ARVO Cornea Abstracts Assess Dry Eye Disease And Current Events
The Association for Research in Vision and Ophthalmology (ARVO), which occurred virtually from May 1 to May 7, revealed a chunk of cornea abstracts that evaluated dry eye disease (DED) and current events, such as digital device use and mental health. Here’s a snapshot of these abstracts, which can be read in their entirety, along with other insightful cornea-related posters, at https://arvo2021.arvo.org/abstracts :
• Minority Populations Have Worse DED
Minorities (racial and ethnic) presented with worse DED criterion, potentially resulting from socioeconomic barriers and lack of recognition of the condition, which leads to providers prescribing differential treatment, according to “Disparities in Dry Eye Severity and Access to Dry Eye Care in Racial and Ethnic Minorities.”
The study was comprised of 464 patients (156 White, 85 Asian, 157 Black, and 66 Hispanic individuals).
▲ Smartphone Use Causes DED Symptoms; Disrupts Blink Rate in Children
The use of a smartphone for 60 minutes quickly resulted in DED symptoms and a slowed blink rate, reported “One Hour of Smartphone Use Induces Ocular Discomfort and Reduces Blinking in Children.”
The study was made up of 45 children, ages 6 to 15 (mean 10.1±2.6 years; 20M:25F) who had healthy eyes and no binocular vision issues.
▲ Video Display Terminal Use Not Linked With OSDI or Numerical Rating Scale of Ocular Pain Scores
The time spent using video display terminals (VDT) was not related to OSDI or numerical rating scale of ocular pain scores, underscoring the need for the additional investigation of DED diagnostic devices in VDT users, reported “Relationship Between Time Spent Using Video Display Terminals and Dry Eye Disease.” That said, a trend toward reduced computer use with increased ocular pain was noted, perhaps causing the loss of productivity in this group. DED treatment has a high rate of success in patients who have ocular pain linked with VDT use, the researchers said.
The study was made up of 144 patients, with a mean age of 58.1 years.
▲ Worse DED Symptoms and Signs Associated With Depression
DED symptoms and signs were worse in moderate to severe DED patients who screened positive for depression, reported “Association Between Depression and Severity of Dry Eye Symptoms and Signs Among Patients in the Dry Eye Assessment and Management (DREAM) Study.” That said, depression was more strongly linked with symptom severity vs. clinical signs of DED, “which may be related to the discordance between symptoms and signs of DED,” the researchers said.
The study was comprised of 535 patients who had moderate to severe DED.
COVID-19 Can Directly Infect Eye, Study Shows
The human eye can be directly infected by SARS-CoV-2 and, therefore, warrants protection, reveals a study in Stem Cells Transl Med.1
Specifically, the researchers found that the limbus was most sensitive to infection, and the central cornea exhibited low replication levels.
The researchers arrived at these findings after performing RNA sequencing in ocular cells separated from adult human cadaver donor eyes, and from a pluripotent stem cell-derived whole eye organoid model to assess ACE2 and TMPRSS2 expression, which are essential proteins that mediate SARS-CoV-2 viral entry. Additionally, the researchers infected the adult human ocular cells and eye organoids and with COVID-19, and assessed both virus replication and host response to infection.
Reference
- Stem Cells Transl Med. doi: 10.2139/ssrn.3650574 preprint.
ORGANIZATION SPOTLIGHT: AMERICAN REFRACTIVE SURGERY COUNCIL
FOUNDED: 2008. “The Refractive Surgery Council was formed by industry leadership in 2008 to provide consumers with an independent educational resource about laser vision correction options,” says Jim Wachtman, Chairman of the ARSC.
PURPOSE: To provide consumers with information, so they can make an informed decision regarding refractive surgery, and the choices available. The information is provided by industry representatives and medical professionals who are experienced in developing, researching and employing the technologies and techniques for refractive surgery, the ARSC says.
“Surgeons can refer patients and prospects to the ARSC with the assurance it gives them access to clinically accurate, evidence-based, and medically reviewed information about laser vision correction to support the prospective patient in making the right decision for their eye health and vision,” notes Mr. Wachtman.
MEMBERSHIP: To join the ARSC’s verified list of practices, visit www.bit.ly/RSCVerified .
“Once enrolled, practices have access to ARSC’s many resources, including patient-friendly educational content, and insights driven by ARSC’s proprietary market data.”
Transparent Corneal Inlay May Join List of Presbyopia Treatments
Patients who have presbyopia have the option of optimizing their vision via glasses, multifocal contact lenses, premium IOLs and intracorneal inlays. Thanks to a team of researchers from the Universitat Politècnica de València (UPV), the Universitat de València, and the Aiken Ophthalmic Clinic Research Foundation, a completely transparent trifocal corneal inlay could be added to this list of options, according to the UPV.
The totally transparent diffractive inlay is comprised of a biocompatible material and “is extremely thin — less than 5 μm — so, it would be inlayed inside the stroma of the cornea, basically without affecting its structure, in a cavity created with a femtosecond laser,” explains Walter D. Furlan, researcher at the Department of Optics and Optometry and Vision Sciences at the Universitat València to UPV. “ The lens is micro-perforated, which allows the flow of necessary nutrients in this part of the cornea.”
Vicente Ferrando, a researcher at the Center for Physical Technologies of the UPV, adds that the nutrients flow associated with this inlay is large, which “would reduce the chances of rejection once inlayed in the cornea of the patient.”
Something else to consider: Some of the inlay’s design parameters may be adapted, allowing for customization for each patient, according to the UPV.
The researchers are now looking at starting clinical trials in presbyopic patients.
Artificial Endothelial Layer Created to Cancel Need for Donor Tissue
EyeYon Medical and medical device entrepreneur Nahum Ferera, created a ready to-use, universally available dome-shaped, curved 50 μm endothelial graft called EndoArt to eliminate the requirement of donor tissue for corneal edema treatment, reported The Ophthalmologist.
The graft is comprised of a clear, foldable, biocompatible co-polymer that has the strength to facilitate insertion and intraocular manipulation — sans the risk of graft damage — and covers roughly 40% of the cornea’s area, blocking excessive aqueous humour penetration from one side, while allowing corneal nutrition from the other side, EyeYon says.
EndoArt is placed into the anterior chamber through a clear, roughly 2.2 mm incision, and then unfolds and attaches to the posterior corneal surface via an air bubble technique. At this point, it can be manipulated by the surgeon as needed.
The implant is undergoing clinical trials in Asia, Europe and Israel. EyeYon could not be reached for comment regarding U.S. clinical trials.
Study Seeks to Determine Which Diabetic Patients Can Donate Cornea
Case Western Reserve University (CWRU), University Hospitals, and the Jaeb Center for Health researchers will perform a study to determine the diabetic individuals who can donate their corneas for successful keratoplasty. The study comes on the heels of mounting research that shows not all corneal tissue from diabetic individuals may be acceptable for keratoplasty, even though roughly a third of corneal transplants involve donated corneas from diabetic individuals, according to a CWRU press release.
“…This study could… help identify some of the reasons why 2% to 3% of donated corneas fail for no apparent reason, which is a reason for frustration among patients and surgeons,” said Ahmed Omar, an assistant professor at the CWRU School of Medicine and director of the Cornea Service at University Hospitals Eye Institute, in the press release.
Specifically, the Diabetes Endothelial Keratoplasty Study seeks to:
- Compare the one-year keratoplasty success rate post-Descemet membrane endothelial keratoplasty (DMEK) with corneas from donors with and without diabetes. (DMEK is being employed, as it’s the most common procedure, which should help with patient recruitment efforts, and due to prior research, which reveals eye-bank technicians have had more issues preparing donors who have diabetes for the DMEK surgery, according to the press release.
IMAGE COURTESY STOCK.ADOBE.COM / RICHELLE - Compare the one-year loss of endothelial cells in the central cornea post-DMEK in corneas from donors with and without diabetes.
- Explore how diabetes severity of a donor affects outcomes one year post-DMEK.
The study will be comprised of 1,420 donors, and over 1,000 patients, with two-thirds of donors non-diabetic and one-third diabetic. Additionally, diabetes in the transplant recipient will be watched to understand how that may influence procedure success. Further, 16 eye banks and 30 U.S. clinical sites will be involved.
The study’s researchers received a 5-year, $6.4 million grant from the National Eye Institute for the study, along with support from the Eye Bank Association of America, the Cornea Society, the Cleveland Eye Bank Foundation, and many national eye banks, according to the press release.
ALSO NOTEWORTHY
- American Academy of Ophthalmology published a report urging ophthalmic imaging device manufacturers to standardize image formats to adhere to the Digital Imaging and Communications in Medicine standard. This recommendation has been endorsed by The American Society of Retina Specialists, the Asia-Pacific Academy of Ophthalmology, the Royal College of Ophthalmologists, and the Royal Australian and New Zealand College of Ophthalmologists. The report can be accessed at: www.aaojournal.org/article/S0161-6420(21)00164-0/fulltext .
- Alcon has launched its Systane Hydration Multi-Dose Preservative-Free artificial tears in the United States. The drops use the company’s proprietary HydroBoost Technology, and are designed for dry eye disease patients who use drops frequently (defined as more than q.i.d.), plus post-surgery patients. The drops are now available at major pharmacies in 13 countries, with more launches planned throughout 2021.
- Bausch + Lomb’s (B+L) ClearVisc dispersive ophthalmic viscosurgical device (OVD) received FDA approval for use in ophthalmic surgery. The OVD, supplied in a 1.0 ml syringe, aids in ensuring tissue visualization, maintains anterior chamber space throughout all phases of lens removal and IOL insertion, and is easily removed during irrigation/aspiration, the company says. Further, it helps provide physical protection of the cornea from thermal and mechanical damage, and provides chemical protection from damaging free radicals, B+L says. In other news, B+L and Novaliq GmbH, a biopharmaceutical company focusing on ocular therapeutics, announced the results of their first Phase 3 trial evaluating the investigational drug NOV03 (perfluorohexyloctane) for the treatment of the signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction. Specifically, the trial met both its co-primary endpoints, including change from baseline in total corneal fluorescein staining, and change from baseline in dryness score. Additionally, the trial met all its secondary endpoints, showing statistically significant improvements in both the signs and symptoms of DED associated with MGD, the companies say.
- CorNeat Vision, a clinical-stage, biomimetic implant and technology company, and LiveU, a live video-streaming and remote production company, partnered for and implemented an on-demand Remote Surgeon Virtual Presence (RSVP) solution through Alcon’s NGENUITY 3D Visualization System to perform the remote supervised hands-on training of Canadian cornea experts at the Kensington Eye Institute in Toronto, without leaving Israel. The RSVP, which allowed for the first implantations of the CorNeat KPro artificial cornea, provides up to 4 K video resolution in subsecond latency, and is made up of a portable field unit and a decoder that bonds up to 16 cellular connections, multiple Wi-Fi networks, and a local area network to create a single managed high-bandwidth connection that is optimized for video streaming.
- Eversight named Diane Hollingsworth president/CEO, effective immediately. She has served as interim president/CEO since March 5, and will work with Eversight’s leadership to create the long-term strategy of addressing the changing eye-banking landscape and guide the organization, Eversight says. Visit www.eversightvision.org .
- Eyenovia announced that its VISION-1 Study, evaluating the company’s pilocarpine formulation, MicroLine, for the temporary improvement of near vision in adults with presbyopia, achieved its primary endpoint with a statistically significant proportion of subjects showing a 3-line or more improvement in distance-corrected near visual acuity vs. placebo in low-light conditions at 2 hours post-treatment, the company points out. Eyenovia says preparations are underway for VISION-2, a second Phase 3 registration study.
- Euclid Systems Corporation announced that EUCLID MAX, from EUCLID Systems, is approved for the temporary reduction of myopia. “Building on Euclid’s proprietary lens designs, Euclid MAX features an innovative material with a Hyper Dk of 180... without the compromise of lens stability. This is especially important with young healthy eyes in the closed eye environment,” said Euclid Systems’ CEO Joseph Boorady. “We are very proud and excited to introduce this combination of outstanding material characteristics and proven lens designs, which will help more patients successfully manage their myopia.”
- Glaukos Corporation secured a global exclusive license to use Intratus’ drug delivery platform for application in the treatment of presbyopia. Glaukos acquired a global exclusive license to use Intratus’ therapeutic platform to treat glaucoma and dry eye disease, among other corneal disorders.
- Johnson & Johnson Vision (J&J) announced that the FDA and Health Canada approved the company’s TECNIS Synergy and TECNIS Synergy Toric II IOLs for use. In a company-sponsored study, 9 out of 10 patients who received TECNIS Synergy IOL lenses did not need glasses after surgery. The full TECNIS Synergy IOL family — first launched in Europe and Asia Pacific in 2019 — will be available across North America. In other news, the company announced that the FDA approved ACUVUE Abiliti Overnight Therapeutic Lenses, an orthokeratology contact lens for the management of myopia. The lens will be available in two different designs: Abiliti Overnight Therapeutic Lenses, and Abiliti Overnight Therapeutic Lenses for Astigmatism. The Abiliti lenses are optimized by the use of corneal topography, refractive error, and other measurements connected to a fitting software, J&J says. The lenses are expected to be available in the United States by the end of 2021. For more information, visit www.seeyourabiliti.com .
- Katena Products, Inc. announced it has bought ASICO, LLC, the maker of ophthalmic surgical instruments. ASICO’s product line includes more than 1,500 items, such as stainless steel and titanium instruments, single-use cannulas and blades, and a selection of diamond knives.
- Lumenis Ltd. announced that the FDA granted De Novo authorization for the company’s newest IPL device Opti-Light with the company’s patented Optimal Pulse Technology. OptiLight has a spectrum of 400 nm to 1200 nm, and is indicated for improvement of dry eye disease signs, due to meibomian gland dysfunction.
- Nevakar Inc., a biopharmaceutical company, announced the creation of Vyluma Inc., a company with a focus on the development and commercialization of ophthalmic disease therapies. Vyluma will operate as a wholly owned subsidiary of Nevakar Inc., and set its sights on first-in-class and best-in-class ophthalmic pharmaceutical therapies, with an emphasis on refractive errors, the company says. NVK-002 is Vyluma’s lead product candidate in late Phase 3 clinical development. Vyluma’s pipeline includes programs for the treatment of pediatric myopia, presbyopia, night vision disturbance, acute ocular pain, and hyperopia.
- OCULUS announced the availability of the OCULUS LidStick, created for manipulating the lids for dry eye disease measurements, slit lamp exams, cornea-scleral surface detection, and more. The LidStick is approved for medical use, and is single use and individually wrapped. In other news, the OCULUS Pentacam AXL Wave received FDA 510(k) clearance. Visit www.pentacam.com/axl-wave .
- Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on developing a pharmaceutical solution for presbyopia symptoms, appointed Paul Smith president and CEO. Mr. Smith, who worked for Novartis, TearLab and Alcon, will initiate the global expansion of Orasis from a development-stage company into a commercial organization, with an immediate emphasis on U.S. presence, the company says.
- OSRX, a compounding pharmacy focused on postop cataract and refractive procedures, glaucoma management, and myopia control, has named Eric Garner chief commercial officer. Mr. Garner is responsible for everything from sales strategy, sales force automation initiatives and customer service, to national strategic marketing/communications plans, and implementation.
- Oyster Point Pharma, Inc., announced the FDA accepted its New Drug Application (NDA) for OC-01 (varenicline) nasal spray for dry eye disease signs and symptoms. OC-01 is a highly selective cholinergic agonist shown to activate the trigeminal parasympathetic pathway in the nasal cavity to stimulate tear film production.
- Quantel Medical launched a dry eye disease (DED) in-formation website to assist patients in better understanding the condition, its symptoms, its causes, diagnosis, and treatments for management. The website will be updated monthly with a news item relating to DED and the season, or another related topic, such as DED, and screen use. English: www.mydryeyedisease.com , Spanish: www.miojoseco.es , and French: www.masecheresseoculaire .
- Surface Ophthalmics named Preeya K. Gupta, MD, former “Guest Editor” of Corneal Physician, chief medical advisor. In this role, she will consult with Surface Ophthalmics’ leaders and share expertise, especially in dry eye disease (DED), to help guide the company’s 3 clinical programs: SURF-100 (chronic DED), SURF-200 (acute DED) and SURF-201 (pain and inflammation post-ocular surgery), the company said.
- SynergEyes released the SynergEyes iD Just For You Patient Starter Kit. The kit includes lenses, a reusable bag, a pocket mirror, a lens-handling and care brochure, and space for a lens case, and care solution. Visit https://synergeyes.com/new-synergeyes-id-patient-resources/ .
- Tarsus Pharmaceuticals, Inc., a late clinical-stage biopharmaceutical company, announced it has started enrollment in Saturn-2, the company’s second trial assessing its TP-03, in patients who have Demodex blepharitis. TP-03 is a topical ophthalmic formulation of lotilaner, an anti-parasitic agent created to target and eradicate Demodex mites. Saturn-2 is a randomized, controlled, multicenter, double-masked trial evaluating the safety and efficacy of TP-03 in adults who have Demodex blepharitis. The trial’s primary endpoint is the proportion of patients who reach collarette cure, defined as 0 to 2 eyelashes with collarettes. Dr. Elizabeth Yeu recently covered TP-03 in her article “Blepharitis: Know When Demodex is the Culprit,” which can be accessed at https://bit.ly/3yBtaer . CP
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