Glaukos Corporation (NYSE:GKOS), an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, announced today that results of an international glaucoma study published in Ophthalmology Glaucoma showed standalone implantation of two iStent Trabecular Micro-Bypass Stents in newly diagnosed primary open-angle glaucoma (POAG) eyes achieved a 35.3% reduction in mean intraocular pressure (IOP) to 16.5 mmHg after five years of follow-up.
The purpose of this prospective, randomized, controlled, multi-surgeon clinical trial was to evaluate the five-year safety and efficacy of two iStents vs. topical prostaglandin as an initial intervention in POAG subjects who had not had prior glaucoma treatment of any kind. A total of 101 subjects were randomized in a 1:1 ratio to receive either two iStents in a standalone procedure or once-daily topical travoprost, a commonly prescribed prostaglandin. At five years, results showed:
- Mean diurnal IOP was 16.5 mmHg (35.3% reduction; p < 0.0001) for the stent group vs. 16.3 mmHg (35.1% reduction) for the travoprost group, excluding eyes in both cohorts that underwent cataract surgery during follow-up.
- Treatment success “ defined as mean diurnal IOP of 6 mmHg to 18 mmHg without add-on medication or secondary glaucoma surgery “ was achieved in 77% of stent eyes vs. 53% of travoprost eyes (p = 0.04).
- Seventeen percent of stent eyes vs. 44% of travoprost eyes required add-on medication.
- The need for add-on medication arose at a slower rate in the stent group than in the travoprost group, especially after two years of follow-up. Study authors observed that from two to five years of follow-up, add-on medications were initiated in roughly double the number of travoprost eyes vs. stent eyes.
- The safety profile was excellent in both groups throughout follow-up.
These results illustrate the enduring efficacy and safety of using multiple trabecular bypass stents in a standalone procedure as initial intervention to manage IOP in newly diagnosed, treatment-na¯ve glaucoma patients, said Robert D. Fechtner, MD, an ophthalmic surgeon based in Syracuse, NY and lead author of the Ophthalmology Glaucoma article. Topical ocular hypotensive medications are typical first-line glaucoma therapy but these drugs can be ineffective due to high rates of patient non-adherence, ocular surface damage, cost and other factors. This study shows that not only are Glaukos iStents as effective as once-daily topical travoprost in controlling IOP, but they also succeed at maintaining IOP reductions over the long-term with fewer additional medications.
Three-year outcomes of this study were published in 2016 in Ophthalmology and Therapy. The most recent article detailing five-year outcomes may be accessed online here.
This latest publication represents the first-ever five-year, protocol-driven, randomized evaluation of standalone iStent implantation in newly diagnosed glaucoma patients, said Thomas Burns, Glaukos president and chief executive officer. Moreover, it adds meaningful outcomes data to the growing body of peer-reviewed evidence that implantation of a single or multiple iStents can reliably achieve sustained IOP reductions in an elegant, tissue-sparing procedure with a highly favorable safety profile.
Glaukos, the study sponsor, is the pioneer of Micro-Invasive Glaucoma Surgery, or MIGS. The U.S. Food & Drug Administration (FDA) approved the companys first MIGS device, the iStent, in 2012 and approved its second-generation iStent injectTrabecular Micro-Bypass System in 2018. Inserted through a small corneal incision made during cataract surgery, the iStent is designed to reduce IOP by restoring the natural physiological outflow of aqueous humor. The iStent inject relies on the same fluidic method of action but is designed to deploy two stents into separate trabecular meshwork locations through a single corneal entry point for enhanced IOP reduction and procedural ease. The iStent inject is also approved for use in conjunction with cataract surgery or as a standalone procedure in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore, South Africa and other international markets.
Glaucoma is characterized by progressive, irreversible vision loss caused by optic nerve damage. There is no cure for the disease. However, by reducing the eye pressure, the only proven effective treatment, vision may be stabilized. Based on analysis of population-based surveys, medical claims data and other statistics, the company estimates that there are approximately 5.4 million people in the U.S. with POAG, the most common form of the disease.
About iStent inject Trabecular Micro-Bypass System (U.S.)
Indication for Use: The iStent inject Trabecular Micro-Bypass System Model G2-M-IS is indicated for use in conjunction with cataract surgery for the reduction of IOP in adult patients with mild-to-moderate primary open-angle glaucoma.
Contraindications: The iStent inject is contraindicated in eyes with angle-closure glaucoma, traumatic, malignant, uveitic, or neovascular glaucoma, discernible congenital anomalies of the anterior chamber angle, retrobulbar tumor, thyroid eye disease, or Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
Warnings: Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard.
MRI Information: The iStent inject is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details.
Precautions: The surgeon should monitor the patient postoperatively for proper maintenance of IOP. The safety and effectiveness of the iStent inject have not been established as an alternative to the primary treatment of glaucoma with medications, in children, in eyes with significant prior trauma, abnormal anterior segment, chronic inflammation, prior glaucoma surgery (except SLT performed > 90 days preoperative), glaucoma associated with vascular disorders, pseudoexfoliative, pigmentary or other secondary open-angle glaucomas, pseudophakic eyes, phakic eyes without concomitant cataract surgery or with complicated cataract surgery, eyes with medicated IOP > 24 mmHg or unmedicated IOP < 21 mmHg or > 36 mmHg, or for implantation of more or less than two stents.
Adverse Events: Common postoperative adverse events reported in the randomized pivotal trial included stent obstruction (6.2%), intraocular inflammation (5.7% for iStent inject vs. 4.2% for cataract surgery only), secondary surgical intervention (5.4% vs. 5.0%) and BCVA loss ‰¥ 2 lines ‰¥ 3 months (2.6% vs. 4.2%).
Caution: Federal law restricts this device to sale by, or on the order of, a physician. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.
For more information, visit www.glaukos.com.
About iStent Trabecular Micro-Bypass Stent (U.S.)
Indication for Use: The iStent Trabecular Micro-Bypass Stent is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild-to-moderate open-angle glaucoma currently treated with ocular hypotensive medication.
Contraindications: The iStent is contraindicated in eyes with primary or secondary angle closure glaucoma, including neovascular glaucoma, as well as in patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
Warnings: Gonioscopy should be performed prior to surgery to exclude PAS, rubeosis, and other angle abnormalities or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard. The iStent is MR-Conditional meaning that the device is safe for use in a specified MR environment under specified conditions, please see label for details.
Precautions: The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. The safety and effectiveness of the iStent has not been established as an alternative to the primary treatment of glaucoma with medications, in children, in eyes with significant prior trauma, chronic inflammation, or an abnormal anterior segment, in pseudophakic patients with glaucoma, in patients with pseudoexfoliative glaucoma, pigmentary, and uveitic glaucoma, in patients with unmedicated IOP less than 22 mmHg or greater than 36 mmHg after washout of medications, or in patients with prior glaucoma surgery of any type including argon laser trabeculoplasty, for implantation of more than a single stent, after complications during cataract surgery, and when implantation has been without concomitant cataract surgery with IOL implantation for visually significant cataract.
Adverse Events: The most common post-operative adverse events reported in the randomized pivotal trial included early post-operative corneal edema (8%), BCVA loss of ‰¥ 1 line at or after the 3 month visit (7%), posterior capsular opacification (6%), stent obstruction (4%) early post-operative anterior chamber cells (3%), and early post-operative corneal abrasion (3%). Please refer to Directions for Use for additional adverse event information.
Caution: Federal law restricts this device to sale by, or on the order of, a physician. Please reference the Directions for Use labeling for a complete list of contraindications, warnings, precautions, and adverse events.
Glaukos (www.glaukos.com) is an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, one of the worlds leading causes of blindness. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent, its first MIGS device, in the United States in July 2012 and launched its next-generation iStent inject device in the United States in September 2018. Glaukos is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company believes the iStent inject, measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device ever approved by the FDA.
All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control, that may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this press release. These potential risks and uncertainties include, without limitation, the continued efficacy and safety profile of our products as might be suggested in the published research referenced above. These risks, uncertainties and factors are described in detail under the caption Risk Factors and elsewhere in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2018. Our filings with the Securities and Exchange Commission are available in the Investor Section of our website at www.glaukos.com or at www.sec.gov. In addition, information about the risks and benefits of our products is available on our website at www.glaukos.com. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.
Lewis, Director, Investor Relations, Corporate Development & Strategy
Ideal Credit Union Has Paid Its Members Over $4.6 Million as Part of Its Exclusive VIP+ Program
WOODBURY, Minn., Jan. 18, 2021 /PRNewswire-PRWeb/ — Ideal Credit Union has paid $438,200 in Patronage Dividends to 3,381 qualified members as part of its exclusive VIP+ Program, which aims to reward members for their patronage and for actively participating in the cooperative. Funds were deposited into members' savings accounts on January 2, 2021 and available that same day. Since 2013, Ideal CU has paid out over $4.6 million to VIP+ members.
The recent payout marks Ideal CU's 9th consecutive year returning a percentage of its annual profits back to its members through the VIP+ Program.
“We are especially grateful to be able to provide a VIP Plus payout this year. This is a direct reflection of the cooperative's stability and despite the impact of the COVID-19 pandemic, the credit union remains strong and continues to achieve its goals,” said Brian Sherrick, Ideal CU President/CEO. “We thank our members for this continued success and for their loyalty, trust and patience during these uncertain times.”
“The credit union is prepared to face the challenges ahead in the 2021,” said Sherrick. “Our priority remains with our members and ensuring they receive the level of service they have come to expect.”
Members who qualify as VIP+ have the potential to earn two special dividends; the Deposit Rebate Dividend and the Loan Rebate Dividend. Payouts range from $50 to $700 and are based on several factors, including: loan and deposit accounts, balances, interest paid to the credit union, debit card usage and more.
Ideal CU Staff worked one-on-one with members throughout the year to promote the VIP+ Program. Jay Hall, Ideal CU SVP of Branches, applauded their dedication. “Our staff specializes in identifying solutions for our members' financial needs. Naturally, that results in growing relationships and an overall increase in the payouts VIP Plus members receive.”
To learn more about Ideal Credit Union's exclusive VIP+ Program and its qualifications, visit http://www.idealcu.com/vip.
Founded in 1926, Ideal Credit Union is a member owned financial institution that is dedicated to providing financial services driven by a sincere and personal interest in the needs of our employees, members and community. Ideal CU offers a full suite of digital banking products, savings, checking, loans, mortgage, exclusive VIP member payback, business services and more. Offices are located in Eagan, Hugo, Inver Grove Heights, North St. Paul, Stillwater and Woodbury. Visit idealcu.com for details and directions. Equal Housing Lender.
Jason Fihn, Ideal Credit Union, 6517478905, [email protected]
SOURCE Ideal Credit Union
LMRKTS helps banks bridge the SA-CCR adoption gap
NEW YORK and LONDON, Jan. 18, 2021 /PRNewswire/ — LMRKTS, an industry-leading optimization and compression provider, announced the completion of its third optimization cycle for clients who calculate their capital requirements using the Basel Committee on Banking Supervision's Standardized Approach for measuring Counterparty Credit Risk (SA-CCR).
Banks face new challenges in post-trade counterparty exposure management as SA-CCR is being implemented globally. In addition to managing the complexity of new netting sets and a new methodology, banks must continue to optimize and mitigate exposures with counterparties still utilizing the Current Exposure Method (CEM). The phased transition risks the bifurcation of optimization networks and creates additional headwinds for banks' treasury resource management and XVA teams.
Since June 2020, LMRKTS' solution has enabled clients to optimize against a combined network of both CEM and SA-CCR counterparties in a single cycle. “Our innovative approach to holistically managing both methodologies will not only allow the network to remain intact but also grow as additional regions migrate to the SA-CCR framework,” said Andrea Ianniello, President and Chief Commercial Officer of LMRKTS. “This dual objective service is the most recent example of LMRKTS proactively helping our network adapt to the changing regulatory landscape.”
LMRKTS is a leading optimization and compression provider that uses mathematical optimization to help financial institutions manage risks and regulatory capital costs. LMRKTS contributes to the stability of the financial system by reducing capital, balance sheet, and operational costs for its clients. Since the launch of its first commercial service to reduce risk and leverage exposures in G10 currencies, LMRKTS has gone on to eliminate trillions of dollars of obligations between some of the world's largest financial institutions. LMRKTS was founded by former traders and technologists who saw an inefficiency in short term risk management and has received investment from The World Bank and Motive Partners.
One Drop To Work With SCOR And Bayer On Life Insurance Products For People With Chronic Conditions
NEW YORK, Jan. 18, 2021 /PRNewswire/ — One Drop, a leader in digital solutions for people living with diabetes and other chronic conditions, today announced that global partner, Bayer, and SCOR, the fourth-largest global reinsurer, will work to bring One Drop's AI-powered digital health platform to life insurance carriers and policyholders across the United States.
The joint effort among One Drop, SCOR, and Bayer is a shared objective of empowering people to proactively manage their health and reduce the risk of life-threatening complications through innovative products. This objective brings SCOR's in-depth knowledge of the insurance sector and predictive risk assessment underwriting engine, VELOGICA®, together with One Drop's completely personalized continuous and adaptive support experience and predictive capabilities, and Bayer's expertise in the worldwide development and commercialization of health solutions. By incorporating One Drop into a chronic condition-based insurance solution, SCOR intends to improve its underwriting insights and promote a healthier lifestyle.
The partners will develop a customized life insurance solution that pairs SCOR's VELOGICA® with One Drop's evidence-based holistic health programs – delivered entirely through the award-winning mobile app. For people living with diabetes and other chronic conditions, One Drop provides a preventative self-care solution by combining asynchronous coaching, health data tracking, and AI-powered health predictions that provide the right interventions at the right times.
“Aligning the power of proactive prevention with those having incentives to drive long term health is crucial to advancing preventative care versus expensive reactive care. Working together with SCOR and Bayer represents an exciting opportunity to bring our expertise to even more people and advance our mission of transforming health, changing lives, and creating new opportunities for everyone,” said Jeff Dachis, One Drop CEO and founder.
“Bringing together our know-how with that of SCOR and One Drop is an important milestone in Bayer's strategic pursuit to build new and innovative digital business models,” said Jeanne Kehren, Head of Digital and Commercial Innovation and Member of the Executive Committee of Bayer Pharma. “Data-based approaches that focus on the person, not the disease, empower them to effectively influence their healthcare to an unprecedented extent.”
“We are excited to bring the latest state-of-the art digital diabetes management functionality to our life insurance clients and their policyholders, empowering policyholders to manage their chronic conditions efficiently,” said Brona Magee, Deputy CEO of SCOR Global Life. “Research suggests that 29.1 million people in the United States have diabetes and around 1.4 million new cases are diagnosed every year. We believe that empowering patients to manage their chronic conditions can both improve lives and help make life insurance more accessible, thereby providing peace of mind.”
Currently, One Drop supports people in the management of diabetes, pre-diabetes, high blood pressure, high cholesterol, or any combination of these conditions. Last year, Bayer and One Drop announced an agreement to jointly develop digital health products for multiple therapeutic areas in August of 2020. The aim of their partnership is to provide integrated services empowering patients to manage chronic conditions. Additionally, Bayer was lead investor in the company's Series C financing. The partners will explore digital solutions in women's health, oncology, cardiorenal, and other therapeutic areas to provide integrated services that empower people to manage multiple chronic conditions.
In 2020, One Drop surpassed 17 billion longitudinal health data points across 75 biomarkers from millions of users in 195 countries. This immense data wealth powers One Drop's proprietary machine learning, generating physiological predictions (blood sugar levels, blood pressure, etc.) paired with relevant behavioral recommendations. The result is a continuous real-time feedback loop that drives behavior change and improves health outcomes. One Drop's digital health platform has been available to consumers, employers, insurers, and healthcare providers since 2016.
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.com.
SCOR, the world's fourth largest reinsurer, offers its clients a diversified and innovative range of solutions and services to control and manage risk. Applying the “The Art & Science of Risk”, SCOR uses its industry-recognized expertise and cutting-edge financial solutions to serve its clients and contribute to the welfare and resilience of society.
SCOR offers its clients an optimal level of security with its AA- rating from S&P and Fitch. The Group generated premiums of more than EUR 16 billion in 2019 and serves clients in more than 160 countries from its 38 offices worldwide.
For more information, visit: www.scor.com
About One Drop (Informed Data Systems Inc.)
One Drop reimagines possible by harnessing the power of advanced artificial intelligence, clinical science, and behavioral science to transform the lives of people with chronic conditions worldwide. Evidence-based and clinically effective, One Drop's digital health platform delivers one-on-one coaching and personalized health transformation plans that promote positive behavior change and drive outcomes for all individuals, while reducing costs for their insurers, employers, and healthcare providers. For information on helping your payer or employer organization lower the cost of care, contact [email protected] One Drop products and services can be purchased in One Drop's award-winning app (iOS and Android) and at https://onedrop.today,Walmart,Amazon,BestBuy, CVS, and in the Apple Store.
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SOURCE One Drop
Voyager Digital to Present at Noblecon17 and Singular Research
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One Drop To Work With SCOR And Bayer On Life Insurance Products For People With Chronic Conditions
NEW YORK, Jan. 18, 2021 /PRNewswire/ — One Drop, a leader in digital solutions for people living with diabetes and other...
LMRKTS helps banks bridge the SA-CCR adoption gap
NEW YORK and LONDON, Jan. 18, 2021 /PRNewswire/ — LMRKTS, an industry-leading optimization and compression provider, announced the completion of...
Ideal Credit Union Has Paid Its Members Over $4.6 Million as Part of Its Exclusive VIP+ Program
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