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News updates for January 17, 2021.
With this week’s eye care update, I’m Gretchyn Bailey, editor in chief and content channel director of Optometry Times.
Kala Pharmaceuticals introduces Eysuvis (loteprednol etabonate) 0.25% for the short-term treatment of the signs and symptoms of dry eye disease. Eysuvis is now available in national and regional U.S. pharmaceutical distribution centers.
Kala has hired a team of 91 sales reps, with plans to expand to 125 reps in 2021, pending the status of the COVID-19 pandemic. In addition, Kala’s payor account team is actively engaged in contract discussions with Commercial and Medicare Part D health plans, according to the company.
With a refreshed logo, Essilor launches a new national television campaign for Varilux. The campaign will air nationwide in 2021 across TV providers, Hulu, YouTube, and more, driving awareness of the Varilux brand, defining the benefits of a progressive lens and compelling consumers to book an appointment.
With the new logo and branding system for Varilux, Crizal, and Eyezen, Essilor looks to develop stronger patient recognition and to help drive demand to eyecare professionals, according to the company.
Bausch + Lomb has initiated the second of two Phase 3 studies evaluating the investigational treatment NOV03 (perfluorohexyloctane) as a first-in-class investigational drug with a novel mechanism of action to treat signs and symptoms of dry eye associated with meibomian gland dysfunction. Enrollment of the first Phase 3 study is currently underway and has reached 85 percent of its enrollment goal.
NOV03 is a proprietary, water-free, and preservative-free solution based on patented EyeSol technology from Novaliq. In a Phase 2 study of 336 patients, NOV03 met its primary efficacy endpoint of statistically significant improvement of total corneal fluorescein staining over control at eight weeks, according to the company. In addition, NOV03 showed statistically significant improvement of severity and frequency of dryness and burning and stinging of the eyes with no notable safety events.
Johnson & Johnson Vision has released a new guide with recommendations for eyecare professionals to assess, monitor, and treat myopia in children. The guide, titled “Managing Myopia: A Clinical Response to the Growing Epidemic,” is a result of a year of collaboration with organizations in optometry, including the American Optometric Association, American Academy of Optometry, Association of Schools and Colleges of Optometry, and Singapore Optometric Association.
Genentech announced positive topline results for Phase III YOSEMITE and RHINE studies evaluating faricimab, the first investigational bispecific antibody designed for the eye, in diabetic macular edema.
In the YOSEMITE and RHINE trials, faricimab met the primary endpoint measuring the average change in best-corrected visual acuity score from baseline at one year compared to aflibercept.
In both studies, faricimab was generally well-tolerated with no new safety signals identified.
Alcon has commercially launched AcrySof IQ Vivity, the first and only non-diffractive extended depth of focus intraocular lens in the U.S.
Vivity provides an extended range of vision from distance to near without increasing the incidence of visual disturbances, according to the company. Alcon’s proprietary non-diffractive X-WAVE technology stretches and shifts light without splitting it, allowing Vivity to provide high-quality vision at distance and intermediate focal points as well as functional near vision.
According to Alcon, Vivity is a presbyopia-mitigating IOL option for patients who are not candidates for a diffractive IOL platform, but want more spectacle independence.
Aldeyra Therapeutics announced announced positive top-line symptom, redness, and Schirmer’s test results from the run-in cohort of the Phase 3 TRANQUILITY clinical trial in patients with dry eye disease.
Patients received four doses of 0.25% reproxalap or vehicle one day prior to and two doses on the day of exposure to a 90-minute dry eye chamber with minimal humidity, high airflow, and forced visual tasking.
Patients receiving reproxalap scored higher on two assessed symptoms, visual analog scale ocular dryness score and ocular discomfort score. Consistent with previously announced allergen chamber Phase 2 clinical trial results, reproxalap demonstrated statistically significant improvement over vehicle in ocular redness. Improvement in ocular symptoms and redness occurred within minutes after reproxalap dosing. No adverse findings were observed, and reproxalap was well-tolerated.
The main cohort of TRANQUILITY is expected to begin enrollment in February 2021, and results are expected in the second half of 2021. A second Phase 3 clinical trial, TRANQUILITY-2, is expected to initiate in the first quarter of 2021.
CooperVision has launched a social media contest encouraging eyecare professionals to be more sustainable in their practices and daily lives. The “Planet-Loving Practices Sustainability Contest”—which runs through the end of January—features weekly winners on CooperVision’s social media platforms, supported with additional marketing to increase visibility of participating practices.
To enter, eyecare professionals from across the country must share photos or videos on their social media channels showcasing how they are environmentally responsible at work or at home and tag three of their colleagues using #claritiForThePlanet.
Haag-Streit unveils Lenstar Myopia, the company’s Lenstar 900 optical biometer and corresponding software EyeSuite Myopia.
EyeSuite Myopia uses new axial length growth curves and was developed in cooperation with myopia experts. Lenstar 900 provides precise axial length measurements and keratometry to myopia management practitioners.
The latest update of the virtual eye science game, CORE Knowledge 2.0, is now available at COREKnowledgeGame.org. Nearly 100 new topics were added, and the leaderboard was reset to make way for a new champion.
The online game debuted at ARVO 2018 and presents competitors with multiple choice questions covering basic and clinical ocular research topics. Participants race a two-minute clock to correctly answer as many questions as possible before time runs out.
The game was conceived and developed by the Centre for Ocular Research & Education (CORE).
Test your knowledge at COREknowledgegame.org.
Ocuphire Pharma has completed enrollment earlier than expected in its MIRA-2 Phase 3 registration clinical trial evaluating the safety and efficacy of Nyxol to reverse pharmacologically-induced mydriasis.
VisionQuest Biomedical has received 510(k) clearance from the U.S. Food & Drug Administration to market Image Quality Analyzer (IQA) software, which reduces unreadable images captured in teleretinal screening programs by retinal photographers.
IQA is a software system intended for use in analyzing and managing images acquired with digital fundus cameras. It detects the most common causes of retinal imaging artifacts: bright crescents, blurriness, and poor illumination. The software then prompts the user to retake the image and provides clues for improving the image quality. The software can be used with both tabletop and portable retinal cameras.
IQA will also power two of VisionQuest’s pipeline products: EyeStar and ASPIRE. EyeStar detects diabetic retinopathy, while ASPIRE uses a smartphone imaging device and artificial intelligence software to detect malarial retinopathy, a highly specific sign of cerebral malaria. Neither EyeStar nor ASPIRE have been cleared by the FDA.
NuSight Medical has introduced NuLids Revitalize Eyelid Gel. The Eyelid Gel has been formulated from natural ingredients known to soothe, hydrate, and protect ocular tissues, according to the company. It has been developed both as a companion product for use with the NuLids System and as a standalone product to provide relief.
Norlase has received the European CEMark for the LION green laser system. LION combines the Keeler Vantage Plus diagnostic indirect ophthlamoscope with Norlase’s compact laser technology into one device. LION features an untethered and portable design.
The CE Mark approval follows the October 2020 510(k) market clearance of LION by the U.S. Food and Drug Administration.
Hilco Vision has acquired Illinois-based M&S Technologies, effective December 31, 2020. M&S Technologies produces digital vision testing systems, and Hilco Vision manufactures professional optical tools and ophthalmic supplies. The business will continue to be based in Illinois, according to the company.
Now, I talk with Dr. Chris Wroten about the recent COVID-19 stimulus bill.