FDA accepts iDose TR new drug application
Click Here to Manage Email Alerts
Key takeaways:
- The FDA accepted the new drug application for iDose TR.
- The PDUFA date is Dec. 22.
The FDA accepted a new drug application for iDose TR, an intraocular implant designed to continuously deliver travoprost to lower IOP in open-angle glaucoma or ocular hypertension, according to a Glaukos press release.
The prescription drug user fee act goal date is Dec. 22.
The NDA was submitted to the FDA in February and included data from two phase 3 pivotal trials that “achieved the prespecified primary efficacy endpoints through 3 months and demonstrated a favorable tolerability and safety profile through 12 months,” according to the release.
“The acceptance of the iDose TR NDA represents another important step in bringing this potential game-changing therapy one step closer to patients who may need a new treatment alternative,” Thomas Burns, Glaukos chairman and CEO, said in the release.
The submission also included data from an exchange trial in which the original iDose TR was removed with a second administration of iDose TR. The second administration demonstrated a favorable safety profile during the 12-month evaluation.
Read more about
Click Here to Manage Email Alerts