Glaukos Corporation has released positive results from a prospective, multi-center clinical trial assessing the safety of the iDose TR (travoprost intraocular implant) surgical exchange procedure in patients who were administered an iDose TR in a previous phase 2b clinical.
Tell me about the iDose TR.
The iDose TR is a biocompatible titanium implant administered during micro-invasive procedures contains a novel formulation of travoprost—a prostaglandin analog used to lower IOP—which is released inside the anterior chamber. By eluting the drug already inside the eye, the device can then bypass the corneal permeability barrier, enabling the release of micro-amounts of travoprost over time.
Watch the procedure here.
How long does the implant last?
Glaukos designed the iDose TR to continuously release therapeutic medication levels for at least 1 year. Once all the travoprost is released, the implant is removed and replaced with another implant.
What was the purpose of this trial?
The exchange trial was based on an FDA agreement and was created to assess the safety and feasibility of exchanging iDose TR implants in patients who had received an iDose TR in a previous trial.
So what did it include?
A total of 33 patients were enrolled (with 32 completing the trial). Researchers removed the original iDose implant in participants from the initial phase 2b trial and inserted/anchored the new implant—using a preloaded injector— into the sclera at least one clock hour away from the first implant. Of note, the surgeons repurposed the empty inserter to grasp and remove the first implant.
The average time between first and second implants of the iDose TR was 4.2 years. Patients were followed for an additional year after the second implantation for an overall evaluation period of 5.2 years. (via)
What did they find?
The trial indicated the exchange procedure was well-tolerated; the second iDose TR displayed a favorable safety profile over the 12-month evaluation period.
Further, no subjects demonstrated greater than 30% corneal endothelial cell loss over the extended 5.2-year evaluation period.
Significance?
The initial implant and second implant of the iDose TR—as well as its travoprost formulation—offers the potential of a dropless treatment alternative to daily eye drops.
Glaukos’s chairman and CEO Thomas Burns stated that the technology has the potential to fundamentally change the treatment paradigm for patients with glaucoma.
What’s next?
Glaukos plans on using these results in its new drug application (NDA) submission to the FDA, which is expected in Q1 of 2023.