iDose TR demonstrates positive safety results in surgical exchange trial
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Glaukos reported positive results in a clinical trial investigating the safety of the surgical exchange procedure for the iDose TR in subjects who had previously received the implant in a phase 2b clinical trial.
The second administration of iDose TR (travoprost intraocular implant) for IOP reduction in subjects with glaucoma and the removal of the original implant in the prospective, multicenter exchange trial were well tolerated, with the second iDose TR demonstrating a favorable safety profile over 12 months, according to a company press release. The average time from administration of the first implant in the original phase 2b trial to the time of the exchange procedure was 4.2 years, with exchange trial subjects then evaluated for an additional year.
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Thirty-two subjects completed the exchange trial, and none exhibited more than 30% endothelial cell loss over the extended evaluation period of more than 5 years on average.
Glaukos plans to include the data in an upcoming new drug application submission targeted for the first quarter.
“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 NDA submission to further support the safety and tolerability of redosing iDose TR patients over time,” Thomas Burns, chairman and CEO of Glaukos, said in the release.
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