further reinforce the versatility of iDose TR across various administration settings, demonstrating its ability to deliver clinically meaningful robust IOP reduction whether administered as a standalone procedure or in conjunction with cataract surgery. iDose TR continues to deliver strong clinical outcomes that provide meaningful benefits for patients, helping to accelerate a broader treatment paradigm shift toward earlier, interventional glaucoma care.”
GLK-101-04 is a Phase 4, prospective, multicenter, randomized, double-masked, parallel-group clinical trial evaluating the efficacy and safety of iDose TR in combination with cataract surgery compared to cataract surgery alone in adults with OAG or OHT. The study randomized 149 study eyes, with 74 eyes assigned to the iDose TR in combination with cataract surgery arm and 75 eyes assigned to the cataract surgery alone arm. The primary endpoint evaluated the change from baseline in mean diurnal IOP at month 3.
iDose TR is a first-of-its-kind, long-duration, intracameral procedural pharmaceutical therapy designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for up to three years. iDose TR is intended to improve the standard of care by addressing the ubiquitous patient non-compliance issues and chronic side effects associated with topical glaucoma medications.
For more information about iDose TR and Full Prescribing Information, please visit www.iDoseTRhcp.com.
About Glaukos
Glaukos (www.glaukos.com) is an ophthalmic pharmaceutical and medical technology 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. In 2024, Glaukos commenced commercial launch activities for iDose® TR, a first-of-its-kind, long-duration, intracameral procedural pharmaceutical designed to deliver 24/7 glaucoma drug therapy inside the eye for extended periods of time. Glaukos also markets the only FDA-approved corneal cross-linking therapy utilizing a proprietary bio-activated pharmaceutical for the treatment of keratoconus, a rarely diagnosed corneal disorder. Glaukos continues to successfully develop and advance a robust pipeline of novel, dropless platform technologies designed to meaningfully advance the standard of care and improve outcomes for patients suffering from chronic eye diseases.
About iDose TR (U.S.)
iDose TR (travoprost intracameral implant) is a long duration prostaglandin analog approved for a single administration and indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Made from medical-grade titanium, iDose TR is implanted through the trabecular meshwork and back wall of Schlemm's canal, directly into scleral tissue. Once implanted, 75 mcg of a novel, preservative-free, proprietary formulation of travoprost continuously elutes into the anterior chamber via membrane-controlled diffusion, allowing for 24/7 release of medication.
Indication for Use: iDose TR (travoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
Dosage and Administration: For ophthalmic intracameral administration. The intracameral administration should be carried out under standard aseptic conditions.
Contraindications: iDose TR is contraindicated in patients with active or suspected ocular or periocular infections, patients with corneal endothelial cell dystrophy (e.g., Fuch’s Dystrophy, corneal guttatae), patients with prior corneal transplantation, or endothelial cell transplants (e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [DSAEK]), patients with hypersensitivity to travoprost or to any other components of the product.
Warnings and Precautions: iDose TR should be used with caution in patients with narrow angles or other angle abnormalities. Monitor patients routinely to confirm the location of the iDose TR at the site of administration. Increased pigmentation of the iris can occur. Iris pigmentation is likely to be permanent.
Adverse Reactions: In controlled studies, the most common ocular adverse reactions reported in 2% to 6% of patients were increases in intraocular pressure, iritis, dry eye, visual field defects, eye pain, ocular hyperaemia, and reduced visual acuity.
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, our ability to successfully commercialize our iDose TR, the timing and extent to which obtain regulatory approval for 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 as might be suggested in this Phase 4 clinical trial. 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 June 30, 2026, which was filed with the SEC on July 29, 2026. 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.
Contacts
Investor Contact:
Chris Lewis
Vice President, Investor Relations & Corporate Affairs
clewis@glaukos.com
Media Contact:
Silvana Guerci-Lena
(508) 808-8993
GlaukosMedia@powers-co.com
