iDose TR has been designed to deliver therapeutic levels of a proprietary formulation of travoprost from within the eye. Credit: Mihai Moisa / Unsplash.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.