Positive results for iDose TR Exchange trial, highlighting favorable safety and tolerability
Glaukos Corporation announced positive results for a prospective, multi-center clinical trial designed to evaluate the safety of the surgical exchange procedure for iDose TR(travoprost intraocular implant) in subjects who had previously been administered an iDose TR in the Phase IIb clinical trial (referred to as the “exchange trial”)
Results from the exchange trial demonstrated a second administration of iDose TR and removal of the original iDose TR implant was safe and well-tolerated, with the second iDose TR demonstrating a favorable safety profile over a 12-month evaluation period. Additionally, no subject in the exchange trial exhibited a greater than 30% endothelial cell loss over the extended evaluation period of more than five years on average. Glaukos plans to include the exchange trial’s positive data set in its upcoming FDA New Drug Application (NDA) submission targeted for the first quarter of 2023.
“We are pleased to clinically confirm the iDoseTR 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,” said Thomas Burns, Glaukos chairman and chief executive officer. “We continue to believe iDose TR can be a transformative novel technology able to fundamentally improve the treatment paradigm for patients with glaucoma.”
The exchange trial, based upon an agreement with the FDA, was designed to evaluate the feasibility and safety of a surgical exchange procedure of iDose TR in subjects who were previously implanted with iDose TR as part of the iDose TR Phase IIb clinical trial. A total of 33 subjects were enrolled and 32 subjects (97.0%) completed the trial. The average time from administration of the first implant (first implantation cycle) in the Phase IIb trial to the time of the exchange procedure of the second implant in the exchange trial (second implantation cycle) was 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.
During the exchange procedure using the pre-loaded injector, the surgeon inserted and anchored the new implant into the sclera at least one clock hour away from the previous implant from the first implantation cycle, and using the now-empty inserter, grasped and removed the previous implant. Administered during a micro-invasive procedure, the iDose TR contains a novel formulation of travoprost, a prostaglandin analog used to lower intraocular pressure. Once all the travoprost is released, the iDose TR is designed to be removed and replaced with a new iDose TR, thus potentially offering a dropless alternative to daily eye drop treatment.
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