|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
In his General Session at DevOps Summit, Asaf Yigal, Co-Founder & VP of Product at Logz.io, explored the value of Kibana 4 for log analysis and provided a hands-on tutorial on how to set up Kibana 4 and get the most out of Apache log files. He examined three use cases: IT operations, business intelligence, and security and compliance. Asaf Yigal is co-founder and VP of Product at log analytics software company Logz.io. In the past, he was co-founder of social-trading platform Currensee, which...
Nov. 25, 2015 06:45 PM EST Reads: 128
Container technology is shaping the future of DevOps and it’s also changing the way organizations think about application development. With the rise of mobile applications in the enterprise, businesses are abandoning year-long development cycles and embracing technologies that enable rapid development and continuous deployment of apps. In his session at DevOps Summit, Kurt Collins, Developer Evangelist at Built.io, examined how Docker has evolved into a highly effective tool for application del...
Nov. 25, 2015 05:00 PM EST Reads: 299
Discussions of cloud computing have evolved in recent years from a focus on specific types of cloud, to a world of hybrid cloud, and to a world dominated by the APIs that make today's multi-cloud environments and hybrid clouds possible. In this Power Panel at 17th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the importance of customers being able to use the specific technologies they need, through environments and ecosystems that expose their APIs to make true ...
Nov. 25, 2015 04:15 PM EST Reads: 473
In recent years, at least 40% of companies using cloud applications have experienced data loss. One of the best prevention against cloud data loss is backing up your cloud data. In his General Session at 17th Cloud Expo, Sam McIntyre, Partner Enablement Specialist at eFolder, presented how organizations can use eFolder Cloudfinder to automate backups of cloud application data. He also demonstrated how easy it is to search and restore cloud application data using Cloudfinder.
Nov. 25, 2015 03:45 PM EST
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York and Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty ...
Nov. 25, 2015 02:45 PM EST Reads: 493
Internet of @ThingsExpo, taking place June 7-9, 2016 at Javits Center, New York City and Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 18th International @CloudExpo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo New York Call for Papers is now open.
Nov. 25, 2015 02:30 PM EST Reads: 505
The cloud. Like a comic book superhero, there seems to be no problem it can’t fix or cost it can’t slash. Yet making the transition is not always easy and production environments are still largely on premise. Taking some practical and sensible steps to reduce risk can also help provide a basis for a successful cloud transition. A plethora of surveys from the likes of IDG and Gartner show that more than 70 percent of enterprises have deployed at least one or more cloud application or workload. Y...
Nov. 25, 2015 02:15 PM EST Reads: 424
Cloud computing delivers on-demand resources that provide businesses with flexibility and cost-savings. The challenge in moving workloads to the cloud has been the cost and complexity of ensuring the initial and ongoing security and regulatory (PCI, HIPAA, FFIEC) compliance across private and public clouds. Manual security compliance is slow, prone to human error, and represents over 50% of the cost of managing cloud applications. Determining how to automate cloud security compliance is critical...
Nov. 25, 2015 02:00 PM EST Reads: 352
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Day 2 Keynote at 17th Cloud Expo, San...
Nov. 25, 2015 02:00 PM EST Reads: 509
As organizations shift towards IT-as-a-service models, the need for managing & protecting data residing across physical, virtual, and now cloud environments grows with it. CommVault can ensure protection & E-Discovery of your data - whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise.
Nov. 25, 2015 01:45 PM EST
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
Nov. 25, 2015 01:30 PM EST Reads: 464
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi’s VP Business Development and Engineering, explored the IoT cloud-based platform technologies driving t...
Nov. 25, 2015 12:00 PM EST Reads: 362
There are over 120 breakout sessions in all, with Keynotes, General Sessions, and Power Panels adding to three days of incredibly rich presentations and content. Join @ThingsExpo conference chair Roger Strukhoff (@IoT2040), June 7-9, 2016 in New York City, for three days of intense 'Internet of Things' discussion and focus, including Big Data's indespensable role in IoT, Smart Grids and Industrial Internet of Things, Wearables and Consumer IoT, as well as (new) IoT's use in Vertical Markets.
Nov. 25, 2015 12:00 PM EST Reads: 516
The Internet of Things (IoT) is growing rapidly by extending current technologies, products and networks. By 2020, Cisco estimates there will be 50 billion connected devices. Gartner has forecast revenues of over $300 billion, just to IoT suppliers. Now is the time to figure out how you’ll make money – not just create innovative products. With hundreds of new products and companies jumping into the IoT fray every month, there’s no shortage of innovation. Despite this, McKinsey/VisionMobile data...
Nov. 25, 2015 10:00 AM EST Reads: 428
We all know that data growth is exploding and storage budgets are shrinking. Instead of showing you charts on about how much data there is, in his General Session at 17th Cloud Expo, Scott Cleland, Senior Director of Product Marketing at HGST, showed how to capture all of your data in one place. After you have your data under control, you can then analyze it in one place, saving time and resources.
Nov. 25, 2015 09:45 AM EST Reads: 115