Glaukos Corporation (NYSE: GKOS), a leader in ophthalmic medical technology and pharmaceuticals, has received the “Day 74” notification from the U.S. Food and Drug Administration (FDA) confirming that the New Drug Application (NDA) for iDose® TR (travoprost intraocular implant) has been approved for a substantive review.
The FDA has set a target date of December 22, 2023 for the completion of the review, granting Glaukos a 10-month period to review the 505(b)(2) filing. This is in line with management’s expectations for the NDA.
The acceptance of the iDose TR NDA by the FDA marks a significant milestone in delivering a potentially revolutionary therapy to those with open-angle glaucoma or ocular hypertension. Thomas Burns, Glaukos’ chairman and chief executive officer, expressed his enthusiasm in bringing this much-needed treatment closer to those who need it, and the company looks forward to working closely with the FDA to ensure a successful review process. With iDose TR, Glaukos is poised to revolutionize the treatment paradigm for these conditions.
The NDA submission for iDose TR included data from two successful Phase 3 pivotal trials, proving the efficacy and safety of the product through 3 and 12 months, respectively. Furthermore, the iDose TR exchange trial included a second administration of the product, with an evaluation period of 12 months, which further demonstrated its favorable safety profile.
iDose TR offers a revolutionary, micro-invasive solution to open-angle glaucoma and ocular hypertension. This intraocular implant is designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost, eliminating the need for daily eye drop treatment and its associated patient non-compliance and chronic side effects.
With the ability to be removed and replaced with a new iDose TR, this dropless alternative can offer patients a long-term solution to lowering intraocular pressure.
Glaukos is revolutionizing the treatment of glaucoma, corneal disorders, and retinal diseases. Through their pioneering Micro-Invasive Glaucoma Surgery (MIGS) in 2012, they have successfully created an alternative to traditional glaucoma treatment protocols.
Glaukos is continuing to develop cutting-edge technological platforms which provide superior treatment options and improved standards of care for these vision-threatening conditions. Their innovative products and product candidates provide improved outcomes for those suffering from eye diseases.