Celanese Announces Commercial Launch of Glaukos' iDose® TR (Travoprost Intracameral Implant) Using Celanese's VitalDose® Ethylene Vinyl Acetate (EVA)
29 Febrero 2024 - 8:00AM
Business Wire
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240229678316/en/
Investor Relations Brandon Ayache +1 972 443 8509
brandon.ayache@celanese.com
Media Relations – Global Brian Bianco +1 972 443 4400
media@celanese.com
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