Glaukos Corporation has announced that the FDA has accepted its new drug application (NDA) for the iDose TR (travoprost intraocular implant), designed to address ubiquitous patient non-compliance and chronic side effects associated with topical glaucoma medications.
This acceptance follows the company’s NDA submission to the FDA in February 2023.
Tell me more about the iDose TR
The iDose TR is a biocompatible titanium implant administered during micro-invasive procedures that contains a proprietary formulation of travoprost—a prostaglandin analog used to lower intraocular pressure (IOP)—which is released inside the anterior chamber.
By eluting the drug already inside the eye, the device bypasses the corneal permeability barrier, enabling the release of micro-amounts of travoprost over time.
How long are these effects supposed to last?
The implant is designed to continuously release therapeutic medication levels for at least 1 year.
Once all the travoprost is released, the implant is removed and could be replaced with another implant.
Give me some clinical data on it.
Two phase 3 trials both achieved their primary efficacy endpoints (through 3 months) and reported a favorable tolerability and safety profile for the iDose TR through 12 months.
Additional positive data was also reported from an exchange trial assessing the safety and feasibility of replacing an iDose TR implant in patients who had received the original implant in a previous phase 2b trial.
OK, now talk about this NDA approval.
The FDA gave Glaukos a “Day 74” notification that acknowledged the previous NDA submission and confirmed it is permissible for review.
What’s next?
The FDA has designated December 22, 2023, as the Prescription Drug User Fee Act (PDUFA) date.
Significance?
The implant’s long-term durability and removability capabilities offers the potential for a dropless alternative to daily eye drop treatment for patients with open-angle glaucoma or ocular hypertension.