Glaukos has submitted a New Drug Application (NDA) to the US drug regulator – the FDA – for its iDose TR travoprost intraocular implant for glaucoma.
The ophthalmic medical technology and pharmaceutical company said its iDose TR is a micro-invasive intraocular implant designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost within the eye for extended periods.
The therapy is intended to address patient non-compliance and chronic side effects associated with topical glaucoma medications.
“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,” Glaukos chairman and CEO Mr Thomas Burns said.
“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 data from two Phase 3 pivotal trials of iDose TR, which both achieved the pre-specified primary efficacy endpoints through three months and demonstrated a favourable tolerability and safety profile through 12 months.
In addition, the submission includes data from the iDose TR exchange trial, which included a second administration of iDose TR and removal of the original iDose TR, with the second iDose TR administration demonstrating a favourable safety profile over a 12-month evaluation period.
Administered during a micro-invasive procedure, the iDose TR contains a novel formulation of travoprost, a prostaglandin analog used to lower intraocular pressure. The device is can be removed and replaced with a new iDose TR, potentially offering a long-term dropless alternative to daily eye drop treatment.
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