NEWSspectrum
New Data Available on Treatment for Dry Eye
Shire Plc recently announced positive topline results from OPUS-3, a phase 3 efficacy and safety study of lifitegrast, an experimental ophthalmic solution for signs and symptoms of dry eye disease in adults, versus placebo. These data showed that OPUS-3 met the primary endpoint of significantly improving patient-reported symptoms of dry eye disease from baseline to day 84 (p=0.0007). Additionally, OPUS-3 met the secondary endpoints of symptom improvement from baseline to days 14 and 42 (p<0.0001 for both endpoints).
The OPUS-3 study results came on the heels of an announcement by Shire in mid-October that the U.S. Food and Drug Administration had declined to approve lifitegrast for the present time. In a complete response letter, the FDA requested an additional clinical study and further information related to product quality.
Lifitegrast binds to the integrin lymphocyte function-associated antigen-1 (LFA-1), a cell surface protein found on leukocytes, and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1). ICAM-1 is overexpressed in corneal and conjunctival tissues in dry eye disease.
Lifitegrast was originally granted priority review status by the FDA in April 2015. Shire plans to use these new data as part of the resubmission of the New Drug Application (NDA) for lifitegrast for the treatment of signs and symptoms for dry eye disease in the first quarter of 2016. Further, Shire plans to use these data, in conjunction with the existing comprehensive clinical data set, for regulatory filings for lifitegrast in other markets outside of the United States.
BHVI Provides New Grading Scales for Free to Practitioners
Brien Holden Vision Institute has released new Grading Scales that provide eyecare practitioners with an easy-to-use consulting room guide for monitoring common contact lens complications, according to the organization. The Grading Scales can be downloaded for free from BHVI’s Academy website (academy.brienholdenvision.org).
The Grading Scales can be used as an in-practice reference tool that BHVI says provides a guide for determining the severity and progression of complications—such as bulbar redness, limbal redness, and corneal staining—as well as descriptions and photographs of adverse effects associated with contact lens wear.
BHVI further states that the Grading Scales also allow eyecare practitioners to make consistent clinical management decisions.
B+L Announces New Division
With the acquisition earlier this year of Paragon Vision Sciences, combining Bausch + Lomb’s (B+L’s) Boston division with the newly acquired company, B+L is taking steps to effectively address the dramatic increase in myopia in the United States and abroad, according to a letter from the company to eyecare practitioners. The letter further states that “serious eye disease has left millions of patients in dire need of better specialty contact lens options for keratoconus, severe dry eye, post-surgical needs, and corneal transplants, which can be addressed through Gas Permeable (GP) options such as scleral lenses.”
To help address these concerns, the company has announced the launch of a newly created division, Bausch + Lomb Advanced Vision Products, which will be dedicated to addressing severe ocular conditions including myopia, irregular corneas, ocular surface diseases, and other serious visual challenges.
The company says that Bausch + Lomb Advanced Vision Products will work under this new division with the goal to further develop and grow the specialty lens segment by providing:
• Customized contact lenses, including orthokeratology and scleral lenses, and companion lens care products.
• Continued innovation across GP, customized soft lens, and lens care categories.
• Training in scleral lens and ortho-k fitting, with a variety of educational programs available via workshops, webinars, and online tools.
• Continued support for the development of state-of-the-art diagnostic fitting and dispensing systems of these advanced technology products.
• Lens care products to help ensure that patients closely follow practitioner-provided lens care regimens.
In a separate announcement, B+L stated that the company is committed to furthering the education and training programs offered to GP contact lens practitioners and their staff. The company also plans to soon launch an additional $150K grant program for educational institutions in the United States focused on the advancement of specialty contact lens understanding and education.
In other company news, B+L recently announced plans to spend $150 million and hire as many as 200 people, expanding its contact lens solution plant in Greenville, SC and related distribution center. The Greenville News reported that Greenville County officials had expected lower numbers—a capital expenditure of at least $20 million and about 30 jobs—because those were the numbers included in an incentives agreement the county negotiated with B+L.
J. Michael Pearson, chairman and CEO of Valeant Pharmaceuticals International, parent company of B+L, stated that B+L’s contact lens solutions business is growing rapidly around the world and that B+L would likely close a small contact lens solution manufacturing operation in Europe because the Greenville plant is more efficient.
Alcon to Launch Hands-on Training Facility
Alcon will soon open its new Alcon Experience Center, a state-of-the-art, hands-on training facility at the company’s corporate headquarters in Fort Worth, TX. When completed in November 2015, the company says that the Alcon Experience Center will offer eyecare practitioners, students, and residents more than 34,000 square feet of training space. It will feature a fully equipped optometric office training area with exam lanes to help simulate actual practice environments. In addition, it will facilitate training resources and knowledge transfer to help improve surgeon confidence. Alcon says that the Center will also include a variety of interactive, innovative, and flexible technologies to help create a world-class training experience. Courses are expected to start in early 2016.
New Student Grant Program
National Vision, Inc. is encouraging students to reflect on why they are interested in practicing primary care optometry and to consider the key issues affecting their future profession through a new 2015-2016 Grant Program. 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 describing their perspectives on the need for affordable, primary eye care in today’s changing healthcare environment. Visit the Student section of NVIOptometry.com for more information. Applications are due Jan. 31, 2016.
Harmful Chemicals Found in Decorative Lenses
The American Academy of Ophthalmology has issued a warning about over-the-counter decorative lenses after a recent study found that several varieties tested positive for chlorine and other harmful chemicals. The study found chlorine in three types of non-prescription costume contact lenses, and iron was found on four pairs of lenses. The chemicals may come from colorants used to tint and create patterns on the lenses. One pair seeped chlorine after a routine rinse, prompting concern from researchers about toxicity to the eye. The study also noted that colorants printed or pressed onto some decorative lenses created an uneven texture, which could scratch the eyes, potentially allowing in bacteria that could cause infection or blindness. Four of the five lenses tested are not approved by the U.S. Food and Drug Administration for sale in the United States.
Enrollment Begins for Topical Presbyopia Treatment Study
Encore Vision, Inc., a privately held ophthalmic pharmaceutical company, recently announced that the U.S. Food and Drug Administration (FDA) has granted Encore’s Investigational New Drug (IND) application as safe to proceed with the clinical development of EV06 topical ophthalmic solution to treat presbyopia. The company has since enrolled the first subject into its Phase 1 & 2 trial, which it believes is the first ever clinical evaluation of a new chemical entity intended to address an underlying process that causes presbyopia.
EV06 (Lipoic Acid Choline Ester, 1.5%) is a first-in-class new chemical entity that targets a biochemical cause of presbyopia, believed to be associated with an increase in the formation of disulfide bonds between the crystalline proteins within lens fiber cells. EV06 is intended to increase lens flexibility by breaking these bonds, thereby restoring elasticity, allowing the lens to focus on nearby objects. EV06 is a prodrug that penetrates the cornea and is subsequently broken down into lipoic acid and choline, two naturally occurring substances. Administration of EV06 may potentially halt or reverse the stiffening that occurs, allowing the lens to maintain or regain its ability to accommodate.
The Phase 1 & 2 prospective, randomized, double-masked, multicenter study will compare the safety and efficacy of EV06 to placebo in subjects 45 to 55 years of age who have presbyopia. The 90-day study will aim to enroll 72 subjects and evaluate mean change in distance-corrected near visual acuity (DCNVA) and best-corrected distance visual acuity (BCDVA) along with additional secondary outcomes.
Taddeo Joins Alden Optical
Alden Optical has announced that Andy Taddeo, FCLSA, NCLE-ADV, has joined the company as a product specialist. His primary responsibility will be to consult with practitioners on complex specialty fitting toward successful outcomes with Alden designs. Mr. Taddeo has more than 30 years of hands-on specialty fitting experience in several central New York practices.
New Euclid Ortho-k International Certification Program
Euclid Systems Corporation, maker of the Emerald orthokeratology (ortho-k) lens, recently announced the Euclid Orthokeratology International Certification (EOIC) program, an ortho-k education and training program that the company states is intended to yield a significantly higher level of expertise among eyecare practitioners throughout China. This program is a collaboration among Euclid, the Illinois College of Optometry, and Tianjin Medical University. Qualified eyecare practitioners will have the opportunity to participate in a five-day, hands-on training program that will include 25 hours of lectures and wet labs for fitting of actual patients.
EOIC launched on Oct. 26, 2015 in Tianjin.
B+L to Acquire Ocular Allergy Diagnostic Startup
Bausch + Lomb (B+L), a division of Valeant Pharmaceuticals International, will acquire ophthalmic diagnostic startup Doctor’s Allergy Formula for an undisclosed amount. Doctor’s Allergy Formula will be integrated under the company’s pharmaceuticals division. B+L will gain an FDA-approved test to diagnose and identify the cause of ocular allergies—with the expectation that the test is becoming the standard of care.
The startup was founded in 2013 by ophthalmologist Dr. Howard Loff. Its Ocular Allergy Diagnostic System is already used by at least 1,250 ophthalmologists. The ocular allergy test is noninvasive and doesn’t involve needles, and it is designed to be used in-office at the point of care. It requires three minutes to administer, with results available in about 15 minutes, and uses a panel of 60 regionally specific allergens. The Doctor’s Allergy Formula test, which is typically covered by major medical insurances, helps to distinguish ocular surface disease (OSD) pathology such as dry eyes, ocular allergies, and blepharitis, as routinely these signs and symptoms of OSD can be similar.
Dailies Total1 Now in Plus Powers
Alcon, a division of Novartis, has extended its line of Dailies Total1 water gradient contact lenses to include plus power lenses for hyperopic patients. The plus power lenses will be available in the United States in November 2015. Dailies Total1 lenses were designed to mimic the environment of the cornea with water content of almost 100% at the outermost surface.
The lenses are available with a power range of –0.50D to –6.00D (in 0.25D steps); –6.50D to –10.00D (in 0.50D steps), and soon in plus powers from +0.50D to +6.00D (in 0.25D steps).
Bennett Wins Michael G. Harris Award
At the American Academy of Optometry meeting last month in New Orleans, Edward S. Bennett, OD, MSEd, FAAO, FSLS, was awarded the Michael G. Harris Award for Excellence in Optometric Education. This award is presented by the American Optometric Foundation to an optometric educator who has demonstrated ongoing and consistent excellence in the education of optometry students and/or the advancement of optometric education. Each candidate is judged by his or her contribution and excellence in optometric education by virtue of performance in any or all of the following areas: teaching (classroom, laboratory, clinic, distance learning), scholarship that enhances optometric education, and organizational work that enhances optometric education. Dr. Bennett is assistant dean for Student Services and Alumni Relations at the University of Missouri-St. Louis College of Optometry, executive director of the GP Lens Institute, and clinical features editor of Contact Lens Spectrum.
INDUSTRY BRIEFS
■ Johnson & Johnson Vision Care, Inc. now offers the Acuvue Oasys 1-Week for Overnight Use Annual Supply pack, which is a 54-count box of Acuvue Oasys lenses intended for patients to wear continuously for a week and then discard. The two additional lenses are intended as replacements in the event that lenses are lost or damaged. The pack is designed to offer convenience for patients who choose to wear their lenses on an extended wear basis and to help encourage regular weekly replacement.
■ Contamac, Ltd. has appointed John Hibbs as national accounts manager, Vision Care North America. He has 30 years of experience in the contact lens industry and has gained an excellent reputation in the specialty contact lens industry for supporting and engaging in his customers’ long-term growth strategies, according to Contamac.
■ Valley Contax Inc. has recently changed ownership. Founder Stephen G. Young made his final step toward retirement in early September, selling the company to his two longest-serving employees, company President Janice Adams and Vice President Josh Adams. With a combined 58 years of experience (Janice and Josh) in their optical careers, Valley Contax is one of the industry’s leading independent custom contact lens manufacturers. Both Janice and Josh have served on the CLMA Board of Directors, and Janice led the CLMA as president from 2006 through 2008. To find out more about Valley Contax, visit www.valleycontax.com.
■ NovaBay recently provided an update on its Intelli-Case for hydrogen peroxide contact lens disinfection. The company has combined the Intelli-Case device with two hydrogen peroxide bottles into a new consumer-packaged product called NovaClear, which is sufficient for 60 days’ use. NovaBay is set to launch a test market program in select cities in California either late this year or early in 2016. Intelli-Case monitors the neutralization of hydrogen peroxide during the disinfection cycle with microprocessor electronics embedded in the cap of what otherwise looks like a standard peroxide lens case. The LED indicators on the lid inform users of whether the lenses are safe to apply to the eyes.
■ Alden Optical has announced that its licensing partner Solótica Lentes de Contato has launched Zenlens, the company’s scleral design, into the Brazilian market. This launch is the result of an extensive evaluation and development project to manufacture Zenlens under license in Brazil. Solótica is the largest Brazilian contact lens manufacturer. In other Alden news, the company recently deployed new patient resources to address the growing demand for prosthetic and cosmetic tinted custom lenses. The resources include a revamped patient landing page at www.aldenoptical.com/patient-information/patient_information/#patientinfo that clearly describes the company’s product, strongly encourages patients to speak with eyecare practitioners, and has a new Practice Locator Map.
■ With new developments such as hybrid lenses, scleral lenses, and lenses with sophisticated designs such as quadrant-specified lenses, the need for trial lens sets has increased. On the other hand, the need for safe hygienic management causes insecurity about handling, disinfection, and storage of contact lenses used on multiple patients. Therefore, the International Organization for Standardization (ISO) is working on developing new standards for trial lens handling and usage. It is the goal to develop a safe standard without complicated procedures. The project leader is gathering information about the use of trial lenses. To participate, fill out a confidential online form at www.umfrageonline.ch/s/b14dc36.
■ Ursapharm and Novaliq have entered into a partnership agreement and have announced the initial European launch of EvoTears eye drops. As part of the agreement, Ursapharm will obtain the exclusive license for the commercialization of EvoTears, Novaliq’s first commercially available ophthalmic product for evaporative dry eye diseases. Ursapharm’s ophthalmic portfolio includes Hylo Eye Care for dry eye treatment and a broad variety of ophthalmic products in the segments of antibiotics, anti-glaucomatosa, and anti-inflammatory treatments.
■ Registration is now open for Vision by Design 2016, presented by The American Academy of Orthokeratology and Myopia Control, which will take place from April 6 to 10, 2016 in Scottsdale, AZ. Visit www.orthokmeeting.com for more information.
■ Alcon is a title sponsor of the Tear Film & Ocular Surface Society’s (TFOS) second International Dry Eye WorkShop (DEWS II). This year’s workshop is intended to update the definition, classification and diagnosis of dry eye disease, critically assess the etiology, mechanism, distribution and global impact of this disorder, and address its management and therapy. Since 2000, Alcon has partnered with TFOS to advance ocular surface research, contributing more than $1.5 million in support of research reports, summaries, publications and conferences. The first TFOS International Dry Eye WorkShop (DEWS) produced a comprehensive report published in a special 2007 issue of The Ocular Surface journal. This report was made available to TFOS members through Alcon’s support, spurring increased research in the dry eye disease area. A second report from this year’s Dry Eye Workshop (DEWS II) is expected to be published by TFOS in early 2017.
■ Prevent Blindness has declared November to be Diabetic Eye Disease Awareness Month to help educate the public on diabetes prevention strategies, potential risk factors, treatment options, and Medicare coverage policies. Prevent Blindness offers a variety of free resources dedicated to the education of diabetic eye disease, including its dedicated website, preventblindness.org/diabetes.
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