has 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: 鈥淭he submission of the iDose TR NDA represents a significant milestone for our company, resulting from more than a decade of our teams鈥� 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.
鈥淲e 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.鈥�
The NDA submission includes results from two Phase II pivotal clinical trials that evaluated iDose TR.
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By GlobalDataBoth 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.
