Glaukos (NYSE:GKOS) announced today that it submitted a New Drug Application (NDA) to the FDA for its iDose TR implant.
Aliso Viejo, California-based Glaukos designed iDose TR as a micro-invasive intraocular implant. It continuously delivers therapeutic levels of a proprietary formulation of travoprost from within the eye over extended periods of time. Once all travoprost is released, iDose TR is removed and replaced with an implant. This potentially offers an alternative to daily eye drop treatment.
The system addresses ubiquitous patient non-compliance. It also treats chronic side effects associated with topical glaucoma medications.
Glaukos’ FDA submission follows data from two Phase 3 pivotal trials that both achieved pre-specified primary efficacy endpoints at three months. Data demonstrated a favorable tolerability and safety profile through 12 months, too.
The company’s iDose TR exchange trial also included a second administration of the treatment and removal of the original implant. In this study, the second administration demonstrated a favorable safety profile over 12 months.
When Glaukos reported this trial data, the company said it expected FDA review and a decision by the end of 2023.
“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,” said Thomas Burns, Glaukos chair and CEO. “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.”
