DALLAS–(BUSINESS WIRE)–$CE–Celanese Corporation (NYSE: CE), a global specialty materials and chemical company, announced the launch of iDose® TR by Glaukos Corporation using Celanese’s VitalDose® EVA to provide sustained drug release for the treatment of glaucoma.
The majority of glaucoma and ocular hypertension patients are non-compliant with topical medication use due to complex dosing regiments, side effects, and eye-drop intolerance. Sustained delivery of therapeutics provides an important approach in addressing non-compliance and improving treatment outcomes. With iDose® TR and the VitalDose® EVA, there is now the opportunity to provide continuous dosing which can improve patient compliance and address adherence issues.
iDose® TR was approved by the Food and Drug Administration (FDA) in December 2023 and is a first-of-its-kind, long-duration, intracameral procedural pharmaceutical therapy designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time. iDose® TR was approved on the basis of two pivotal trials (1,150 subjects randomized across both trials), which demonstrated safety and efficacy.
Glaukos used the VitalDose® EVA to create a nanoporous membrane for travoprost delivery in iDose® TR. The VitalDose® EVA is a platform that can be formulated into a wide range of form factors to suit drug delivery needs for various conditions.
“A clear unmet need exists in ophthalmology for therapies that address non-compliance and reduce the treatment burden for patients,” says Cyonna Holmes, global business strategy leader for Ophthalmology and RNA at Celanese. “Our team is excited to support Glaukos as they transform the landscape of glaucoma treatment for millions of patients.”
The VitalDose® EVA Drug Delivery Platform provides reliable, controlled-release performance and has a long history of use in approved parenteral drug products in the United States and Europe. For more information on Celanese VitalDose® technology, visit www.vitaldose.com.
About Celanese
Celanese is a global leader in chemistry, producing specialty material solutions used across most major industries and consumer applications. Our businesses use our chemistry, technology and commercial expertise to create value for our customers, employees and shareholders. We are committed to sustainability by responsibly managing the materials we create for their entire lifecycle and are growing our portfolio of sustainable products to meet increasing customer and societal demand. We strive to make a positive impact in our communities and foster inclusivity across our teams. Celanese is a Fortune 500 company that employs approximately 12,400 employees worldwide with 2023 net sales of $10.9 billion.
iDose TR Indication and Important Safety Information
INDICATIONS AND USAGE
iDose TR (travoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
Dosage and Administration
For ophthalmic intracameral administration. The intracameral administration should be carried out under standard aseptic conditions.
Contraindications
iDose TR is contraindicated in patients with active or suspected ocular or periocular infections, patients with corneal endothelial cell dystrophy (e.g., Fuch’s Dystrophy, corneal guttatae), patients with prior corneal transplantation, or endothelial cell transplants (e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [DSAEK]), patients with hypersensitivity to travoprost or to any other components of the product.
Warnings and Precautions
iDose TR should be used with caution in patients with narrow angles or other angle abnormalities. Monitor patients routinely to confirm the location of the iDose TR at the site of administration. Increased pigmentation of the iris can occur. Iris pigmentation is likely to be permanent.
Adverse Reactions
In controlled studies, the most common ocular adverse reactions reported in 2% to 6% of patients were increases in intraocular pressure, iritis, dry eye, visual field defects, eye pain, ocular hyperaemia, and reduced visual acuity.
Contacts
Investor Relations
Brandon Ayache
+1 972 443 8509
brandon.ayache@celanese.com
Media Relations – Global
Brian Bianco
+1 972 443 4400
media@celanese.com