Parkhurst NuVision, a leading ophthalmic clinic and Glaukos have reached a significant milestone with the U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for iDose® TR (travoprost intracameral implant) 75 mcg. This pioneering prostaglandin analog represents a groundbreaking advancement in the treatment of glaucoma.
SAN ANTONIO, Dec. 19, 2023 /PRNewswire-PRWeb/ -- Parkhurst NuVision, a leading ophthalmic clinic and Glaukos have reached a significant milestone with the U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for iDose® TR (travoprost intracameral implant) 75 mcg. This pioneering prostaglandin analog represents a groundbreaking advancement in the treatment of glaucoma.
"This is a huge development and medical innovation for patients with glaucoma. The iDose slowly releases the medication under the surface of your eye so you never have to remember to put eyedrops in." said Dr. Gregory Parkhurst, a lead investigator in the clinical research trial at Parkhurst NuVision.
Parkhurst NuVision conducted clinical trials prior to the approval and the FDA looked at how well iDose TR worked in these big studies (Phase 3 trials). They found that it worked just as well as other medicine for the first 3 months and that after a year, 81% of people using iDose TR didn't need other eye medicine anymore! iDose TR is a revolutionary, pharmaceutical therapy designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost inside the eye. This transformative solution offers patients with ocular hypertension (OHT) or open-angle glaucoma (OAG), a new convenient approach that addresses common challenges associated with traditional topical glaucoma medications in the form of eyedrops.
Thomas Burns, Glaukos Chairman and Chief Executive Officer, commented on the FDA approval, stating, "The FDA approval of iDose TR represents a significant milestone for Glaukos following an extensive pioneering journey since the inception of the original idea nearly 15 years ago. Today's approval ushers in a new era of interventional glaucoma therapy by enabling a more proactive and reliable approach for patients in need."
The FDA approval is based on the success of two pivotal Phase 3 trials (GC-010 and GC-012), where iDose TR demonstrated non-inferiority to timolol ophthalmic solution in intraocular pressure (IOP) reduction during the first 3 months. At 12 months, 81% of iDose TR subjects were completely free of IOP-lowering topical medications, highlighting the long-lasting impact of this novel therapy.
Glaukos plans to launch iDose TR commercially in the latter part of the first quarter of 2024 and will make available the new technology to Parkhurst NuVision patients.
About Glaucoma
Glaucoma affects over 80 million people worldwide. Glaucoma can have a serious impact on your quality of life. Most of the time, a glaucoma patient is unaware of any vision loss. And elderly individuals, who are at the greatest risk for developing glaucoma, often attribute their loss of vision to just growing old. Vision loss from glaucoma is silent, it is slow, it is progressive, it is irreversible, but it is treatable and preventable.
About Parkhurst NuVision
Parkhurst NuVision is widely known as a premier vision correction surgery center and clinical research facility. The group practice was founded by award-winning ophthalmologist, Dr. Gregory Parkhurst. Parkhurst NuVision proudly serves the community of San Antonio, Texas, as well as the many patients who travel from across the nation for our expertise in eye surgery. As a leader in personalized vision procedures, we are committed to offering the full range of vision correction solutions, including EVO ICL, LASIK, SMILE LASIK, PRK, Lens Replacement (RLE), and Laser Cataract Surgery. Whatever your eye prescription or stage in life, the team at Parkhurst NuVision LASIK Eye Surgery San Antonio is here to help you see.
About Glaukos
Glaukos (www.glaukos.com) 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 (MIGS) 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.
Media Contact
Angie Kruse, Parkhurst NuVision, 1 3365084447, [email protected], https://sanantonio-lasik.com/
SOURCE Parkhurst NuVision
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