Glaukos Archives - Medical Design Sourcing

FDA approves Glaukos iDose TR glaucoma-treating drug delivery implant

The iDose ophthalmic device. [Image from Glaukos]Glaukos (NYSE:GKOS) announced today that the FDA approved a New Drug Application (NDA) for its iDose TR implant.

The approval allows for one administration per eye of iDose TR (travoprost intracameral implant) 75 mcg. The indication for the prostaglandin analog covers the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG).

iDose TR is a first-of-its-kind, long-duration, intracameral procedural pharmaceutical therapy. It continuously delivers 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods. Glaukos designed iDose TR to improve the standard of care by addressing patient non-compliance issues. The implant also addresses the chronic side effects associated with topical glaucoma medications.

Glaukos Chair and CEO Thomas Burns called the approval “a significant milestone” in a news release…

Medtech Big 100: These companies just missed the list

Each year, it takes more and more revenue to make our Medtech Big 100 ranking of the world’s largest medical device companies.

This year’s No. 100 — Artivion (formerly CryoLife) — secured the final spot in our ranking with revenue of $313.8 million.

Last year, $236.2 million was enough to get Cardiovascular Systems (now part of Abbott) onto the Medtech Big 100 company ranking at No. 100.

Companies on the bubble in recent years have made their way onto the Medtech Big 100. For example, Inspire Medical Systems missed the list by a single spot last year, but made No. 94 in our new ranking.

With that in mind, here are the companies that would have ranked Nos. 101 to 105 on this year’s list. Watch out for them in future versions of the Medtech Big 100.

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Glaukos beats Wall Street sales expectations in Q2

Glaukos (NYSE:GKOS) shares posted second-quarter financial results that came in well ahead of the consensus revenue forecast.

Shares of GKOS remained relatively unmoved at $74.72 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day down 1.1%.

The Aliso Viejo-based ophthalmic medical technology company posted losses of $32.8 million. That amounts to 68¢ per share on sales of $80.4 million for the three months ended June 30, 2023.

Glaukos posted a nearly $13 million bottom-line gain on sales growth of 10.6%.

Adjusted to exclude one-time items, losses per share came in at 55¢, equalling Wall Street forecasts. Sales beat expectations of $74.7 million.

“Our record second quarter results highlighted by double-digit topline growth reflect the successful execution of our commercial strategies thus far in 2023,” said Thomas Burns, G…

Glaukos agrees to market Radius XR’s wearable diagnostics in the U.S.

[Image from the RadiusXR website]Glaukos (NYSE:GKOS) announced today that it entered into a collaboration and marketing agreement with Radius XR.

Aliso Viejo, California-based Glaukos becomes the exclusive sales agent for the Radius XR wearable patient engagement and diagnostic system. The agreement gives the company the rights to market, promote and solicit orders for the platform in the U.S. Under the agreement, Radius XR continues to lead development and commercialization efforts for the platform.

The platform is a novel portable vision diagnostic and patient engagement system. Radius XR designed it to enable more efficient detection of eye disease and better management and treatment of sight-threatening conditions.

It combines medical-grade diagnostics, business management tools and patient education resources within a wearable spatial computing device. Glaukos says the hardware and software system offers tools to diagnose patients accurately, enhance e…

Glaukos stock rises on 9% Q1 revenue growth

Glaukos (NYSE:GKOS) shares ticked up this morning on first-quarter results that came in mixed compared to the consensus forecast.

Shares of GKOS rose 9% at $50.66 apiece as the market opened today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — dipped 0.03%.

The (LOCATION)-based company posted losses of $34.6 million for the quarter. That equals 72¢ per share on sales of $73.9 million for the three months ended March 31, 2023.

Glaukos’ bottom line slid deep into the red from profits of $5.4 million this time a year ago. However, sales grew by 9.2% year over year.

Adjusted to exclude one-time items, losses per share totaled 59¢, falling just 1¢ shy of Wall Street’s predictions. Sales still topped expectations, as analysts projected $67.7 million in revenue.

“I’m pleased with our strong start to the year highlighted by a return to solid topline growth in the fir…

Medtech jobs: The world’s largest medical device companies are hiring

Medical device companies are trying to fill thousand of medtech jobs. [Photo by ijeab – stock.adobe.com]

The world’s largest medical device companies are still hiring for medtech jobs despite layoffs in tech and other industries.

Medtech developers — and medtech jobs — are resilient, with the industry’s COVID-19 pandemic performance only bolstering its recession-proof reputation.

That’s not to say there haven’t been job cuts in medtech, led by thousands of layoffs at Philips as it struggles with a massive recall of deadly respiratory devices. But most medical device manufacturers are still hiring, and in some cases they can’t attract enough candidates to fill every vacancy in a tight labor market.

Stryker, for example, grew to approximately 51,000 employees as of the end of 2022, increasing its headcount by nearly 11 percent last year. Boston Scientific reported nearl…

Glaukos submits FDA New Drug Application for iDose TR drug-eluting implant

The iDose ophthalmic device. [Image from Glaukos]Glaukos (NYSE:GKOS) announced today that it submitted a New Drug Application (NDA) to the FDA for its iDose TR implant.

Aliso Viejo, California-based Glaukos designed iDose TR as a micro-invasive intraocular implant. It continuously delivers therapeutic levels of a proprietary formulation of travoprost from within the eye over extended periods of time. Once all travoprost is released, iDose TR is removed and replaced with an implant. This potentially offers an alternative to daily eye drop treatment.

Get the full story at our sister site, Drug Delivery Business News.

Glaukos beats The Street in Q4

Glaukos (NYSE:GKOS) shares took a hit today despite fourth-quarter results that topped the consensus forecast.

Shares of GKOS dipped 7% at $46.90 apiece in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 8.1%.

The Aliso Viejo, California-based ophthalmic implant maker posted losses of $31.5 million. That amounts to losses of 66¢ per share on sales of $71.2 million for the three months ended Dec. 31, 2022.

Glaukos’ bottom line slid nearly $10 million further into the red on a sales decline of 2.7%.

Adjusted to exclude one-time items, losses per share came in at 53¢. That landed 3¢ ahead of projections on Wall Street. Glaukos topped analysts’ sales estimates by 5.36%, too.

“Our fourth-quarter performance caps off a successful year of execution and key milestone achievement despite reimbursement headwinds and a challenging macroeconomic …

Glaukos beats The Street in Q3

Glaukos (NYSE:GKOS) shares hardly shifted on third-quarter results that came in ahead of the consensus forecast.

The Aliso Viejo, California-based ophthalmic implant maker posted losses of $27.6 million in the quarter. That amounts to 58¢ per share on sales of $71.3 million for the three months ended Sept. 30, 2022.

Get the full story at our sister site, Drug Delivery Business News.

5 top ophthalmic device innovations you need to know

Innovation finds its way into all areas of medtech, and ophthalmic treatments represent another burgeoning space. [Image from Pixabay]It may not be a new wave, but medtech companies continue to improve upon technologies for the human eye.

Implants, lenses and more comprise the space’s latest innovations, with a number of companies finding new ways to fix old problems.

Here are five innovations in ophthalmic technology that have caught the eye of editors here at MassDevice:

Johnson & Johnson Vision’s drug-eluting contact lens

Johnson & Johnson Vision (NYSE:JNJ) Director of Clinica Science Dr. Brian Pall told MassDevice earlier this year that researchers considered the notion of delivering medication through contact lenses as far back as the 1960s.

[Image from Johnson & Johnson Vision]It took until 2022 for that vision to come to fruition. In March, Johnson & Johnson announced that the FDA approved its Acuvue Theravision with K…

Medtech sales reach a record high as R&D spend and employee counts climb

The Medtech Big 100: The world’s largest medical device companies

The medtech industry is bouncing back from the economic fallout caused by the COVID-19 pandemic, according to an analysis of our Medtech Big 100 data.

The medical device industry has seemingly recovered from the economic headwinds caused by the COVID-19 pandemic, according to a Medical Design & Outsourcing analysis of financial data from the Medtech Big 100, 100 of the largest medical device companies’ most recent annual results.

More than half of the companies listed in this year’s Big 100 ranking reported positive growth over their prior-year sales. Total revenue, research spending and employment figures were up significantly as the industry adjusts to a world with COVID-19 challenges.

For this analysis, we compared the performance of the Medtech Big 100 companies in 2021 and early 2022 with their results in 2020. Due to t…

Phase 3 trial data support Glaukos iDose eye drop alternative

Glaukos (NYSE:GKOS) today announced positive outcomes from two Phase 3 pivotal trials for its iDose TR system.

iDose TR contains a novel formulation of travoprost, a prostaglandin analog used to reduce intraocular pressure (IOP). Glaukos designed it to continuously release therapeutic levels of medication for at least one year. Once all travoprost is released, iDose TR is removed and replaced with an implant, potentially offering an alternative to daily eye drop treatment.

Get the full story at our sister site, Drug Delivery Business News.