Glaukos announced positive results for a prospective, multicenter clinical trial designed to assess the safety of the surgical exchange procedure for iDose TR (travoprost intraocular implant) in subjects who had previously received an iDose TR in the phase 2b clinical trial (dubbed the "exchange trial").
The exchange trial results showed that a second administration of iDose TR and removal of the initial iDose TR implant were both safe and well-tolerated, with the second iDose TR exhibiting a good safety profile during a 12-month evaluation period.
Furthermore, no individual in the exchange study experienced more than 30% endothelial cell loss throughout an average evaluation duration of more than 5 years. Glaukos intends to include the good data from the exchange trial in its future FDA new drug application (NDA) submission, which is scheduled 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,” Thomas Burns, Glaukos chairman and chief executive officer, said in a company news release. “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 2b clinical trial. A total of 33 subjects were enrolled and 32 subjects (97%) completed the trial.
The average time from administration of the first implant (first implantation cycle) in the phase 2b 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 process, the surgeon inserted and anchored the new implant into the sclera at least one clock hour away from the prior implant from the first implantation cycle, and grabbed and removed the former implant using the now-empty inserter.
The iDose TR, which is administered during a micro-invasive technique, contains a unique formulation of travoprost, a prostaglandin analog used to decrease IOP. The iDose TR is designed to be removed and replaced with a new iDose TR once all of the travoprost has been delivered, potentially enabling a dropless alternative to daily eye drop treatment.