NOVARTIS TO ACQUIRE XIIDRA FROM TAKEDA
Novartis has entered into an agreement with Takeda Pharmaceutical Company Limited to acquire the assets associated with Xiidra (lifitegrast ophthalmic solution) 5% worldwide. Closing of the transaction is expected in the second half of 2019, subject to customary closing conditions including regulatory approvals. On closing, Novartis plans a smooth transition of operations and integration of Xiidra into its pharmaceuticals portfolio.
In addition to powering Novartis’ ability to serve more patients suffering from eye disease, the company says that the additional commercial experience established with Xiidra is expected to better position the company for front-of-the-eye pipeline products currently in development.
Deal terms include a $3.4 billion upfront payment with potential milestone payments of up to $1.9 billion. As part of the agreement, Novartis will be taking on approximately 400 employees associated with the product. ■
PREVENT BLINDNESS TO HOST EIGHTH ANNUAL FOCUS ON EYE HEALTH NATIONAL SUMMIT
Prevent Blindness will hold its eighth annual Focus on Eye Health National Summit on July 17, 2019 at the National Press Club in Washington, D.C. The Summit will include a variety of presentations related to this year’s theme, “A Lifetime of Vision.” Those unable to attend in person will have an opportunity to watch a live video stream of event presentations as well as to follow the event on Twitter at #eyesummit.
The keynote speaker is Bill Barkley, a visually impaired adventurer, advocate, and author. He will share tales of his accomplishments including being the first deaf-blind individual to climb Mount Kilimanjaro in Africa in 2008, leading expeditions for deaf teenagers to the Amazon jungle and the Grand Canyon, and being the first deaf-blind person to complete the Boston Marathon.
Silver sponsors include the Alliance for Eye and Vision Research (AEVR), American Academy of Ophthalmology, American Optometric Association, Association for Research in Vision & Ophthalmology, Bausch Foundation, BrightFocus Foundation, CooperVision, Foundation Fighting Blindness, Lions Clubs International, Mallinckrodt Pharmaceuticals, OneSight, Research to Prevent Blindness, Vision 2020 USA, Vision Impact Institute, and VisionServe Alliance.
To register or for more information, visit www.preventblindness.org/eyesummit . ■
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MEDICINE-RELEASING CONTACT LENS IN DEVELOPMENT
Researchers at the Fraunhofer Institute for Applied Polymer Research (IAP) are working with Israeli and German partners to develop long-wearing contact lenses that can release medicine. The Israeli partner company EyeYon Medical has already developed drug-administering contact lenses that the company says ensure longer residence times of the active substances.
The goal is to coat the inside of the lens with liposomes that carry a drug and release it over time. The liposomes are produced at the Weizmann Institute of Science by a research group led by Prof. Jacob Klein and Dr. Ronit Goldberg. However, the use of liposomes is not the only strategy for optimizing lenses. Sugars are also added to make the lens comfortable to wear, according to the company. Surflay Nanotec is developing the glycopolymer coating on the contact lens.
The five partners and two subcontractors (DendroPharm GmbH and Nextar Chempharma Solutions) are working to obtain an approved medical device. The three-year project will run until July 2021. The researchers must also ensure that all of the components are biocompatible. Biocompatibility tests are being carried out at the Rostock University Medical Center. The subcontractors are also checking whether all system components have been manufactured in accordance with good manufacturing practice guidelines.
The project is receiving around 1 million euros in funding from the German Federal Ministry of Education and Research. ■
FTC SEEKS ADDITIONAL PUBLIC COMMENT ON PROPOSED CHANGES TO THE CONTACT LENS RULE
The Federal Trade Commission (FTC) announced that it is seeking additional public comment about newly proposed changes to the agency’s Contact Lens Rule. The new proposal follows an extensive review and consideration of thousands of public comments and material received by the Commission between 2015 and 2018, including surveys, studies, analyses, and information generated at an FTC workshop devoted to the Rule and the evolving contact lens marketplace.
The FTC is now seeking comment on modifications to its earlier proposal to enhance compliance with the Fairness to Contact Lens Consumers Act’s requirement that prescribers automatically provide their patients with a copy of their prescription upon completion of a contact lens fitting.
The FTC believes that the newly developed modifications will achieve the goals of its original proposal while imposing less of a burden on prescribers. Highlights of the supplemental notice include:
- requesting that patients acknowledge receipt of the contact lens prescription by signing a separate confirmation statement;
- requesting that patients sign a prescriber-retained copy of the prescription that contains a statement confirming that patients have received it;
- requesting that patients sign a prescriber-retained copy of the sales receipt for the examination that contains a statement confirming that patients received the prescription; or
- providing patients with a digital copy of the prescription and retaining evidence that it was sent, received, or made accessible, downloadable, and printable.
Complete information is detailed in the soon-to-be-published Supplemental Notice of Proposed Rulemaking, which can be found at www.ftc.gov/policy/federal-register-notices/16-cfr-part-315-contact-lens-rule-supplemental-notice-proposed . ■
CONTACT LENS WITH A FLEXIBLE MICRO-BATTERY UNDER DEVELOPMENT
The Optics Department at IMT Atlantique, headed by Professor Jean-Louis de Bougrenet de la Tocnaye, and the Flexible Electronics Department at the Centre Microélectronique de Provence Georges Charpak (Mines Saint Etienne), headed by Professor Thierry Djenizian, are currently working together to design an oculometer embedded in a scleral contact lens. They have recently created an autonomous contact lens incorporating a flexible micro-battery.
A partnership with contact lens manufacturer LCS has enabled the first elements of this new type of intelligent contact lens to be encapsulated (the LED can be easily integrated into the contact lens if necessary).
The battery integrated within the lens will complement and power other functions being developed at IMT Atlantique, such as radio frequency (RF) communication (wireless function) and, particularly, optical detection of gaze direction. This project will involve numerous collaborations, including one with the Institut de la Vision in Paris for a visual assistance device for the blind. ■
MARYLAND EXPANDS SCOPE OF PRACTICE FOR OPTOMETRISTS
Maryland Gov. Larry Hogan has signed into law a measure expanding optometrists’ scope of practice.
Signed into law April 30, the bipartisan legislation (House Bill 471/Senate Bill 447) amends the state’s optometric scope of practice to repeal certain provisions of law that required a therapeutically certified optometrist to refer certain patients to an ophthalmologist. It also authorizes prescribing authority for topical agents and oral pharmaceuticals (with some exceptions) for the prevention, management, or treatment of conditions and diseases of the eye and ocular adnexa and expands procedures and management of certain patients.
The measure will take effect in March 2020. ■
GSLS 2020 SPOTLIGHT: NEW WORKSHOPS
The Global Specialty Lens Symposium (GSLS) Program Committee announced two new workshops that will debut at GSLS 2020 (Jan. 22 to 25, 2020 in Las Vegas).
The two workshops—one on scleral contact lenses and the other on dry eye and ocular surface disease—will take place on Jan. 22, 2020 from 6:00pm to 8:00pm. Attendees are also invited to attend a wine and hors d’oeuvre reception prior to the workshops.
To learn more about these workshops and all that will be offered at GSLS 2020, visit www.gslsymposium.com . ■
AAOF ANNOUNCES THE 2019 WILLIAM C. EZELL FELLOWSHIP RECIPIENTS
The American Academy of Optometry Foundation (AAOF) announced the 13 recipients of the 2019 William C. Ezell Fellowships. The Ezell Fellowship program is named after the founding president of the AAOF, William C. Ezell, OD. It was established to provide recognition and support to talented post-doctoral students who are pursuing an advanced degree in optometric research and education.
- AAO Section on Cornea, Contact Lenses and Refractive Technologies Ezell Fellow
—Kelsy R. Steele, OD, MS, The Ohio State University College of Optometry - American Academy of Optometry Foundation Robert Mandell Ezell Club Fellow
—Heinz Otchere, OD, MS, University of Waterloo School of Optometry and Vision Science - American Academy of Optometry Ezell Fellow
—Billie Beckwith-Cohen, DVM, MBA, University of California Berkeley School of Optometry - Baycross Christian Family Foundation Binocular Vision & Pediatrics Ezell Fellow
—Maureen D. Plaumann, OD, The Ohio State University College of Optometry - Danne Ventura – Essilor Ezell Fellow
—Eugene Appenteng Osae, OD, University of Houston College of Optometry - Irvin M. Borish – Essilor Ezell Fellow
—Hin Cheung, OD, Indiana University School of Optometry - John N. Schoen Ezell Fellow
—Reza Abbas Farishta, BSc, MSc, OD, University of Montreal School of Optometry - Merton C. Flom Leadership Ezell Fellow
—Jessica V. Jasien, MEn, University of Alabama at Birmingham School of Optometry - Mike Daley – Essilor Ezell Fellow
—Revathy Mani, BSOptom, MPhil, University of New South Wales School of Optometry and Vision Science - Michael G. Harris – Ezell Fellow
—Rajendra Gyawali, BOptom, MOptom, University of New South Wales School of Optometry and Vision Science - Optometric Glaucoma Society Ezell Fellow
—Laura Pardon, OD, MS, University of Houston College of Optometry - Rod Tahran – Essilor Ezell Fellow
—Gareth D. Hastings, MPhil, BOptom, University of Houston College of Optometry - Vision Impact Institute Ezell Fellow
—Afua Asare, OD, MPH, MSc, University of Toronto ■
OPTOMETRY STUDENT CHALLENGE ANNOUNCED
ABB Optical Group, in partnership with Paragon Vision Sciences, announced that it is accepting abstract submissions for the fifth annual Optometry Student Challenge.
The Optometry Student Challenge will award travel grants of $1,500 each to three third- or fourth-year students to attend the 2020 Global Specialty Lens Symposium, held on Jan. 22 to 25, 2020 in Las Vegas, and present a scientific poster on a topic related to contact lenses. Last year, more than 90 optometry students submitted contact lens-related abstracts focused on study projects or student-based case histories.
Students who are interested in participating must register by Aug. 9, 2019. Registered students must then submit an abstract on their proposed poster topic by Oct. 11, 2019. Abstracts must focus on study projects or student-based case histories related to contact lenses. Abstracts will be judged in two categories: case study report and research.
Five finalists will be selected and notified by Oct. 25, 2019. The finalists will then be required to convert their abstracts into scientific posters for further judging. The posters must be submitted in digital, PDF format to ABB Optical Group no later than Nov. 15, 2019. Results will be communicated with the winners and runners-up by Nov. 27, 2019.
For more information on the Optometry Student Challenge, including full contest rules and guidelines, visit ABBOptical.com/OptometryStudentChallenge . ■
INDUSTRY BRIEFS
- Last month, 1,000 U.S.-based Contact Lens Spectrum readers were sent the annual International Survey of Contact Lens Prescribing. Please check your mailboxes and inboxes to see whether you were one of the lucky few chosen to participate in this important research. Data collected from U.S. prescribers as well as data collected from more than 30 other global contact lens markets are tabulated and analyzed by Eurolens Research to create a snapshot of current international lens prescribing trends. Your participation in this survey is vital to create an accurate picture of current U.S. prescribing trends. If you received the survey but do not fit contact lenses, please pass it on to a colleague who does. Survey forms must be returned by Aug. 15, 2019. Results will publish in the January 2020 CLS article “International Contact Lens Prescribing in 2019.”
- Hardy Capital, a Canadian investment firm, has completed the acquisition of LD Vision Group. LD Vision Group is an independent direct retailer in eye care; its brands include OptiContacts.com and ContactsExpress.ca . Roger Hardy, CEO of Hardy Capital, previously founded Coastal.com , owner of Clearly.ca and Lensway.se , that was acquired by Essilor in 2014. Mr. Hardy is joined by Sabrina Liak, who was previously with Goldman Sachs Investment Partners, and Joseph Thompson, who was previously with Amazon and Procter & Gamble. The purchase of LD Vision Group marks the second investment in the eyecare category by the Hardy Capital team. In 2018, the team made a seed-stage investment in the millennial hypergrowth brand, Privé Revaux. Canaccord Genuity Petsky Prunier served as the exclusive financial advisor to LD Vision Group in this transaction.
- Bausch + Lomb announced the appointment of new leadership in its Pharmaceuticals and Consumer Health Care divisions in the United States. Yolande Barnard, formerly the vice president, marketing and sales, U.S. Neurology, Bausch Health, will now serve as vice president and general manager, U.S. Pharmaceuticals, Bausch + Lomb. Chris Marschall, most recently vice president, marketing for Bausch + Lomb’s U.S. Consumer Health Care business, has been promoted to vice president and general manager, U.S. Consumer Health Care. Ms. Barnard and Mr. Marschall assume responsibility for the day-to-day management of their respective businesses, ensuring all marketing and sales goals and objectives are met while increasing operating performance. Ms. Barnard and Mr. Marschall will join John Ferris, vice president and general manager, U.S. Vision Care, and Chuck Hess, vice president and general manager, U.S. Surgical, to round out Bausch + Lomb’s fully integrated eye health leadership team in the United States. Ms. Barnard and Mr. Marschall are based at the company’s headquarters in Bridgewater, NJ.
- Akorn announced that it received a new abbreviated new drug application approval from the U.S. Food and Drug Administration (FDA) for loteprednol etabonate ophthalmic suspension, 0.5%. Loteprednol etabonate 0.5% is indicated for the treatment of postoperative inflammation following ocular surgery and for the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis, and when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.
- IDOC has launched an enhancement to IDOC HR Services to streamline and standardize the process of hiring, developing, and managing qualified practice staff members. It was available to all members on April 29. It includes both a testing and a handbook service.
- Genetic Disease Investigators LLC announced receipt of its second patent, U.S. Patent No. 10,238,673 B2, addressing dry eye treatment via a unique avenue—the autonomic nervous system. This patent is in addition to U.S. Patent No. 9,271,953 for treatment of autonomic dysfunction.
- Aveo Vision announced the launch of Aveo Joy, a direct-to-consumer daily disposable contact lens specifically created for individuals who have astigmatism. Aveo Joy is is scheduled to \begin shipping in June 2019. Aveo Joy joins Aveo Hello, a daily disposable contact lens. According to the company, Aveo Joy features AquaLock for comfort; BlissEdge to keep the lens centered; SteadyView, a proprietary toric design combined with aspheric optics to eliminate distortion for sharp HD vision across the entire lens; and built-in Class II UV blockers to protect eyes from 97% of UVB and 87% of UVA radiation. The lenses are made from the omafilcon A lens material. All of Aveo’s contact lenses are cleared by the U.S. Food and Drug Administration. Cost is $55 per month ($45/month pre-order offer).