Glaukos Announces Positive Trial Results for iDose® TR

Anterior segment specialists (and ophthalmologists, in general) can look forward to an exciting new surgical tool in the near future. Glaukos Corporation (California, USA), a major ophthalmic medical technology and pharmaceutical company, has announced that one of its flagship designs has successfully undergone multi-clinical testing. It’s called the iDose® TR (travoprost intraocular implant) and it looks like it holds considerable promise for the treatment of glaucoma.

The iDose TR is particularly interesting as it includes a novel formulation of travoprost, a prostaglandin analog used to lower intraocular pressure. Once the travoprost is fully released over time, the iDose TR is designed to be removed and replaced with a new device. This is designed to work as an alternative to daily eye drop treatment for patients, which could significantly improve both patient compliance and outcomes.

The testing period began with subjects being administered an iDose TR in a phase 2b clinical trial, which was then replaced with another iDose TR. The second device was then monitored and was found to be “safe and well-tolerated,” with “a favorable safety profile over a 12-month evaluation period.” No subjects exhibited a greater than 30% endothelial cell loss over the extended evaluation period of more than five years (on average).

All in all, 33 subjects were enrolled and 32 subjects (97.0%) completed the trial, with the average time from administration of the first implant to the exchange procedure of the second implant being 4.2 years. The exchange trial subjects were then followed for an additional year following the second implantation cycle, for an overall extended evaluation period average of 5.2 years.

“We are pleased to clinically confirm the iDose TR exchange procedure is safe and facile. We look forward to including these positive data in our upcoming new drug application (NDA) submission to further support the safety and tolerability of redosing iDose TR patients over time,” said Thomas Burns, chairman and CEO for Glaukos. “We continue to believe iDose TR can be a transformative novel technology able to fundamentally improve the treatment paradigm for patients with glaucoma.”

More information about the iDose TR and the Glaukos Corporation can be found on the company’s website. It has plans to include the exchange trial’s positive data set in its upcoming U.S. Food and Drug Administration (FDA) NDA submission, targeted for the first quarter of 2023. More updates about this process will be published in CAKE magazine in due course.

Notify of
Inline Feedbacks
View all comments