Glaukos has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its micro-invasive intraocular implant, iDose TR.
The company designed iDose TR to continuously deliver therapeutic levels of a proprietary formulation of travoprost from within the eye for longer periods.
The implant helps address ubiquitous patient non-compliance and chronic side effects related to topical glaucoma medications.
Glaukos chairman and CEO Thomas Burns said: “The submission of the iDose TR NDA represents a significant milestone for our company, resulting from more than a decade of our teams’ unrelenting research, development and clinical efforts to bring this potential game-changing therapy one step closer to patients who may need a new glaucoma treatment alternative.
“We look forward to working closely with the FDA in their pending review process and continue to believe iDose TR can be a transformative novel technology able to fundamentally improve the treatment paradigm for patients with glaucoma.”
The NDA submission includes results from two Phase II pivotal clinical trials that evaluated iDose TR.
Both trials achieved the pre-specified primary efficacy endpoints within three months and also demonstrated favourable safety and tolerability profiles over a 12 months period.
The submission also includes data from the iDose TR exchange trial.
The exchange trial included the removal of the original iDose TR implant as well as a second administration.
The second administration demonstrated a favourable safety profile over an evaluation period of 12 months.
The implant features a new travoprost formulation and is administered using a micro-invasive procedure.
iDose TR can be removed and replaced to provide a long-term dropless alternative to daily treatment with eye drops.