Celanese Announces Commercial Launch of Glaukos'; iDose® TR (Travoprost Intracameral Implant) Using Celanese's VitalDose® Ethylene Vinyl Acetate (EVA)
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Insights
The approval of iDose® TR by the FDA represents a significant advancement in the field of ophthalmology, particularly in the treatment of glaucoma. The use of Celanese's VitalDose® EVA in this new drug delivery system addresses a critical issue in patient care: non-compliance with medication regimens. Traditionally, glaucoma treatments require frequent eye drops, which many patients find difficult to administer consistently due to complex schedules, side effects, or physical discomfort. By offering a sustained release of medication, iDose® TR can potentially improve adherence and outcomes.
From a research perspective, the successful application of VitalDose® EVA to create a nanoporous membrane that can consistently release therapeutic levels of travoprost is a noteworthy innovation. It demonstrates the versatility of the EVA platform in addressing different drug delivery challenges. The clinical trial data, involving 1,150 subjects, underscores the safety and efficacy of this approach, which is crucial for gaining the confidence of both the medical community and patients.
The launch of iDose® TR could potentially disrupt the glaucoma treatment market by providing a more patient-friendly alternative to daily eye drops. This innovation may lead to increased demand for Glaukos's product, as it caters to a clear unmet need in the market. The fact that iDose® TR is a first-of-its-kind therapy could give Glaukos a competitive advantage, at least temporarily and could influence market dynamics in favor of sustained-release treatments.
Furthermore, the partnership with Celanese and the utilization of their VitalDose® EVA technology could pave the way for future collaborations and applications in other therapeutic areas. This could have positive implications for Celanese's business growth and market position as a provider of drug delivery solutions. It's important for stakeholders to monitor adoption rates and patient feedback, as these will be key indicators of the product's performance in the real world and its impact on the companies' financials.
The FDA approval of iDose® TR using Celanese's VitalDose® EVA technology is likely to have financial implications for both Celanese and Glaukos. For Glaukos, the approval could translate into revenue growth as the product gains market share in the glaucoma treatment sector. For Celanese, the success of iDose® TR could lead to increased demand for their VitalDose® EVA platform, potentially opening up new revenue streams from licensing or supply agreements.
Investors should consider the long-term potential of this technology, as sustained drug delivery systems are gaining traction across various medical fields. The scalability of the VitalDose® EVA platform to accommodate different drugs and conditions could result in a diverse portfolio of products, each contributing to the financial health of the company. However, it's also important to consider the costs associated with the production, marketing and potential competition that may arise as other companies seek to capitalize on this drug delivery trend.
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
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
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
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Investor Relations
Brandon Ayache
+1 972 443 8509
brandon.ayache@celanese.com
Media Relations – Global
Brian Bianco
+1 972 443 4400
media@celanese.com
Source: Celanese Corporation
FAQ
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