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International

Glaukos' iStent inject meets primary and secondary endpoints in US-based trial

04/06/2018
Data from Glaukos’ two-year US trial of its iStent inject has shown the Trabecular Micro-Bypass System achieved a significant reduction in unmedicated intraocular pressure (IOP) in glaucoma patients undergoing cataract surgery.

Results from the 24-month trial of the device, which is designed to improve aqueous humor outflow into Schlemm’s canal and reduce IOP in mild-to-moderate open-angle glaucoma (OAG) patients undergoing cataract surgery, were presented at this year’s annual meeting of the American Society of Cataract and Refractive Surgery (ASCRS).

The device includes two heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to inject stents into multiple trabecular meshwork locations through a single corneal entry point.

"After 24 months, 75.3% of the iStent inject cohort achieved a 20% or greater reduction in unmedicated iop, compared to 61.9% for the cataract-only cohort"

More than 500 OAG patients were involved in the prospective, randomised, multicentre clinical trial, which included 387 subjects who were treated with the device in combination with cataract surgery, and 118 who underwent cataract surgery only.

According to Glaukos, the device met both primary and secondary effectiveness endpoints. Results from the trial indicated that after 24 months, 75.3% of the iStent inject cohort achieved a 20% or greater reduction in unmedicated IOP, compared to 61.9% for the cataract-only cohort.

The results also showed the mean unmedicated IOP reduction was 6.9 mmHg for the iStent inject cohort, compared to 5.4 mmHg for the cataract-only cohort.

Glaukos indicated the overall rate of adverse events for the iStent inject in combination with cataract surgery was similar to cataract surgery only.

Additionally, while not part of the effectiveness claims being pursued by the company, it reported that the iStent inject cohort achieved a 31% mean reduction in unmedicated (post-washout) IOP to 17.1 mmHg from an unmedicated (post-washout) mean baseline IOP of 24.8 mmHg.

Observed data also showed that 62.6% of the iStent inject cohort achieved unmedicated mean IOP at or below 18 mmHg, compared to 49.2% for the cataract-only cohort, while at 23 months, the iStent inject cohort achieved a 75% reduction in the mean number of medications, compared to 47% for the cataract-only cohort.

The iStent inject relies on the same fluidic method of action as the Glaukos’ first-generation iStent Trabecular Micro-Bypass Stent. However, it is approximately 0.23 mm x 0.36 mm, or about one-third the size of iStent.

While not approved for sale in the US, it is commercially available in a number of other jurisdictions around the world, including Australia.



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