Glaukos' (GKOS) iDose TR Gets FDA Nod for Glaucoma Treatment
Glaukos Corporation GKOS announced that the FDA has approved its iDose TR (travoprost intracameral implant). The approval is for slow-release 75mcg iDose TR for the reduction of intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma.
The approval is based on data from a phase III program consisting of two pivotal studies that evaluated the safety and efficacy of a single administration of one of two iDose TR models with different travoprost release ratesin reducing IOP in subjects with open-angle glaucoma or ocular hypertension.
This revolutionary, micro-invasive injectable treatment marks a new era in interventional glaucoma therapy.
Price Performance
Share of Glaukos have risen more than 30% following the FDA approval. The company’s shares have risen 81% year to date compared with the industry’s 1.7% growth. The S&P 500 Index has increased 23.4% in the same time frame.
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Strategic Advantages: A New Era in Interventional Glaucoma
iDose TR is designed for a single administration per eye, sets itself apart as a long-duration, intracameral procedural pharmaceutical therapy. By delivering continuous therapeutic levels of travoprost, it addresses the challenges of patient non-compliance and chronic side effects associated with conventional topical glaucoma medications. This approval positions Glaukos as a frontrunner in redefining the standard of care for glaucoma patients.
Data from the pivotal studies demonstrated that a remarkable 81% of iDose TR subjects were free of IOP-lowering topical medications at 12 months. The clinical studies showcased excellent tolerability and subject retention, positioning iDose TR as a potential solution to the challenges posed by traditional glaucoma treatments.
Commercial Outlook
Glaukos plans to initiate commercial activities for iDose TR in the latter part of the first quarter of 2024. With a wholesale acquisition cost of $13,950 per dose, the company aims to bring this innovative therapy to the forefront of interventional glaucoma treatment.
GKOS’ reaffirmation of 2023 net sales projection and introduction of preliminary 2024 net sales guidance, ranging between $350 million and $360 million, underscore the confidence in iDose TR's potential to contribute significantly to Glaukos' growth in the coming years.
Glaukos Corporation Price
Glaukos Corporation price | Glaukos Corporation Quote
Zacks Rank & Stocks to Consider
Glaukos currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Integer Holdings ITGR, HealthEquity, Inc. HQY and Biodesix BDSX.
Integer Holdings, carrying a Zacks Rank #1 (Strong Buy) at present, has an estimated long-term growth rate of 33.6%. You can see the complete list of today’s Zacks #1 Rank stocks here.
ITGR’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 11.98%. The company’s shares have risen 42.5% year to date compared with the industry’s 1.7% growth.
HealthEquity, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 26.8%. HQY’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 16.5%.
The company’s shares have rallied 15% year to date against the industry’s 9.9% decline.
Biodesix, carrying a Zacks Rank #2 at present, has an estimated growth rate of 32.3% for 2024. BDSX’s earnings surpassed estimates in three of the trailing four quarters and missed once, delivering an average surprise of 9.76%.
The stock has fallen 30.9% year to date compared with the industry’s 9.9% decline.
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