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Up Front | Jul 2015



Alcon Receives European Approval for Preloaded IOL Delivery System



Alcon received the CE Mark for its AcrySof IQ Aspheric IOL with the UltraSert Pre-loaded Delivery System for patients undergoing cataract surgery, according to a company news release.

The delivery system combines the control of a manually loaded device with the safety and convenience of a disposable, preloaded injector to optimize implantation of the AcrySof IQ Aspheric IOL, the news release said. This approval follows the recent CE Mark for Alcon’s trifocal presbyopia-correcting AcrySof IOL, received in June.

Features of the UltraSert Pre-loaded Delivery System include the TensionGlide Plunger, a spring-controlled mechanism designed for a smooth, controlled delivery of the AcrySof IQ IOL into the capsular bag, and a plunger tip designed to support consistent IOL folding and precise placement of the IOL into the capsular bag.

The design of the UltraSert Pre-loaded Delivery System also facilitates use of a less invasive corneal incision during cataract surgery, the news release said. The smaller nozzle tip allows a corneal incision as small as
2.2 mm for insertion of the IOL, and the depth guard nozzle feature prevents the device from being inserted deeper into the incision than necessary, preserving the size of the original corneal incision.

Rayner Surgical Group Acquires OVD Portfolio

Rayner Surgical Group acquired the ophthalmic cataract surgery business of Aptissen, a company news release said.

In addition to assets in Aptissen’s research and development portfolio, Rayner acquired the following OVD products: Ophteis+ 1.4% (highly cohesive sodium hyaluronate); Ophteis 1.0% (cohesive sodium hyaluronate); OphteisMax 2.5% (viscoadaptive sodium hyaluronate); OphteisBio 1.6% (cohesodispersive sodium hyaluronate); OphteisBio 1.8% (cohesodispersive+ sodium hyaluronate); OphteisBio 3.0% (dispersive sodium hyaluronate); and Methylvisc 2.0% (hydroxypropylmethylcellulose).

“The Ophteis range offers a full spectrum of OVDs from dispersive to cohesive, which means I can select the OVD best suited to my specific cataract procedure,” Michael Amon, MD, of the Hospital of St. John, Vienna, Austria, said in the news release. “I was particularly impressed by the fact that I could store all Ophteis OVDs at room temperature and know that I will still have a reliable and consistent substance. Eliminating the need for refrigeration means one less thing for my OR staff to worry about.”

Allergan Acquires Oculeve

Allergan and Oculeve have entered into an agreement under which Allergan will acquire Oculeve in an all-cash transaction, according to a company news release. Under the terms of the agreement, Allergan will acquire Oculeve for a US$125 million up-front payment and commercialization milestone payments related to Oculeve’s lead development program, OD-01.

OD-01 is a noninvasive nasal neurostimulation device that increases tear production in patients with dry eye disease (DED). Oculeve has completed four clinical studies of OD-01 including more than 200 patients. Allergan plans to conduct two additional pivotal trials prior to FDA submission, which is expected in 2016, the news release said.

Pending approvals, Allergan anticipates closing the transaction in the third quarter of 2015.

Novartis Launches Smart Watch App Feature for Visually Impaired

Novartis released new features for its ViaOpta applications and an extension for use with smart watches, according to a company news release. The hands-free nature of using the ViaOpta app with wearable devices, such as Apple Watch and Android Wear, provides users with an experience that fits into their existing routines, allowing those with visual impairments to navigate daily life with greater ease, the news release said.

ViaOpta Nav is the first turn-by-turn navigation app available for a wearable device designed specifically for visually impaired people. The app provides voice guidance and vibration settings that alert the user to upcoming intersections and landmarks. Users can ask for their exact position, add waypoints to a calculated route, and find nearby destinations or landmarks and save them as favorites. Users and their caretakers can also share and access a person’s exact location.

ViaOpta apps are available in several languages, with additional languages currently in development, the news release said.

Ophthalmic Innovator Robert M. Sinskey, MD, dies

World-renowned cataract surgeon Robert M. Sinskey, MD, Clinical Professor of Ophthalmology at the Jules Stein Eye Institute in Los Angeles, has passed.

Among his numerous professional accomplishments, Dr. Sinskey patented his internationally popular modified J-loop IOL and invented several surgical instruments, including the widely used Sinskey hook. He also pioneered the use of low-power IOLs and the use of IOLs in infants and children with cataracts, according to his biography on the American Society of Cataract and Refractive Surgery (ASCRS) website. Dr. Sinsky served as president of ASCRS from 1999 to 2000 and was inducted into the organization’s Hall of Fame in 2005.

Born in 1924, Dr. Sinskey received his medical degree from and performed his ophthalmology residency at Duke University School of Medicine. From 1951 to 1953, Dr. Sinskey was assigned to the Atomic Bomb Casualty Commission in Hiroshima and Nagasaki, Japan, where he studied the eyes of bombing victims. In 1955, he became the first full-time instructor and opened the eye service at the University of California at Los Angeles.

Dr. Sinskey served as guest faculty and surgeon in more than 100 symposia and had more than 200 speaking engagements around the world. He published more than 30 journal articles and textbook chapters as well as a revised monograph on phacoemulsification. In addition to his teaching position at the Jules Stein Eye Institute, Dr. Sinskey served as Medical Director Emeritus of the Southern California Lions Eye Institute and was on the staff at St. John’s Health Center in Santa Monica, California.

Dr. Sinskey was a member of the ASCRS Foundation and was the driving force behind constructing and equipping the foundation’s Robert M. Sinskey Pediatric Eye Care Clinic in Addis Ababa, Ethiopia, according to his ASCRS biography.

Outside of the medical profession, Dr. Sinskey was well known for his award-winning winery, Robert Sinskey Vineyards, which sits on approximately 200 acres in Napa Valley, California.

To view EyewireTV coverage of Dr. Sinskey, visit http://eyewiretoday.com/tv/eyewiretv-mdash-ophthalmic-innovator-robert-sinskey-md-passes-away-long-term-argus-ii-results/.

Annual Global IOL Procedures to Reach 30 Million by 2020

Market Scope expects the number of global IOL procedures to climb from roughly 24.4 million procedures in 2015 to nearly 30 million procedures in 2020 at a compounded annual rate of 3.6%.1

Factors contributing to growth in the IOL market include steady growth of an aging population, the availability of enhanced monofocal and premium IOLs, robust demand for improved visual outcomes, and growing worldwide access to advanced medical technology. The fastest growth is anticipated in developing countries and regions, such as China, India, and Latin America, which have the highest population growth rates as well as relatively large population groups with cataracts that have not been surgically addressed.

Market Scope anticipates a number of enhancements to IOL designs to be made during the next 5 years. According to a news release, these are likely to include an increased number of multifocal optic designs, greater variety of toric optics, an increased number of multifocal and accommodating toric IOLs, new accommodating IOLs with greater accommodative range, IOLs with postoperative adjustability, IOLs with extended depth of focus, add-on sulcus-fixated IOLs to improve postoperative outcomes for cataract patients, and IOLs designed specifically for femtosecond laser cataract surgery. These enhancements will expand the premium IOL segment, which, by 2020, is expected to account for nearly 9.3% of total IOL procedures and almost 34% of total IOL market revenues.

According to Market Scope, the five companies dominating the global IOL market—Alcon, Abbott Medical Optics, Bausch + Lomb, Hoya, and Carl Zeiss Meditec—are expected to generate nearly three-fourths of global IOL revenues in 2015.

  1. Annual global IOL procedures are expected to reach nearly 30 million by 2020 [news release]. Market Scope. June 24, 2015. http://market-scope.com/products-page/cataract-reports/2015-comprehensive-report-on-the-global-iol-market/. Accessed July 2, 2015.

SANDE Questionnaire May Provide Quick, Reliable Measure of DED Symptoms

The Symptom Assessment iN Dry Eye (SANDE) questionnaire may provide clinicians with a short, quick, and reliable measure of DED symptoms, according to a study in Ophthalmology.1

Francisco Amparo, MD, MSc, of the Massachusetts Eye and Ear Infirmary, Boston, and colleagues conducted a study to compare patient-reported symptoms of DED as assessed by the Ocular Surface Disease Index (OSDI), a 12-item symptom-frequency–based questionnaire, and SANDE, a two-item frequency- and severity-based visual analog scale. A total of 114 patients were given the OSDI and SANDE questionnaires at baseline and follow-up visits to evaluate DED-related symptoms. Correlations between the questionnaire scores were evaluated using Spearman coefficient, and clinical differences were assessed using Bland-Altman analysis.

The investigators found that, at the baseline visit, the OSDI and SANDE questionnaire scores were significantly correlated (R=.64; P=.001). A significant correlation was also found between changes in the OSDI and SANDE scores from baseline to follow-up visits (R=.47; P=.001). After score normalization, a Bland-Altman analysis revealed a difference (bias) of less than 2 centesimal units between the scores of the two questionnaires.

“Data collected from the SANDE questionnaire showed a significant correlation and negligible score differences with those from the OSDI, suggesting that the SANDE visual analog scale-based questionnaire has the potential to provide clinicians with a short, quick, and reliable measure for DED symptoms.”

1. Amparo F, Schaumberg DA, Dana R. Comparison of two questionnaires for dry eye symptom assessment. Ophthalmology. 2015;122(7):1498-1503.

Contact Lens Wearers May Get More Infections Than Nonwearers

Using high-precision genetic tests to differentiate the thousands of bacteria that make up the human microbiome, researchers at NYU Langone Medical Center suggest that they have found a possible root cause of the increased frequency of certain eye infections among contact lens wearers.

In a report presented at the annual meeting of the American Society for Microbiology, in New Orleans, NYU Langone researchers said they have identified a diverse set of microorganisms in the eyes of daily contact lens wearers that more closely resembles the group of microorganisms of their eyelid skin than the bacterial grouping typically found in the eyes of nonwearers.1

The researchers found that the conjunctiva had surprisingly higher bacterial diversity than the skin directly beneath the eye and three times the usual proportion of Methylobacterium, Lactobacillus, Acinetobacter, and Pseudomonas bacteria in the eyes of the study’s nine contact lens wearers than was found on the ocular surface of the 11 patients in the study who did not wear contact lenses. Statistical germ diversity scores showed that the eye microbiomes of contact lens wearers had a composition more similar to that of the wearer’s skin than the eye microbiomes of nonwearers.

“Our research clearly shows that putting a foreign object, such as a contact lens, on the eye is not a neutral act,” study investigator Maria Gloria Dominguez-Bello, PhD, said in a news release. n

1. Shin H, Catalano D, Price K. Microbiota on human eyes differ between contact lens wearers and non-lens wearers. Paper presented at: American Society for Microbiology; May 31, 2015; New Orleans, Louisiana.

– Compiled by Steve Daily, Executive Editor, News;
and Callan Navitsky, Senior Editor



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Bariatric Surgery Better Than Lifestyle Changes for Improving Type 2 Diabetes
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Gene Therapy Treatment for Cystic Fibrosis May be Possible by 2020
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Discovery Could Lead to Universal Flu Vaccine
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