Trial results for the Hydrus Microstent, investigating treatment for refractory open-angle glaucoma, were posted on ClinicalTrials.gov on 2026-01-14. The study reported a mean reduction in diurnal intraocular pressure (MDIOP) of -3.77 mmHg at 12 months.
Background
Glaucoma is a group of eye conditions that damage the optic nerve, often due to abnormally high pressure in the eye. Open-angle glaucoma is the most common form. When conventional treatments are insufficient, the condition is considered refractory, necessitating alternative interventions to manage intraocular pressure and prevent further vision loss. This trial aimed to assess the safety and effectiveness of the Hydrus Microstent in this patient population.
Trial design
This study was completed with an enrollment of 217 subjects. Phase information was not specified. The trial investigated patients with Open-angle Glaucoma, specifically those with refractory disease. The study's purpose was to assess the safety and effectiveness of the Hydrus Microstent.
Key results
Key measurements from the trial include:
- At Month 12, the percentage of subjects with greater than or equal to a 20 percent decrease from baseline in mean diurnal intraocular pressure (MDIOP) while maintaining the same or fewer number of medications was 43.0 percentage of subjects in the Hydrus Microstent group.
- The mean change from baseline in MDIOP at Month 12 was -3.77 mmHG (Standard Deviation 5.0) in the Hydrus Microstent group.
What this means
The results indicate that the Hydrus Microstent can lead to a clinically meaningful reduction in intraocular pressure for patients with refractory open-angle glaucoma. A mean reduction of -3.77 mmHG in MDIOP, coupled with 43.0% of subjects achieving a significant pressure decrease while maintaining or reducing medication, suggests a potential benefit for managing this challenging condition. These findings support the role of the Hydrus Microstent as an option for patients struggling to control their intraocular pressure with conventional therapies.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03267134, titled "Hydrus Microstent for Refractory Open-Angle Glaucoma", were posted on 2026-01-14 on clinicaltrials.gov.