FDA HOLDS WORKSHOP ON MYOPIA CONTROL
On Sept. 30, the U.S. Food and Drug Administration (FDA) held a workshop to allow myopia control experts from around the world to discuss parameters for use in studies that would allow indications for contact lens and future devices for myopia control.
There was consensus that the prevalence of myopia is on the rise throughout the world, particularly in parts of Asia. The cause of the increase in myopia prevalence is unknown, but it may be related to genetics, outdoor time, near work, and a variety of other factors.
Contact lenses represent the most promising devices for myopia control, but the safety of pediatric contact lens wear is still a concern. In general, children are more compliant and have fewer complications while wearing contact lenses compared to college-aged patients, but some risks are sight-threatening. While objective measurements are important, any investigation should also include evidence of the risks and benefits perceived by subjects. A young girl participating in a myopia control study and her mother indicated that finding out answers to important clinical questions was essential, but knowing the treatment used during the investigation was important to both.
Myopia control investigations have been conducted with several devices, but study design issues still exist. A discussion of many of these issues was held between moderators, myopia control experts, FDA representatives, and audience members.
While there were small differences in opinion about children to be enrolled in a study of myopia control, the consensus was that 7- to 11-year-old children who have healthy eyes should have approximately –1.00D to –4.00D cycloplegic (tropicamide) spherical equivalent autorefraction, with less than 1.50D astigmatism and 1.50D anisometropia. It was agreed that prior progression should not affect eligibility, but subjects should not have previously used any myopia control agent.
The most appropriate control group for studies of contact lens myopia control was agreed to be single-vision soft lens wearers. The change in refractive error and axial length were both considered important primary outcomes, but axial elongation was preferred. A discussion of how to define a clinically meaningful slowing of myopia progression led to several potential definitions, including slowing by 30% to 50% over the course of the study (generally considered to be two to three years in length) or a difference of 0.75D or more during a three-year study. To measure the potential loss of treatment effect when discontinuing wear of the myopia control device at the conclusion of the study, a full year of no myopia control treatment was felt to be optimal.
A well-established definition of microbial keratitis must be used to determine myopia control device safety; an acceptable rate should be no greater than the current rates for contact lenses established in studies of adults. However, the rate cannot be established in a clinical trial, but it may be determined by combining data from trials, registries, and post-market surveillance.
Patient-reported outcomes on symptoms were thought to be important and may include parental reports of observable data. The patient-reported data could be used for the risk/benefit determination, but as an ancillary study and not as part of a clinical trial. To recruit and retain subjects, we could also learn from the subjects who drop out. To maximize recruitment, schools and recreational activity centers can be valuable resources; in addition, free eye care and products are beneficial for recruitment and retention, and social media can be used to recruit subjects at a low cost.
The need for myopia control devices is greater than it has ever been. Safe and efficacious means of slowing the progression of myopia are sought on a daily basis, and FDA clearance or approval will enable us to better educate the public about the benefits of such a treatment. This workshop was just the first step in the process, but it provided a strong review of the issues and began an important process for the FDA.
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VOLUNTARY RECALL OF PEROXICLEAR IN THE UNITED STATES AND CANADA
Bausch + Lomb (B+L) is conducting a voluntary recall, proposed Class II, of PeroxiClear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution in the United States and Canada.
Although this voluntary recall represents low risk to consumers and is unlikely to cause serious health consequences, according to B+L, the company chose to initiate this voluntary action out of an abundance of caution and as part of its ongoing commitment to quality and customer satisfaction. B+L chose to initiate this voluntary action based on internal testing that showed occasional occurrences in which the residual peroxide remaining in the lens case after neutralization was out of product specification. If the residual hydrogen peroxide is above product specification, users of the product could experience temporary symptoms of burning/stinging, irritation, red eye, and, in rare circumstances, other more serious health consequences.
The voluntary recall is limited to the United States and Canada, and PeroxiClear Hydrogen Peroxide Cleaning & Disinfecting Solution is the only product affected in this voluntary recall.
Voluntary Recalled Product Details
Product: PeroxiClear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution
Lot Numbers: All Lots
UPC Code (USA): 310119038154; 310119039106; 310119038161; 310119038178; 310119039083; 310119097120
UPC Code (Canada): 010119039211; 010119039228
FDA CLEARS LENS COATING TECHNOLOGY
Contamac Ltd. has announced the FDA clearance of Tangible Hydra-PEG (K161100), a novel contact lens coating technology that encapsulates Contamac’s Optimum GP material in an ultra-thin layer of a polyethylene glycol (PEG)-based polymer.
Tangible Science LLC (formerly Ocular Dynamics) sought to develop a technology that would reduce the ocular surface disruption caused by placing a lens on the eye. This disruption can be characterized or exacerbated by non-wetting lens surfaces, surface water evaporation, decreased tear breakup time (TBUT), deposits, and friction. According to the company, Tangible Hydra-PEG creates a surface that is highly wettable, with increased surface water retention due to the high water content (90%) of the PEG-based polymer. Additionally, Tangible Hydra-PEG creates a lubricous surface that can reduce both protein and lipid deposits as well as reduce the friction caused by the interaction between the lid and contact lens during the blink, according to the company. The Tangible Hydra-PEG technology will be installed in Optimum GP authorized laboratories throughout the remainder of 2016, with a nationwide launch planned for January 2017.
IFSLR ANNOUNCES PROGRAM DETAILS
The International Forum for Scleral Lens Research (IFSLR), scheduled for Monday, Dec. 5, 2016, has announced its program. The IFSLR will follow the 33rd Annual Cornea, Contact Lens & Contemporary Vision Care Symposium at The Westin Houston Hotel, Memorial City. It is the first scientific meeting in the world dedicated to scleral GP lenses.
The IFSLR is organized to discuss seven focus areas—midday fogging, scleral lens design, scleral topography, optical innovations, corneal oxygenation, conjunctival prolapse, and care product challenges—during which a keynote speaker outlines a problem and the research designed to solve the problem, followed by short statements by acknowledged experts. Subsequently, approximately half of the time will be devoted to an open, moderated discussion on each focus segment.
The IFSLR Scientific Executive Committee consists of Chair Jan Bergmanson, Melissa Barnett, Thomas Arnold, Ralph Stone, William Miller, Jan Svochak, and John Hibbs. It is supported by the University of Houston College of Optometry educational meeting administration led by Marcus Piccolo, Jennifer Ebert, and Amanda Johnson. Other participants include Ray Applegate, Joseph Barr, Greg DeNaeyer, Jason Jedlicka, Lynette Johns, Langis Michaud, Clarke Newman, Muriel Schornack, and Maria Walker.
This meeting is sponsored by Bausch + Lomb, Contamac, Essilor, Metro Optics, Art Optical Contact Lens, TruForm Optics, and ABB Optical Group. To register and view the complete program, visit https://ce.opt.uh.edu/live/2016/international-forum-for-scleral-lens-research.
ABB OPTICAL ACQUIRES DIVERSIFIED OPHTHALMICS, REDESIGNS SITE
ABB Optical Group, a leading distributor of optical products, has agreed to acquire Diversified Ophthalmics, Inc. and partner company MidSouth Premier Ophthalmics. Financials were not disclosed.
The merger will allow ABB Optical Group to enhance its ability to provide best-in-class service to customers. Combining the complementary geographic operations of Diversified and MidSouth in the central United States with the strong logistics network that ABB Optical already has along the East and West coasts, ABB Optical says the merger represents a good fit of business models as both organizations currently operate across four major core businesses:
• distribution of a full range of soft contact lenses;
• manufacturing and distribution of ophthalmic lenses and eyewear;
• GP and custom soft manufacturing; and
• support of practice management and buying groups (ABB Optical’s Primary Eyecare Network and Diversified’s ECP Network).
In addition to its corporate headquarters and distribution center in Florida, ABB Optical Group also has a distribution facility in Marshfield, MA; a distribution facility and its Digital Eye Lab (DEL) in Hawthorne, NY; and a distribution facility and manufacturing labs for GP and custom soft lenses, as well as its Primary Eyecare Network (PEN), in Alameda, CA.
Diversified Ophthalmics, Inc. is a total resource network for eyecare professionals. It was founded in Cincinnati in 1977 and has offices and labs in Spokane, WA; Columbia, SC; Milwaukee; and Houston. Mid-South Premier Ophthalmics got its start in 1976; with primary facilities in Nashville, Memphis, and Atlanta, it manages multiple labs and distribution facilities across the south.
Customers of ABB Optical Group, Diversified Ophthalmics, and MidSouth Premier Ophthalmics will experience business as usual. ABB Optical Group has committed to further invest in facilities, inventory, technology, and people to enhance overall customer experience and range of offerings.
In other ABB Optical news, the company has unveiled a new website designed to enhance the online customer experience. The ABBOptical.com website provides a single sign-on feature that automatically directs customers to the appropriate ordering platform based on their login information. Customers also can now access contact lens ordering, ophthalmic, GP, and specialty information all on one website.
ABB Optical says that in addition to a clean, streamlined design; a content-rich site experience; and easy-to-navigate functionality, ABBOptical.com offers access to Digital Eye Lab, a division of ABB Optical Group. Customers can get an inside look at the state-of-the-art lab, where the latest advancement in lens technology is used to create customized eyewear. Other features of the refreshed design include access to educational videos and tools such as Retail Price Monitor and patient retention resources.
CLMA ANNUAL MEETING TO BE HELD AT GSLS
The Global Specialty Lens Symposium (GSLS) is pleased to announce the co-location of the Contact Lens Manufacturers Association (CLMA) annual meeting during the Jan. 26 to 29, 2017 GSLS at the Las Vegas Rio Hotel.
GSLS Education Chairman Craig W. Norman stated that CLMA members have played an integral role in supporting the GSLS over the past 11 years and that the GSLS Exhibit Hall is the perfect place for contact lens manufacturers to demonstrate their products and services to a focused audience of contact lens specialists and educators from more than 30 countries every year.
He also stated that because many CLMA members are already at the GSLS, it makes sense for the CLMA to co-locate its meeting at the same site.
CLMA Annual Meeting Chairman Keith Parker noted that the CLMA is especially excited about the 2017 event, during which attendees will have several opportunities in the GSLS exhibit hall to watch the live fabrication of scleral, corneal, multifocal, and toric GP lenses from start to finish. For any practitioners who have not been able to see this process with their respective CLMA labs, this is a great opportunity to see how specialty GP lenses are manufactured.
• Sensimed AG has announced the expansion of its current collaboration with SEED, a Japanese contact lens manufacturer. The agreement enables the companies to combine efforts to work to obtain registration of the Sensimed Triggerfish, which provides an automated recording of continuous ocular dimensional changes over 24 hours. Following approval and agreement with PMDA, the companies will then work to conduct key pivotal clinical activities in Japan. Sensimed is also now seeking a strategic partner in the United States to execute a planned prospective study focused on predicting fast versus slow progressive glaucoma in a representative patient population. Once validated, the company says this will provide a valuable benefit to practitioners to better manage glaucoma patients.
• CooperVision has unveiled PrescribeOxygen.com, a new website that provides eyecare professionals with details about the benefits of contact lenses with high oxygen transmissibility. The company says that PrescribeOxygen.com will help educate eyecare professionals not only about CooperVision’s portfolio of silicone hydrogel daily disposable lenses, but also will provide the data that supports prescribing patients a healthier one-day lens.
• The American Optometric Foundation (AOF), in collaboration with Beta Sigma Kappa International Honor Society, is pleased to announce Anna F. Ablamowicz, OD, FAAO, clinical assistant professor at the University of Alabama at Birmingham School of Optometry, as the 2016 recipient of the Beta Sigma Kappa (BSK) Research Fellowship. The fellowship is designed to provide support for early career optometric and vision science faculty research that will fund Dr. Ablamowicz’s project, “Investigation of an Inflammatory Component of Lid Wiper Epitheliopathy in Dry Eye Disease.”
• Katena Products, a provider of precision ophthalmic instruments, biologics, and devices to hospitals, surgical centers, and ophthalmic and optometric offices, has purchased Eagle Vision, a market leader in the punctal plug product category. These plugs, along with other ancillary devices, are primarily used in the treatment of dry eye syndrome.
• RevolutionEHR, a provider of cloud-based practice management and electronic health record (EHR) software for eye care, is pleased to announce the acquisition of Getwell, a provider of cloud-based EHR and PMS software to eyecare practices. The acquisition, completed in June 2016, provides users of Getwell, Visions, and Eyebase software a seamless and supported transition for implementing RevolutionEHR in their practices. James Diecidue, founder of Getwell, and Dr. Anthony Diecidue, founder of Visions and Eyebase, join the RevolutionEHR team.
• Novaliq GmbH appointed Christian Roesky, PhD, as the company’s CEO, effective Nov. 1, 2016. Dr. Roesky will lead Novaliq as it develops and brings to market innovative therapeutics for a broad range of ophthalmic indications, including dry eye, glaucoma, and retina diseases. Previously, Dr. Roesky was general manager of Bausch + Lomb GmbH / Dr. Mann GmbH in Berlin; managing director of the Diagnostics Division, and general manager and speaker of the Country Management Board of Abbott GmbH & Co. KG in Wiesbaden; and general manager of Alcon German & Austria (Novartis). Bernhard Günther, formerly Novaliq’s CEO, will take on the new role of chief innovation officer.
• SECO International is currently accepting nominations for its 2017 awards program, which recognizes significant contributions to the profession of optometry. SECO will present Optometrist of the South, SECO’s highest honor; Young Optometrist of the South; and Paraoptometric of the South awards at its 94th Annual Congress during the Southern Council of Optometrists (SoCO) House of Delegates meeting at the Georgia World Congress Center in Atlanta on Mar. 4, 2017. Nominations should include a letter with the nominee’s name, the name of the award for which the nominee is being submitted, the city and state of the nominee’s practice, the reasons why the nominee should receive the award; and a copy of the nominee’s biography or curriculum vitae. Nominations must be received no later than Nov. 30, 2016. For more information about the Congress and awards program, visit www.secointernational.com.
• CooperVision, Inc. has renewed its commitment as a Global Gold Sponsor of Optometry Giving Sight for another three years, effective January 2017. CooperVision’s cumulative support for vision care projects that are helping to eliminate uncorrected refractive error is expected to exceed $2 million by the end of 2016.
FDA CLEARS CONTACT LENS FOR TREATING CORNEAL EDEMA
The U.S. Food and Drug Administration recently cleared an Israeli-developed contact lens used to treat corneal edema, a painful eye condition commonly caused by eye surgery, trauma, or aging. The edema (swelling) causes the cornea to lose its transparency, affecting vision and leading to irreversible scarring of the cornea.
Israeli startup EyeYon Medical’s disposable contact lens, Hyper CL, relieves pain by extracting fluids via osmosis and smoothing the surface of the cornea, thus improving vision and keeping the surface of the eye covered to protect from infection.
EyeYon Medical says that before Hyper CL, there was no effective way to relieve symptoms of the condition, which can be cured only with a donor cornea.
In the United States, about 12% of the 3.5 million cataract surgeries every year result in temporary corneal edema, and 1% of those cases become chronic. Corneal edema can also be caused by trauma, aging, infection, corneal disease, or a genetic defect known as Fuchs’ Dystrophy.
EyeYon plans to market its lenses in the United States beginning in 2017.
NATIONAL VISION INC. ANNOUNCES 2016-2017 GRANT PROGRAM
Through its 2016-2017 Grant Program, National Vision Inc. is urging students to tackle the topic of technology innovation. Third- and fourth-year optometry students from across the United States are eligible to apply for the chance to win a $5,000 grand prize.
To enter, applicants must write a 500-word essay or create a short video sharing their perspectives on the impact of technology on the field of optometry in the past and how it will influence their future careers as optometrists. Additional information and entry requirement details can be found on the Optometry Students section of www.nationalvision.com.
All submissions and questions regarding the program should be sent to Carly.Schenck@nationalvision.com by Jan. 31, 2017.
FIRST FDA-APPROVED CROSS-LINKING PROCEDURES PERFORMED IN THE U.S.
Avedro, Inc. is now shipping Photrexa Viscous and Photrexa, the drugs used in corneal cross-linking (CXL) procedures with the KXL System. On April 15, Avedro received approval from the U.S. Food and Drug Administration (FDA) for Photrexa Viscous, Photrexa, and the KXL System used in CXL for the treatment of progressive keratoconus. Subsequently, on July 15, the company received FDA approval for the treatment of corneal ectasia following refractive surgery.
VOLK EYE CHECK NOW INCORPORATES B+L LENSES
Volk Optical has integrated Bausch + Lomb Specialty Vision Products custom specialty lens designs into the Best Fit Analysis Report of its Volk Eye Check portable ophthalmic exam tool.
Capable of a number of key measurements, the Volk Eye Check’s CL Mode captures and fully automates the analysis and display of ocular characteristics for contact lens fitting, saving time and increasing first time fit rates, according to the company.
Volk Optical says its Volk Eye Check’s CL Mode provides precise measurements to aid in contact lens fitting, including horizontal visible iris diameter (HVID), pupil diameter and sagittal depth. The Best Fit Analysis feature generates a patient-specific report recommending the most appropriate contact lenses by brand and type.
Now included in the Volk Eye Check Best Fit Analysis module are fitting rules for Bausch + Lomb Specialty Vision Products’ HP Toric and Sphere; Astera Multifocal Toric; NovaKone; and C-Vue Toric, Sphere, and Multifocal design contact lenses.
All current Volk Eye Check users will automatically have access to the Bausch + Lomb Specialty Vision Products designs.
For more information on the Volk Eye Check’s Best Fit Analysis Report, and to request a free trial, visit www.volk.com or call Volk at (800) 345-8655.