Glaukos Corporation Glaukos Corporation announced positive topline results from its Phase 4 trial of iDose TR. The GLK-101-04 trial evaluated iDose TR with cataract surgery. The combination was compared to cataract surgery alone, the researchers said. Participants had open angle glaucoma (OAG) or ocular hypertension (OHT). Glaukos is an eye pharmaceutical and medical device company. The emphasis is on new treatments for glaucoma, corneal diseases and retinal diseases.
iDose TR Achieves Primary Efficacy Endpoint in Phase 4 Clinical Trial
The primary efficacy endpoint of the study was met. iDose TR was statistically superior to mean diurnal intraocular pressure (IOP) reduction. The combination approach was superior to cataract surgery alone. At month 3, mean diurnal IOP reduction from baseline was 11.1 mmHg in the combination group. The group that had cataract surgery alone, in contrast, saw a reduction of 7.4 mmHg. This difference represents a clinically significant incremental treatment effect of 3.6 mmHg (p<0.0001).
In all pre-specified secondary responder analyzes, the iDose TR was also statistically significantly superior. These findings support the consistency and robustness of the treatment effect observed in the study announced topline positive results from its Phase 4 trial of iDose® TR . The trial, GLK-101-04, assessed iDose TR in combination with cataract surgery. The combination was compared to cataract surgery alone, the researchers said. Participants had open angle glaucoma (OAG) or ocular hypertension (OHT). Glaukos is an eye pharmaceutical and medical device company. The emphasis is on new treatments for glaucoma, corneal diseases and retinal diseases.
iDose TR Achieves Primary Efficacy Endpoint in Phase 4 Clinical Trial
The primary efficacy endpoint of the study was met. iDose TR was statistically superior to mean diurnal intraocular pressure (IOP) reduction. The combination approach was superior to cataract surgery alone. At month 3, mean diurnal IOP reduction from baseline was 11.1 mmHg in the combination group. The group that had cataract surgery alone, in contrast, saw a reduction of 7.4 mmHg. This difference represents a clinically significant incremental treatment effect of 3.6 mmHg (p<0.0001). In all pre-specified secondary responder analyzes, the iDose TR was also statistically significantly superior. These results support the robustness and consistency of the treatment effect found in the study.
“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.”
Trial Design and iDose TR Long-Duration Glaucoma Therapy
GLK-101-04 is a Phase 4, prospective, multicenter, randomized, double-masked, parallel-group clinical trial. It evaluates the efficacy and safety of iDose TR combined with cataract surgery. The comparison arm received cataract surgery alone. Adults with OAG or OHT took part in the study. The study randomized 149 study eyes. Of these, 74 eyes joined the iDose TR plus cataract surgery arm. Meanwhile, 75 eyes joined the cataract surgery alone. The primary endpoint measured 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. It continuously delivers 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for up to three years. Moreover, iDose TR aims to improve the standard of care. It tackles the ubiquitous patient non-compliance issues and chronic side effects associated with topical glaucoma medications.
Explore Health Tech Insiders for the latest medical innovations and reliable strategic insights driving the future of technology-driven healthcare transformation.
News Source: Businesswire.com
