|By PR Newswire||
|March 17, 2014 06:01 AM EDT||
MONROVIA, Calif., March 17, 2014 /PRNewswire/ -- STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses for the eye and delivery systems reported that its Visian Toric Implantable Lens or TICL received favorable votes to three questions presented to the U.S. Food and Drug Administration's (FDA) Ophthalmic Devices Panel of the Medical Devices Advisory Committee. The Ophthalmic Devices Panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational devices for use in the eye and makes recommendations to the Commissioner of Food and Drugs.
The Panel voted favorably on all three questions posed to it by the FDA's Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices:
- Is there reasonable assurance that the Visian Toric Implantable Collamer Lens is safe for use in patients who meet the criteria specified in the proposed indication?
- Is there reasonable assurance that the Visian Toric Implantable Collamer Lens is effective for use in patients who meet the criteria specified in the proposed indication?
- Do the benefits of the Visian Toric Implantable Collamer Lens for use in patients who meet the criteria specified in the proposed indication outweigh the risks for use in patients who meet the criteria specified in the proposed indication?
"The FDA, the Panel members, and the STAAR team spent a great deal of time preparing for the Visian TICL panel session," said Barry Caldwell, President & CEO. "We went into the panel session understanding and acknowledging that the data under review from the trial study was more than 10 years old and subject to rigorous review. We appreciate both the FDA's and the Panel's work to understand the data and clinical evidence we were able to provide regarding the Visian TICL's safety and efficacy for patients with myopia and astigmatism. Additionally, we are grateful to the physicians who have worked extensively with our team throughout this process to provide valuable presentations to the Panel on the Visian TICL. We also appreciate the valuable testimony provided by physicians during the open public hearing who gave time from their practices to participate in the meeting. The STAAR team looks forward to working with the FDA to complete the process to make the Visian TICL available to surgeons and patients in the U.S."
Surgeons presenting during the Company's session to provide support for the TICL approval included: Dr. John Vukich from the Davis Duehr Dean Medical Center, Dr. Steven Schallhorn who is Medical Director for Optical Express, Dr. Robert Rivera from Hoopes Vision and Dr. Francis Price from the Price Vision Group. Surgeons presenting during the open public hearing session included: Dr. Manus Kraff, Dr. Paul Dougherty, Dr. David Schneider, Dr. Paul Harton and Dr. Gregory Parkhurst. In addition, Mr. Richard Ferguson, the father of a son who is in need of the technology, testified during the public session.
The Visian Toric ICL is a refractive phakic implant placed in the posterior chamber of the eye between the iris and the natural crystalline lens. It shares the same unique, foldable design as STAAR Surgical's Visian ICL. The difference between the two is the toric optical feature of the Visian Toric ICL is designed to permit the surgeon to correct both myopia and astigmatism in a single procedure. There is no currently approved phakic IOL in the U.S. for the correction of astigmatism. In the over 60 markets in which the Visian ICL and TICL are in commercial use approximately 40% of the units and approximately 50% of the revenue are the TICL version.
The FDA approved STAAR Surgical's Visian ICL in December 2005 to treat myopia in adults and the Company began commercial sales in the U.S. in 2006. The lens has gained acceptance in the U.S. market since its introduction STAAR's Toric ICL clinical trial included 210 eyes in 124 patients with a mean myopia of -9.37D and a mean astigmatism of +1.95D and an average age of 35. The 12 month clinical outcomes show that 82% of the eyes were 20/20 or better uncorrected and 54% of the eyes were 20/16 or better.
The proposed indications for use of the Visian TICL, as presented during the panel meeting, was as follows:
- for the correction of myopic astigmatism in adults 21-45 years with spherical equivalent ranging from -3.0D to ≤ -15.0D with cylinder of 1.0D to 4.0D;
- for the reduction of myopic astigmatism in adults 21-45 years with spherical equivalent ranging from greater than -15.0D to -20.0D with cylinder 1.0D to 4.0D;
- fith an anterior chamber depth (ACD) of 3.0 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5 Diopter for 1 year prior to implantation); and
- the Visian TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye.
About STAAR Surgical
STAAR, which has been dedicated solely to ophthalmic surgery for over 25 years, designs, develops, manufactures and markets implantable lenses for the eye and delivery systems therefor. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. STAAR's lens used in refractive surgery as an alternative to LASIK is called an Implantable Collamer® Lens or "ICL." A lens used to replace the natural lens after cataract surgery is called an intraocular lens or "IOL." More than 400,000 Visian ICLs have been implanted to date; to learn more about the ICL go to: www.visianinfo.com. STAAR has approximately 335 full time employees and markets lenses in over 60 countries. Headquartered in Monrovia, CA, it manufactures in the following locations: Nidau, Switzerland; Aliso Viejo, CA; and Monrovia, CA. For more information, please visit the Company's website at www.staar.com.
All statements in this press release that are not statements of historical fact are forward-looking statements, including statements about any of the following: any projections of financial items; the potential future performance of the company or its products, such potential sales of the Visian TICL in the U.S. or prospects for achieving such potential future performance; and statements regarding expectations for future success. Important additional factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in the company's Annual Report on Form 10-K for the year ended January 3, 2014, under the caption "Risk Factors," which is on file with the Securities and Exchange Commission and available in the "Investor Information" section of the company's website under the heading "SEC Filings."
These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements.
Doug Sherk, 415-652-9100
Leigh Salvo, 415-568-9348
SOURCE STAAR Surgical
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportuni...
Aug. 24, 2016 08:00 AM EDT Reads: 3,804
Using new techniques of information modeling, indexing, and processing, new cloud-based systems can support cloud-based workloads previously not possible for high-throughput insurance, banking, and case-based applications. In his session at 18th Cloud Expo, John Newton, CTO, Founder and Chairman of Alfresco, described how to scale cloud-based content management repositories to store, manage, and retrieve billions of documents and related information with fast and linear scalability. He addres...
Aug. 24, 2016 08:00 AM EDT Reads: 1,793
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.
Aug. 24, 2016 07:45 AM EDT Reads: 2,047
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Aug. 24, 2016 07:15 AM EDT Reads: 1,638
Aspose.Total for .NET is the most complete package of all file format APIs for .NET as offered by Aspose. It empowers developers to create, edit, render, print and convert between a wide range of popular document formats within any .NET, C#, ASP.NET and VB.NET applications. Aspose compiles all .NET APIs on a daily basis to ensure that it contains the most up to date versions of each of Aspose .NET APIs. If a new .NET API or a new version of existing APIs is released during the subscription peri...
Aug. 24, 2016 07:15 AM EDT Reads: 1,776
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Aug. 24, 2016 07:00 AM EDT Reads: 1,726
DevOps at Cloud Expo, taking place Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long dev...
Aug. 24, 2016 05:00 AM EDT Reads: 2,049
Amazon has gradually rolled out parts of its IoT offerings in the last year, but these are just the tip of the iceberg. In addition to optimizing their back-end AWS offerings, Amazon is laying the ground work to be a major force in IoT – especially in the connected home and office. Amazon is extending its reach by building on its dominant Cloud IoT platform, its Dash Button strategy, recently announced Replenishment Services, the Echo/Alexa voice recognition control platform, the 6-7 strategic...
Aug. 24, 2016 04:30 AM EDT Reads: 2,163
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Aug. 24, 2016 03:30 AM EDT Reads: 2,904
Akana has announced the availability of version 8 of its API Management solution. The Akana Platform provides an end-to-end API Management solution for designing, implementing, securing, managing, monitoring, and publishing APIs. It is available as a SaaS platform, on-premises, and as a hybrid deployment. Version 8 introduces a lot of new functionality, all aimed at offering customers the richest API Management capabilities in a way that is easier than ever for API and app developers to use.
Aug. 24, 2016 02:00 AM EDT Reads: 1,393
Kubernetes, Docker and containers are changing the world, and how companies are deploying their software and running their infrastructure. With the shift in how applications are built and deployed, new challenges must be solved. In his session at @DevOpsSummit at19th Cloud Expo, Sebastian Scheele, co-founder of Loodse, will discuss the implications of containerized applications/infrastructures and their impact on the enterprise. In a real world example based on Kubernetes, he will show how to ...
Aug. 24, 2016 01:45 AM EDT Reads: 1,257
Personalization has long been the holy grail of marketing. Simply stated, communicate the most relevant offer to the right person and you will increase sales. To achieve this, you must understand the individual. Consequently, digital marketers developed many ways to gather and leverage customer information to deliver targeted experiences. In his session at @ThingsExpo, Lou Casal, Founder and Principal Consultant at Practicala, discussed how the Internet of Things (IoT) has accelerated our abil...
Aug. 24, 2016 01:45 AM EDT Reads: 1,853
With so much going on in this space you could be forgiven for thinking you were always working with yesterday’s technologies. So much change, so quickly. What do you do if you have to build a solution from the ground up that is expected to live in the field for at least 5-10 years? This is the challenge we faced when we looked to refresh our existing 10-year-old custom hardware stack to measure the fullness of trash cans and compactors.
Aug. 24, 2016 01:00 AM EDT Reads: 1,577
SYS-CON Events announced today that Isomorphic Software will exhibit at DevOps Summit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Isomorphic Software provides the SmartClient HTML5/AJAX platform, the most advanced technology for building rich, cutting-edge enterprise web applications for desktop and mobile. SmartClient combines the productivity and performance of traditional desktop software with the simp...
Aug. 24, 2016 12:45 AM EDT Reads: 2,053
The emerging Internet of Everything creates tremendous new opportunities for customer engagement and business model innovation. However, enterprises must overcome a number of critical challenges to bring these new solutions to market. In his session at @ThingsExpo, Michael Martin, CTO/CIO at nfrastructure, outlined these key challenges and recommended approaches for overcoming them to achieve speed and agility in the design, development and implementation of Internet of Everything solutions wi...
Aug. 24, 2016 12:30 AM EDT Reads: 1,856