NEWSspectrum
FDA Approves Xiidra
Shire plc announced that the U.S. Food and Drug Administration (FDA) has approved Xiidra (lifitegrast ophthalmic solution) 5%, a twice-daily eye drop solution indicated for the treatment of the signs and symptoms of dry eye disease in adult patients. Shire expects to launch Xiidra in the United States in the third quarter of 2016.
Xiidra is dosed twice per day, approximately 12 hours apart, in each eye. The safety and efficacy of Xiidra was studied in 1,181 patients (of which 1,067 patients received lifitegrast 5%) in four placebo-controlled, 12-week trials. Each of the four studies assessed the effect of Xiidra on both the signs and symptoms of dry eye disease at baseline and at weeks two, six, and 12.
Assessment of symptoms was based on change from baseline in patient-reported eye dryness score (EDS; 0-100 visual analogue scale). Assessment of signs was based on inferior corneal staining score (ICSS; 0-4 scale). In all four studies, a larger reduction in EDS was observed with Xiidra at six and 12 weeks. In two of the four studies, an improvement in EDS was seen with Xiidra at two weeks. At week 12, a larger reduction in ICSS favoring Xiidra was observed in three of the four studies.
The most common adverse reactions reported in 5% to 25% of patients were instillation site irritation, altered taste sensation (dysgeusia), and reduced visual acuity.
Meeting Focused on Scleral Lenses Announced
A research meeting focused on scleral GP lenses is set to debut later this year. The International Forum for Scleral Lens Research (IFSLR) is scheduled for Monday, Dec. 5, 2016, by the Texas Eye Research and Technology Center, University of Houston College of Optometry.
The IFSLR will follow the 33rd Annual Cornea, Contact Lens & Contemporary Vision Care Symposium on Saturday and Sunday, Dec. 3 to 4, 2016, at The Westin Houston Hotel, Memorial City. IFSLR is an open meeting where practitioners and laboratories interested in the latest developments and research are invited to attend this first annual symposium dedicated exclusively to research-supported presentations by some of the best-known experts working in the scleral lens field today.
Like all contact lens modalities, scleral lenses come with their own set of unique challenges, such as midday fogging, conjunctival prolapse, handling difficulties, and potential corneal edema issues, to name a few. Furthermore, there is no consensus on the ideal size or vault of scleral lenses or how the lens specifications should be expressed, either in base curve or sagittal depth measurements or both. For this field to move forward, there is a tremendous need for evidence-based information. This is the purpose of IFSLR, and this is what invited leading researchers will discuss—what current research has shown and what directions of research are needed for future progress.
The IFSLR is governed by a Scientific Executive Committee consisting of Chair Jan Bergmanson, Melissa Barnett, Thomas Arnold, Ralph Stone, William Miller, Jan Svochak, and John Hibbs. The IFSLR is supported by the experienced University of Houston College of Optometry educational meeting administration led by Marcus Piccolo, Jennifer Ebert, and Amanda Johnson.
This meeting is sponsored by Art Optical Contact Lens, Bausch + Lomb, Contamac, Essilor, Metro Optics, and TruForm Optics.
AAO Announces 2016 Award Recipients
Each year, the American Academy of Optometry recognizes distinguished individuals who have made countless contributions to advancing the profession of optometry. The 2016 recipients include: Martin S. Banks, MA, PhD, Charles F. Prentice Medal and Lecture Award; Erica Fletcher, OD, PhD, FAAO, Glenn A. Fry Award and Lecture (American Optometric Foundation Award); Nimesh Patel, OD, PhD, FAAO, Irvin M. and Beatrice Borish Award; Wolfgang Cagnolati, MS, DSc, FAAO, AAO-Essilor Award for Outstanding International Contributions to Optometry; Rachel “Stacey” Coulter, OD, FAAO, William Feinbloom Award; Kelly Moore, OD, MS, Julius F. Neumueller Award in Optics (American Optometric Foundation Award); Richard London, MA, OD, FAAO, Vincent Ellerbrock Clinician Educator Award; Anthony J. Adams, OD, PhD, FAAO, and Thomas L. Lewis, OD, PhD, FAAO, Life Fellow Award; Ying Hon, BSc(Hons)Optom, and Andrew K. C. Lam, PhD, MPhil, FAAO, Garland W. Clay Award; Timothy B. Edrington, OD, MS, FAAO, Michael G. Harris Award for Excellence in Optometric Education (American Optometric Foundation Award). The awards of the Section on Cornea, Contact Lenses & Refractive Technologies include: Perry Rosenthal, MD, Max Schapero Memorial Lecture Award; and Alan Tomlinson, MSc, PhD, DSc, Founders’ Award. The award of the Public Health & Environmental Vision Section is awarded to Kovin Naidoo, OD, PhD, FAAO, Henry B. Peters Memorial Award in Public Health and Environmental Vision.
Winners will be recognized at the Academy 2016 Anaheim Awards Ceremony on Nov. 11. Section on Cornea, Contact Lenses and Refractive Technologies awards will be given on Nov. 9. The Henry B. Peters Memorial Award will be given on Nov. 10.
Alcon Announces Launch of DT1 Multifocal
Alcon recently announced the introduction of Dailies Total1 Multifocal contact lenses. This multifocal lens combines the comfort of the company’s Dailies Total1 water gradient lens technology with the Precision Profile lens design, a design also included in Alcon’s Air Optix Aqua and Dailies AquaComfort Plus multifocal contact lenses.
Dailies Total1 Multifocal lenses are currently available through a limited number of accounts in the United States, with a nationwide rollout expected on Sept. 1. Additional lens details will appear in a future Product Spectrum.
ABB Optical Data Shows Daily Disposables Growing
As a distributor of optical products servicing two-thirds of practicing optometrists nationwide, ABB Optical Group is a leading resource for identifying industry trends and projecting areas of future growth.
The following insights are reflective of ABB Optical Group’s data on daily disposable contact lenses:
• The daily disposables market in the United States is underdeveloped. Without adding a single new patient, the U.S. optical industry has the potential to add $1 billion in incremental revenue if it were to reach global averages of daily disposable sales.
• A patient fit in an annual supply of daily disposables will typically drive 2.6 times more practice revenue than would a patient fit in a reusable lens.
• A practice that harnesses opportunities in fitting daily disposable lenses will grow rapidly. A 10 point upward shift in daily disposable sales, such as growing daily disposable sales from 25% to 35% of a practice’s overall sales, can increase a practice’s overall total revenue by as much as 16% without adding a single new patient.
• The wholesale market for daily disposables in the United States was up 22% in 2015, with accelerating growth each quarter. Year-to-date growth has reached more than 28%.
• Daily disposables are now the most popular modality of prescribed contact lenses, representing 37% of overall sales among independent eyecare practitioners.
The company predicts an industry-wide shift within the next six months reflecting daily disposables as the leading contact lens modality in the United States.
Jason Jedlicka Joins B+L as a Consultant
Jason Jedlicka, OD, FAAO, FSLS, FCLSA, clinical associate professor at Indiana University School of Optometry and director of the Cornea and Contact Lens Service, has joined the Bausch + Lomb (B+L) Specialty Vision Products business as an independent consultant. Dr. Jedlicka brings more than 20 years of academic and private practice experience in customized contact lenses. In this new role, he will be responsible for working with the B+L marketing and research and development teams to develop novel customized contact lens designs to further enhance the company’s specialty lens product line. He will also provide support to eyecare professionals through lecturing and fitting instruction during educational events in partnership with Lynette Johns, OD, a global expert in scleral lenses, on the B+L Specialty Vision Products team.
Dr. Jedlicka is a diplomate in the American Academy of Optometry’s Cornea, Contact Lens, and Refractive Technologies section, a past president of the Scleral Lens Education Society, and a fellow and board member of the Contact Lens Society of America. Dr. Jedlicka has also lectured internationally and written many articles and book chapters on contact lenses and anterior segment disease.
OD/MBA Degree Program Opens
The University of Alabama at Birmingham (UAB) has added a dual Doctor of Optometry and Master of Business Administration degree—the first of its kind nationwide. The Collat School of Business has partnered with UAB’s School of Optometry to develop a program aiming to provide OD/MBA graduates the best possible trajectory to gain employment within the healthcare field through providing them with a greater understanding of the business of eye care.
The new dual-degree program will give optometry students the training and education to better understand the business side of the healthcare field through providing courses in accounting and finance, economics, marketing, management, operations, and supply chain management, information technology, and business strategy, with a focus on health care.
UAB’s OD/MBA program is accepting applicants for the summer of 2017 for first-year optometry students. Current optometry students who are interested in matriculating into the program, including students who are already completing MBA coursework, are also invited to apply.
OcuSoft Turns 30
OcuSoft Inc. is celebrating its 30th year providing technological solutions that optimize the delivery and performance of ophthalmic pharmaceutical products, particularly in the area of ocular surface disease. OcuSoft has served the ophthalmic industry with a unique selection of proprietary brands since 1986.
As a natural extension to the company’s successful operations, it has expanded into skin care with a full line of products specially developed for patients who have sensitive eyes.
Blanchard to Hold Fall Scleral Workshop Tour
Blanchard Contact Lenses has released the cities and dates for its fall Beyond the Limbus Scleral Lens Workshop tour. The Beyond the Limbus workshops, in their sixth year, are a component of Blanchard University, Blanchard’s educational division.
Registrations are now being accepted for the following workshops:
• Sept. 11: Manchester, NH
• Oct. 2: New Orleans
• Oct. 9: Scottsdale, AZ
• Oct. 16: Denver
• Oct. 23: Atlantic City, NJ
• Oct. 30: San Antonio, TX
• Nov. 6: Newport Beach, CA
Blanchard will also be discussing its new Onefit Asian design lenses as well as XLC—the new Extra Limbal Clearance option for its Onefit lenses.
Practitioners wishing to attend a Beyond the Limbus workshop can register at www.blanchardlab.com, by calling (800) 367-4009, or by contacting their respective Blanchard sales representative. Space is limited.
University Education Challenge Winner Named
The University of the Incarnate Word (UIW) Rosenberg School of Optometry won the first University Education Challenge, a program hosted by ABB Optical and Paragon Vision Sciences to support the optometrists of tomorrow.
The San Antonio, TX-based school, which competed against six other colleges, received a $5,000 unrestricted educational grant. UIW won based on the attendance and survey results of a webinar created and presented by third-year student Amy Belloli-Conner. Faculty members Dr. Farshid Amir and Dr. William Miller oversaw her efforts.
Belloli-Conner’s webinar focused on the importance of contact lens cleaning and compliance after physical activities such as mud runs, color runs, and water slide adventures.
ABB Optical announced UIW as the winning college at the 2016 Association of Optometric Contact Lens Educators (AOCLE) meeting in June. In addition to the $5,000 grant presented to the college, ABB Optical and Paragon Vision Sciences also awarded $500 to Belloli-Conner. For more information, visit ABBconcise.com/UniversityChallenge.
Avedro Receives Additional CXL Indication
Avedro, Inc. received approval from the U.S. Food and Drug Administration (FDA) for Photrexa Viscous, Photrexa, and the KXL System used in corneal collagen cross-linking for the treatment of corneal ectasia following refractive surgery, the products’ second indication. Avedro’s photoenhancers, Photrexa Viscous and Photrexa, used in conjunction with the KXL System, received an initial indication for the treatment of progressive keratoconus in April 2016 and remain the first and only corneal collagen cross-linking therapy approved in the United States. The Photrexa formulations and the KXL System are expected to be available for qualifying patients through their ophthalmologists before the end of this year.
The FDA approval was based on Avedro’s NDA submission, which encompasses data from three prospective, randomized, parallel-group, open-label, placebo-controlled, 12-month trials conducted in the United States.
INDUSTRY BRIEFS
■ Bausch + Lomb (B+L) introduced its updated rebate website, www.BauschRebates.com, for its portfolio of lenses, offering patients and eyecare professionals a more streamlined user experience to obtain timely redemptions. The newly designed program will also make it possible for patients to use a portion of their rebate to directly support Optometry Giving Sight. The site’s launch coincides with the introduction of a mail-in rebate offer for products across B+L’s contact lens portfolio.
■ Johnson & Johnson Vision Care, Inc. announced its commitment of support to the Think About Your Eyes public awareness campaign, led by The Vision Council and the American Optometric Association. The company has committed $1.8 million in support of the program, which is designed to educate the public about eye health and promote the importance of getting an annual comprehensive eye exam.
■ Contamac recently announced the appointment of Linda Clark as company secretary. Clark has been the financial controller at Contamac for nearly 10 years. During this period, she has played an important role in the Finance Department, supporting and facilitating the company’s exponential growth. Contamac also announced that Debbie Hauk has been appointed as finance manager. Hauk is a qualified FCCA and has several years of accounting experience in manufacturing companies.
■ Visionary Optics announced the addition of Cris Garza as a clinical and field consultant. His background includes work as a consultant, contact lens fitting specializing in therapeutic and specialty fitting, and work as a clinical educator. Garza has also worked as a clinical research assistant and as an ophthalmic technician. A member of the Contact Lens Society of America and the Scleral Lens Education Society, Garza is an NCLE Advanced Certified Contact Lens Technician, an ABO Certified Optician, and a Certified Ophthalmic Technician.
■ Valeant Pharmaceuticals International, Inc. has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an intraocular-pressure-lowering single-agent eye drop for patients who have open angle glaucoma or ocular hypertension. The concerns raised by the FDA pertain to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb’s manufacturing facility in Tampa, FL where some deficiencies were identified by the FDA. The FDA’s letter did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA for latanoprostene bunod ophthalmic solution, 0.024%. Valeant intends to meet with the FDA as soon as possible to work on a resolution and address these concerns.
■ Allergan plc has exceeded its goal of donating $1 million worth of Refresh eye drops to first responders in the United States. Last summer, Allergan kicked off the Refresh America campaign aiming to help everyday heroes alleviate their discomfort from dry eye symptoms brought on by exposure to heat, wind, smoke, and dust, which are inherent to their work. Every purchase of specially marked packages in the Refresh Optive product line since August 2015 has led to more than 80,000 donations of Refresh eye drops to first responder groups nationwide. Allergan recently announced that it would extend the program through the end of 2017.
■ Optometry Giving Sight has launched its 10th Annual fundraising campaign to help raise funds for people who are needlessly blind or vision impaired simply because they can’t access an eye exam and vision care provided by an optometrist. This year’s World Sight Day Challenge will focus on the need for effective, sustainable eye health initiatives for children and adolescents. The campaign will run from Sept. 1 until Oct. 31. World Sight Day is Thursday Oct. 13. For the past 10 years, thousands of optometrists, their staff, patients, students, and colleagues in industry have taken the World Sight Day Challenge by making a tax-deductible donation and/or by raising funds to help eliminate uncorrected refractive error.
■ AllAboutVision.com, a leading source of patient education about eye health and vision correction on the Web, has been acquired by Essilor of America, Inc. AllAboutVision.com will continue to operate as an independent entity in a newly formed, California-based company wholly owned by Essilor. The website’s entire team remains in place, and its business model is unchanged. AllAboutVision.com will continue to serve a diverse, competitive set of advertisers, including Essilor. Existing advertising contracts remain in place, and the site will continue to seek new advertisers in all relevant product categories. Now in its 17th year of publishing, AllAboutVision.com has averaged more than 1 million unique visitors per week in 2016, measured weekly by Google Analytics.
■ Registration has opened for Vision Expo West 2016 in September at the Sands Expo & Convention Center in Las Vegas (Education: Sept. 14 to 17; Exhibition: Sept. 15 to 17). Registration for education courses is also open. Attendees who register by Thursday, Aug. 18 will benefit from early bird pricing: a $25 discount on registration fees. Customizable education packages are available with a la carte options, and total office pricing offers discounts for practice groups. To learn more or to register, visit VisionExpoWest.com.
■ Blanchard Contact Lenses has been named one of the top 19 leading vision care vendors in the world, according to Technavio’s global vision care market 2016-2020 report. Vendors were identified based on their revenue and market dominance in terms of experience, research & development, product portfolio, financials, and geographical presence.
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