Glaukos Reports Positive Phase 4 Results for iDose TR Combined With Cataract Surgery in Glaucoma Patients
Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company developing innovative treatments for glaucoma, corneal disorders, and retinal diseases, has announced positive topline results from its Phase 4 clinical trial evaluating iDose® TR in combination with cataract surgery. The study, designated GLK-101-04, compared the efficacy and safety of iDose TR administered alongside cataract surgery with cataract surgery alone in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
The trial achieved its primary efficacy endpoint, demonstrating statistically significant superiority for the combination of iDose TR and cataract surgery in reducing mean diurnal intraocular pressure (IOP) compared with cataract surgery alone. At three months, patients receiving iDose TR alongside cataract surgery experienced a mean diurnal IOP reduction of 11.1 mmHg from baseline, compared with a reduction of 7.4 mmHg among patients who underwent cataract surgery alone. The resulting incremental treatment effect was 3.6 mmHg, with a p-value of less than 0.0001.
These findings indicate that adding iDose TR to cataract surgery can provide an additional reduction in intraocular pressure beyond the reduction achieved through cataract surgery alone. The results also support the potential role of the therapy in expanding treatment options for patients managing glaucoma or elevated eye pressure while undergoing cataract surgery.
In addition to meeting its primary endpoint, iDose TR demonstrated statistically significant superiority across all prespecified secondary responder analyses. According to Glaukos, these findings further reinforce the consistency of the treatment effect observed in the study and add to the clinical evidence supporting the therapy’s efficacy.
The company also reported a favorable safety profile through three months of follow-up. No treatment-related cases of corneal endothelial cell loss or cystoid macular edema (CME) were reported, and no serious corneal adverse events were observed. Overall safety findings were consistent with the established safety profile of iDose TR and previous clinical experience.
The positive results represent another clinical milestone for Glaukos as it continues to investigate the use of sustained-release pharmaceutical therapies in glaucoma management, including their potential application during other ophthalmic procedures.
Phase 4 Study Demonstrates Significant Intraocular Pressure Reduction
The GLK-101-04 trial was designed to evaluate whether administering iDose TR during cataract surgery could provide additional IOP-lowering benefits compared with cataract surgery alone. The study was conducted as a prospective, multicenter, randomized, double-masked, parallel-group clinical trial involving adults diagnosed with open-angle glaucoma or ocular hypertension.
A total of 149 study eyes were randomized between the two treatment groups. Of these, 74 eyes were assigned to receive iDose TR in combination with cataract surgery, while 75 eyes were assigned to undergo cataract surgery alone.
The primary endpoint measured the change from baseline in mean diurnal IOP at Month 3. Mean diurnal IOP reflects intraocular pressure measurements collected at different times during the day, providing a broader assessment of pressure levels than a single measurement.
Elevated intraocular pressure is an important risk factor in glaucoma, a group of eye diseases that can damage the optic nerve and lead to progressive vision loss. Lowering IOP is a central component of glaucoma management because reducing pressure can help limit the risk of further damage.
The trial results showed a greater reduction in mean diurnal IOP among patients treated with iDose TR alongside cataract surgery than among those who received cataract surgery alone.
At Month 3, the combination group achieved a mean reduction of 11.1 mmHg from baseline. The cataract surgery-alone group experienced a mean reduction of 7.4 mmHg. The difference between the groups represented an incremental treatment effect of 3.6 mmHg, with statistically significant superiority for iDose TR combined with cataract surgery at p less than 0.0001.
The statistical significance of the findings indicates that the observed difference between the treatment groups is unlikely to be attributable to chance alone under the study’s statistical framework. The magnitude of the difference also provides evidence of an additional IOP-lowering effect associated with the use of iDose TR in this setting.
Although cataract surgery can itself influence intraocular pressure, the results suggest that the addition of iDose TR can provide further pressure reduction in appropriately selected patients with OAG or OHT.
The findings may be particularly relevant for patients who require cataract surgery and also need ongoing management of elevated eye pressure. Combining treatments within a single surgical setting could offer an additional opportunity to address both conditions as part of an individualized ophthalmic care plan.
Secondary Analyses Support Consistency of Treatment Benefits
Beyond the primary endpoint, iDose TR demonstrated statistically significant superiority across all prespecified secondary responder analyses.
Responder analyses assess the proportion of patients who achieve defined treatment outcomes, such as specified reductions in intraocular pressure. These analyses can provide additional information about how consistently a treatment performs across a clinical study population.
Glaukos reported that the secondary analyses supported the robustness of the treatment effect observed in GLK-101-04. Together with the primary efficacy findings, these results strengthen the evidence that iDose TR can provide additional IOP reduction when administered alongside cataract surgery.
The company has positioned the findings within its broader clinical development program, which evaluates iDose TR across different treatment settings. The latest data support the potential versatility of the therapy, including its use as part of a cataract surgery procedure rather than exclusively as a standalone intervention.
Further follow-up and additional clinical evidence will remain important for understanding the duration of the treatment effect, longer-term safety, and the role of iDose TR in different patient populations and procedural settings.
Nevertheless, achieving the primary endpoint and demonstrating consistent results across the prespecified secondary responder analyses represent important outcomes for the Phase 4 program.
Favorable Safety Profile Observed Through Three Months
Safety was another important component of the GLK-101-04 study. Glaukos reported that iDose TR demonstrated a favorable safety profile through the three-month evaluation period, with no treatment-related adverse events involving corneal endothelial cell loss or cystoid macular edema.
The study also reported no serious corneal adverse events during this period. According to the company, the overall safety findings were consistent with the established safety profile of iDose TR and previous clinical experience.
Corneal endothelial cells play a critical role in maintaining corneal clarity by regulating fluid balance within the cornea. Damage or loss of these cells can compromise corneal function and may affect vision, making endothelial safety an important consideration in ophthalmic procedures and treatments.
Cystoid macular edema is a condition involving fluid accumulation in the macula, the central portion of the retina responsible for detailed vision. It can occur following certain eye procedures, including cataract surgery, and may affect visual outcomes.
The absence of treatment-related cases of these events in the study is encouraging, particularly because the investigational setting involved administering a sustained-delivery glaucoma therapy alongside cataract surgery.
However, the reported safety findings cover the first three months of follow-up. Longer-term monitoring and additional clinical data will be important for assessing the durability of the safety profile and identifying any less common or delayed adverse events.
The reported findings nevertheless add to Glaukos’s clinical evidence base for iDose TR and support continued evaluation of the therapy in patients with glaucoma or ocular hypertension.
Leadership Highlights the Potential for Broader Treatment Applications
Thomas Burns, Chairman and Chief Executive Officer of Glaukos Corporation, welcomed the positive Phase 4 findings and emphasized their importance for the company’s ongoing development strategy.
“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,” Burns said.
He noted that the data further reinforce the versatility of iDose TR across different administration settings, demonstrating its ability to deliver clinically meaningful IOP reduction both as a standalone procedure and in conjunction with cataract surgery.
Burns also highlighted the potential of the therapy to contribute to a broader shift toward earlier, interventional approaches to glaucoma care.
His comments reflect Glaukos’s strategy of developing treatments designed to address limitations associated with conventional glaucoma management, particularly the challenges patients face when using topical medications over extended periods.
Glaucoma is generally a chronic condition requiring continued management to reduce the risk of progressive optic nerve damage. Many patients rely on daily eye drops to lower intraocular pressure, but the effectiveness of topical therapy can depend on consistent administration and long-term adherence.
By providing sustained drug delivery through a procedural approach, iDose TR is designed to offer an alternative to repeated daily medication use. The Phase 4 findings suggest that the therapy may also have a role in treatment plans for patients already undergoing cataract surgery.
Understanding iDose TR and Its Sustained-Delivery Technology
iDose TR is a long-duration intracameral procedural pharmaceutical therapy developed by Glaukos. It is designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost inside the eye for up to three years.
Travoprost is a prostaglandin analogue used to lower intraocular pressure. In conventional topical formulations, patients administer eye drops according to a prescribed schedule. The effectiveness of this approach can be influenced by whether patients use their medication consistently and correctly.
iDose TR is designed to address some of these challenges by delivering the pharmaceutical agent through a sustained-release system placed inside the eye during a procedure.
The company aims to improve glaucoma treatment by reducing dependence on repeated topical medication administration and potentially limiting certain difficulties associated with long-term eye-drop use.
These difficulties can include missed doses, problems administering drops correctly, inconvenience, and chronic side effects associated with topical medications. Such challenges can make sustained disease management difficult for some patients.
A long-duration delivery approach could provide an alternative for appropriate patients by maintaining drug delivery without requiring them to administer the same medication every day. The therapy is intended to support more consistent treatment exposure while reducing the practical burden associated with routine eye-drop use.
The potential duration of delivery is an important feature of the technology. iDose TR is designed to provide therapeutic drug delivery for up to three years, although actual treatment duration and outcomes depend on the product’s clinical performance and individual patient circumstances.
The GLK-101-04 findings expand the evidence supporting the therapy by evaluating its use alongside cataract surgery. This approach could be relevant for patients who require surgical treatment for cataracts and also have open-angle glaucoma or ocular hypertension.
Implications for Glaucoma Management and Cataract Surgery
Cataracts and glaucoma are both common eye conditions, and some patients experience them simultaneously. Cataract surgery addresses clouding of the eye’s natural lens, while glaucoma treatment focuses on lowering intraocular pressure and protecting the optic nerve from further damage.
For patients managing both conditions, coordinating cataract treatment with glaucoma care can be an important consideration.
The GLK-101-04 results indicate that iDose TR may provide an additional IOP-lowering benefit when administered during cataract surgery. The observed difference between the treatment groups suggests that incorporating the therapy into the surgical setting could offer a way to address elevated eye pressure while a patient is already undergoing an ophthalmic procedure.
The potential value of this approach extends beyond the measured reduction in intraocular pressure. A procedural treatment that provides sustained drug delivery could also reduce reliance on daily eye drops for some patients, depending on their individual treatment requirements and clinical response.
However, iDose TR should not be assumed to eliminate the need for all other glaucoma treatments or follow-up care. Glaucoma management requires ongoing assessment, and treatment decisions must be tailored to the patient’s disease severity, pressure targets, response to therapy, and other clinical factors.
The three-month Phase 4 results provide evidence of additional pressure reduction and an encouraging initial safety profile, but longer-term data will be needed to fully characterize outcomes following combined administration with cataract surgery.
Continued Clinical Evaluation Supports Glaukos’s Development Strategy
The positive topline results from GLK-101-04 represent another step in Glaukos’s efforts to expand the clinical evidence supporting iDose TR.
The trial achieved its primary efficacy endpoint and demonstrated statistically significant superiority over cataract surgery alone in reducing mean diurnal IOP at Month 3. The combination group achieved a reduction of 11.1 mmHg from baseline, compared with 7.4 mmHg in the control group, producing an incremental treatment effect of 3.6 mmHg.
The favorable three-month safety findings, including the absence of treatment-related corneal endothelial cell loss, cystoid macular edema, and serious corneal adverse events, further support continued evaluation of the therapy in this setting.
For Glaukos, the findings reinforce the potential of sustained-delivery pharmaceutical technology to address some of the challenges associated with chronic glaucoma treatment. They also support the company’s broader goal of advancing interventional treatment approaches that can complement existing management strategies.
As the company continues to evaluate iDose TR across different administration settings, further clinical evidence will help clarify its long-term benefits, safety, and potential role in routine ophthalmic practice.
Overall, the GLK-101-04 study provides encouraging evidence that iDose TR administered alongside cataract surgery can achieve greater intraocular pressure reduction than cataract surgery alone in patients with open-angle glaucoma or ocular hypertension. The results strengthen the clinical foundation for the therapy and highlight its potential to expand treatment options for patients who need both cataract surgery and ongoing pressure management.
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.