Therapy Areas: Devices
Glaukos Receives FDA Acceptance of NDA Submission for iDose TR
8 May 2023 - - US-based ophthalmic medical technology and pharmaceutical company Glaukos Corp. (NYSE: GKOS) has received the "Day 74" notification from the US Food and Drug Administration acknowledging the previously submitted New Drug Application for iDose TR (travoprost intraocular implant) is sufficiently complete to permit a substantive review, the company said.

The Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA's review of the iDose TR NDA is set for December 22, 2023. This date reflects a standard 10-month review period and is consistent with management's expectations for the 505(b) (2) filing.

The NDA submission includes data from two Phase 3 pivotal trials of iDose TR, which both successfully achieved the pre-specified primary efficacy endpoints through 3 months and demonstrated a favorable tolerability and safety profile through 12 months.

In addition, the submission also 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 favorable safety profile over a 12-month evaluation period.

iDose TR is a micro-invasive intraocular implant designed to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. 

iDose TR is designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost from within the eye for extended periods of time.

It is designed such that it can be removed and replaced with a new iDose TR, thus potentially offering a long-term dropless alternative to daily eye drop treatment. 

iDose TR is intended to address ubiquitous patient non-compliance and chronic side effects associated with topical IOP-lowering medications.

Glaukos is an ophthalmic medical technology and pharmaceutical company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases.

Glaukos first developed Micro-Invasive Glaucoma Surgery as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012, and continues to develop a portfolio of technologically distinct and leverageable platforms to support ongoing pharmaceutical and medical device innovations.

Products or product candidates for each of these platforms are designed to advance the standard of care through better treatment options across the areas of glaucoma, corneal disorders and retinal diseases.