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Article Date: 8/1/2011

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MGD Treatment Device Obtains FDA Approval
NEWS spectrum

MGD Treatment Device Obtains FDA Approval

TearScience, Inc. has received U.S. Food and Drug Administration (FDA) clearance for its LipiFlow Thermal Pulsation System for treating meibomian gland dysfunction (MGD), also known as evaporative dry eye. The clearance enables TearScience to market and sell LipiFlow to eyecare physicians in the United States. Lipi-Flow will be available immediately but on a limited basis in the United States through the end of 2011. LipiFlow removes meibomian gland obstructions by applying directed energy to a patient's eyelid during a 12-minute in-office treatment.

“Now, with FDA clearance to market the LipiFlow, TearScience provides a new, innovative alternative treatment that delivers effective relief for many patients who desperately need it,” said Dr. Alan N. Carlson, chief of the Corneal, External Disease, and Refractive Surgery Service at the Duke Eye Center in Durham, N.C.

TearScience gained FDA clearance by demonstrating the safety and effectiveness of Lipi-Flow through a U.S.-based, nine-center, randomized controlled clinical trial for the treatment of evaporative dry eye.

TearScience will sell its LipiFlow and Lipi-View Ocular Surface Interferometer devices as a system for eyecare practices. The LipiView enables physicians to visualize the eye's tear film.

B+L Initiates Voluntary Recall of OTC Drops

Bausch + Lomb (B+L) is conducting a voluntary recall of a single lot of Murocel Methyl-cellulose Lubricant Ophthalmic Solution, USP 1%, based on routine stability testing that showed the single lot was out of specification for preservative efficacy.

There have been no adverse events reported attributed to the single product lot with the expiration date 1-31-2012. Potential adverse events may include eye pain, change in vision, redness or irritation of the eye, or ocular infection.

Murocel Methylcellulose Lubricant Ophthalmic Solution, USP 1% is available only in the United States.

B+L has directly contacted retailers in the United States who have been shipped this product to initiate the recall and inform them of the steps they should take to return the product to the company. B+L also alerted eyecare practitioners to the recall.

The company is asking consumers who possess the affected single lot to call the customer service center for instructions on returning and reimbursement at (800) 553-5340.

GPLI to Hold Symposium

The Gas Permeable Lens Institute (GPLI) will hold GP Lens Practice... Today and Tomorrow, an in-depth clinical symposium featuring the latest advancements in the GP lens industry, this fall. Ten experts and practitioners in the GP field will share important clinical pearls as well as practical applications for your practice to increase your comfort level in fitting spherical and specialty design lenses. Participants may earn up to seven hours of educational credit (COPE approval pending).

The symposium will take place at Hamburger University, adjacent to the Hyatt Lodge in Oakbrook, Ill., a suburb of Chicago, on Oct. 23, 2011. The day will begin with a general session on the topic of “Advancements in GP Lens Applications and Materials.” Then each hour, attendees will be able to select from among two different tracks of courses depending on their practice needs. The symposium will conclude with a special two-hour case grand rounds program, with the management of representative cases pertaining to spherical and specialty GP contact lens applications.

For more information or to register, visit www.GPLI.info.

AOF and Vistakon Present Awards

The American Optometric Foundation (AOF) announced the 2011 Vistakon Award of Excellence in Contact Lens Patient Care recipients. This award recognizes fourth-year student clinicians who have demonstrated excellent overall knowledge of the contact lens field plus skillful, considerate, and professional care of contact lens patients during their optometric education. Each winner will receive a $1,000 award and personalized plaque.

“I would like to express our appreciation to Vistakon for their continuous support of the AOF and also to congratulate the receipts of the Vistakon Award of Excellence in Contact Lens Care,” said Catherine S. Amos, OD, FAAO, AOF president.

The recipients are: Stefanie Ratermann, OD, Illinois College of Optometry; Colby Fletcher, OD, Indiana University at Bloomington School of Optometry; Charlie C. Dao, OD, Inter-American University of Puerto Rico School of Optometry; Lauren Evonne Quaine, OD, Michigan College of Optometry at Ferris State University; Yin-Yin Aung, OD, New England College of Optometry; Natalie Cathy Pham, OD, Northeastern State University Oklahoma College of Optometry; Brian Paul, OD, Nova Southeastern University College of Optometry; Brittany Nelson, OD, Pacific University College of Optometry; Lindsey Beth Barouh, OD, Pennsylvania College of Optometry at Salus University; Veronica Woi, OD, Southern California College of Optometry; Katherine Paulsen, OD, Southern College of Optometry; Dana Beth Pollack, OD, State University of New York College of Optometry; Joseph S. Conrad, OD, The Ohio State University College of Optometry; Sheila Karst Morris, OD, University of Alabama at Birmingham School of Optometry; Pam Satjawatcharaphong, OD, University of California-Berkeley School of Optometry; Katie Wicks, OD, University of Houston College of Optometry; Derek Wiles, OD, University of Missouri-St. Louis College of Optometry; Richard Wardé, OD, University of Montreal School of Optometry; Tanya Marie Polonenko, OD, University of Waterloo School of Optometry.

Acculens Expands Scleral Design

Earlier this year, Acculens announced the release of extended parameters for its Maxim Scleral lens. Specifically, the lens is now available in diameters of 16.0mm and 17.5mm.

“With addition of our new 17.5mm lens, practitioners will now be able to manage severe keratoconus, excessively steep bulging transplants and pellucid patients more efficiently,” said Accu-lens CEO Bill Masler.

The Maxim Scleral lens is indicated for managing corneal distortion and dry eyes. It is available in custom parameters manufactured in Boston XO2 material (Bausch + Lomb). Twenty-lens trial lens sets are available free of charge. For more information contact Acculens at (800) 525-2470 or visit www.acculens.com.

Duette Parameters Expanded
Earlier this year, SynergEyes, Inc. expanded the parameters of its Duette silicone hydrogel hybrid contact lens for astigmatism. Duette is now available in sphere powers from +6.00D to –15.00D. This represented the first of additional parameter expansions planned for Duette for 2011, according to the company.

Blanchard Launches Education Program
The Blanchard Contact Lens Research and Professional Development Center in Manchester, N.H., hosted its inaugural session featuring the company's MSD Mini Scleral Design on Saturday, June 25, 2011.
The BCL Research and Professional Development Center was designed to provide up-to-the-minute fitting techniques in a small group setting that included hands-on, practical learning joined with state-of-the-art digital imaging equipment. The session was limited to eight attendees to maintain quality.
Session agenda included: tour of the Blanchard Contact Lens laboratory and lens production; in-depth presentation of the MSD Mini Scleral Design lens with Stephen Byrnes, OD; hands-on workshop, learning and practicing techniques for applying and removing lenses in the wet lab with Dr. Byrnes; viewing and actively participating in a series of patient fits with Dr. Byrnes.
“Application and removal of the scleral lens designs can be intimidating for lens fitters and their patients,” stated Dr. Byrnes.
Blanchard plans to host additional sessions in August, September, and October. Those wishing to attend should contact their Blanchard Sales Representative to discuss availability. Visit Blanchard Contact Lens on the web at www.blanchardlab.com or call (800) 367-4009.

Conforma Offers New VFL3 Multifocal Options
In 2007, Conforma Contact Lenses added HD-Optics to its VFL3 Multifocal, a front-surface technology that minimizes aberrations and maximizes optical quality, according to Conforma. Conforma recently added VFL3 with HD-AP for advanced presbyopes, which will extend the add power range to better accommodate those patients who have higher add demands. This aspheric front surface provides a junctionless progression of increasing add power from the optical center to the intermediate and peripheral areas of the optical zone. Conforma states that this progressive power change results in 360 degrees of functional distance, intermediate, and near vision. Conforma recommends Boston XO material (Bausch + Lomb) and its plasma cleaning for the lens. Visit www.conforma.com for a free warranty coupon.

WEB UPDATE
New Site for Searching Soft Contact Lenses
Lensfindr, LLC has launched www.lensfindr.com, a web-based software program that will allow contact lens clinicians to search and select specific soft contact lens information for their patients. Multiple fields allow a customized search process. Lensfindr stated that the database will include lenses primarily from Bausch + Lomb, Ciba Vision, CooperVision, and Vistakon. A select number of specialty contact lens companies will be included and revised as per demand by the users. The site will also feature other useful contact lens information including a manufacturer's directory, solution charts, GP lens information, contact lens products, and industry/news updates.

ABB Concise Updates Yourlens.com
ABB Concise, with the goal of bringing more patients to its accounts' yourlens.com-powered Web stores, has changed the yourlens.com Web site to include patient eyecare information and a new Doctor Locator search engine. According to the company, practitioners that utilize yourlens.com can remain competitive by lowering their transaction costs and making it easier for their patients to obtain lenses. ABB Concise's yourlens.com service provides an Internet reorder functionality that is easy to graft onto existing practice Web sites. The service can also be used as a stand-alone Internet reorder site. Other free web store enhancements include: Patient Enrollment, Find a Doctor Feature, Exam Recall Reminders, Patient Activity Reports, and Patient AutoShip.

INDUSTRY BRIEFS
■ On July 7th, the contact lens profession lost a true pioneer with the passing of Charles H. May, OD, FAAO, FIOS, at the age of 89. He received his optometry degree from the Illinois College of Optometry. Affectionally termed the “Grandfather” of orthokeratology, Dr. May was responsible for many of the early research procedures and success of orthokeratology. With Dr. Stuart Grant, they collaborated on the very popular and often-used “May-Grant” approach to fitting orthokeratology lenses. His innovations in the research and development of contact lenses spanned over 50 years.
Fera Pharmaceuticals recently launched Garamycin (gentamicin sulfate) Ophthalmic Solution USP, a broad spectrum anti-infective indicated for treating ocular bacterial infections such as conjunctivitis, keratitis, and blepharitis. The company says that Garamycin is a trusted brand name and the product is a favorite among physicians who are looking for a single ingredient anti-infective ophthalmic solution.
■ Practice management software system Practice Maximus (Diversified Ophthalmics, Inc.) was recently certified by Drummond Group Inc., an ONC-ATCB (Office of the National Coordinator—Authorized Testing and Certification Bodies) as a Complete Electronic Health Records software system. The Practice Maximus EHR module is available to all Practice Maximus users at no charge. The certified EHR version is an upgrade option that allows practices to achieve the 2011/2012 criteria for Stage 1. This is necessary to be eligible for CMS Incentive programs and to avoid penalties in future years.
Bausch + Lomb (B+L) has announced plans to launch a pharmaceutical business in India through a strategic agreement with Micro Labs, a leading provider of quality healthcare products. The partnership will provide B+L with high-quality manufacturing capabilities in the region that will speed the introduction of new prescription and over-the-counter medicines targeted at a wide range of eye diseases. Through the agreement with Micro Labs, B+L aims to capture part of the rapidly expanding ophthalmic pharmaceuticals market in India, which is expected to reach U.S. $300 million by 2015.
ABB Concise has endorsed Optometry Giving Sight (OGS) as its International Charity of Choice and will be recognized by the organization as a Gold National In Kind Sponsor. OGS also recently recognized AllAboutVision.com as a National Gold Sponsor in the United States and named Amir Khoshnevis, OD, as the organization's Philanthropist of the Year.
■ As part of its Sharing Vision Grant Program, this summer SynergEyes, Inc. partnered with Dr. David Sweeney at Insight Your Vision Source to provide Denise Filmore with a free professional contact lens fitting and a free pair of SynergEyes ClearKone lenses. Ms. Filmore, a keratoconus patient, is a single mother without insurance who has a special needs child and was unable to afford ClearKone lenses. The Sharing Vision Grant Program was created to bring the technologically advanced ClearKone hybrid contact lens to irregular cornea patients who may otherwise not have access.
Prevent Blindness America (PBA) has launched the “Most Beautiful Eyes Contest.” The contest allows children across the United States the chance to become the face of the Star Pupils program in 2012 and to win a $25,000 scholarship. Through Aug. 31, 2011, parents of children ages zero to 17 are encouraged to enter their child in the contest by submitting a photo to the Prevent Blindness America Facebook page at facebook.com/preventblindness. The program is designed to support the Star Pupils program, the signature vision and education platform for PBA.
■ In KwaZulu-Natal (KZN), South Africa, the one millionth patient recently received an eye exam and the eye care needed thanks to a program initiative of partners: the International Centre for Eyecare Education (ICEE), Standard Chartered Bank, KwaZulu-Natal Department of Health, and Optometry Giving Sight. The Giving Sight to KwaZulu-Natal program started in July 2007 with the objective of providing accessibility of eye care services to communities throughout the province using the existing public health system.


Contact Lens Spectrum, Issue: August 2011

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