EW Weekly, September 4, 2020

Continuous IOP-monitoring device gets Breakthrough Device Program designation
The FDA granted Injectsense a Breakthrough Device Program designation for its IOP Connect system, an implantable, continuous IOP monitor. The company describes this device as smaller than a grain of rice and injected into the eye in a 5-minute, in-office procedure. According to the company’s press release, the technology is still in research and development, but this breakthrough designation gives it priority review with the FDA for its continued development, clinical trial protocols, and commercialization decisions. So far, IOP Connect has been successfully tested in animals, and in-human studies are expected to begin in the spring of 2021.

Visual prosthesis brain implant research to begin
The Illinois Institute of Technology is embarking on a 3-year clinical trial for a first-of-its-kind wireless visual prosthesis that bypasses the retina and optic nerve entirely, a press release from the institute announced. The Intracortical Visual Prosthesis (ICVP) System will connect directly to the visual cortex to help patients without any sight visualize rendered images, the press release said. This research is part of the National Institute of Health’s Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative.

Phase 3 clinical trial investigating port drug delivery system
Genentech announced the start of its Phase 3 Pavilion multicenter, randomized, clinical trial that is investigating its Port Delivery System (PDS) with ranibizumab for patients with diabetic retinopathy. According to the company’s press release, the PDS is a permanent, refillable implant that delivers a continuous, customized formulation of ranibizumab over several months. The Phase 3 trial will look at safety, efficacy, and pharmacokinetics in patients with diabetic retinopathy without diabetic macular edema who will be randomized to receive either the PDS with refills at 9 months or to the comparator observation arm, the latter of which will be eligible to receive the PDS at month 16 for 9-month refills thereafter. The primary endpoint, according to Genentech, is the percentage of patients achieving a two-step or more improvement in diabetic retinopathy severity from baseline at week 52 measured by the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale.

Six-month results from trial evaluating OMNI Surgical System
The 6-month results from a trial evaluating the OMNI Surgical System in patients with open angle glaucoma were released from Sight Sciences. The OMNI Surgical System uses an ophthalmic viscoelastic device (OVD) to perform a canaloplasty and ab interno trabeculotomy. This study was prospective, multicenter, and controlled, enrolling 150 patients with mild to moderate open angle glaucoma who were on one to four glaucoma medications. Interim results showed a 75% reduction in glaucoma medications in the first 76 patients who reached 6 months post-OMNI treatment. Of these initial patients, 73% did not need any glaucoma medications at 6 months post-OMNI treatment. According to the company’s press release, patients who were medication-free after the OMNI treatment saw an average IOP reduction of 40% compared to the unmedicated washout baseline IOP; 95% saw a more than 20% reduction in IOP with a range of IOP between 6–18 mm Hg. Hyphema (4.6%), IOP spike (2%), vitreous hemorrhage (1%), and iritis (1%) were reported as adverse events. The company reported these events to be minor and requiring no additional treatment for complete resolution.

Feasibility for cultivated autologous limbal epithelial cell transplantation established
Harvard Medical School/Mass Eye and Ear announced the successful transplantation of cultivated autologous limbal epithelial cells in four patients who had chemical burns. According to a news article published on Harvard Medical School’s website about the ongoing clinical trial researching cultivated autologous limbal epithelial cell (CALEC) transplantation, four of five patients who were enrolled thus far received CALEC treatment and no longer had pain from their chemical injury. With no adverse events in these initial patients, the news update stated that more patients will be recruited in the second phase into 2021. The article explains that safety, feasibility, and outcomes (improved vision) will continue to be investigated by the research team at Harvard Medical School, Mass Eye and Ear, Boston Children’s Hospital, and Dana-Farber Cancer Institute.

20/Happy in 2020: ASCRS launches master class
ASCRS has begun “20/Happy in 2020: The ASCRS Master Class in Refractive Cataract Surgery,” which includes 18 AMA PRA Category 1 Credits TM as well as non-CME symposia that attendees can view live or watch later. Every other week, live symposia will be aired on Saturdays, avoiding conflicts with clinic and OR time. At the conclusion of the multi-week master class, participants will receive a frameable certificate. A total of nine CME modules will cover topics including preoperative diagnostics, IOL calculations, IOL design, patient selection, education, and counseling, efficiency, and more, with discussion and expertise provided by a faculty of 80 surgeons from around the world. Sessions will consist of lectures, audience Q&A, and live panel discussions. Attendees who don’t attend sessions live will have the opportunity to watch recorded versions. Learn more and register at https://ascrs.org/20happy.

Research highlights
  • Teleophthalmology in a combat zone was evaluated in a recently published study. The case series published in JAMA Ophthalmology described how, ultimately, mobile phone teleophthalmology in 28 consults in Afghanistan prevented some aeromedical evacuations, with 54% of consults being allowed to return to duty. The study took place from September–November 2019 among 16 military treatment facilities with the use of a mobile eyecare app and an expeditionary ophthalmologist who was stationed at a military hospital in Afghanistan. The mean initial response time with the app was 3 minutes, 58 seconds and median overall satisfaction with the secure and compliant app was 5 on a scale where 5 was deemed to be “very satisfied.” Agreement between the teleophthalmology diagnosis and the final diagnosis, according to the study, was reached in 86% of consults.
  • Small incision lenticule extraction (SMILE) in patients with corneal guttae was evaluated in a study published in Clinical Ophthalmology. The retrospective analysis included 12 eyes from six patients who had SMILE for myopia. All eyes in the study achieved UDVA of 0 logMAR or better, and none developed corneal edema or other complications in the 12-month postop period. The study found no significant change in endothelial cell density, coefficient of variation, or percentage of hexagonal cells. This led study authors to conclude that SMILE “yielded improvement in visual acuity and no adverse effects to corneal endothelial cells were found when correcting myopia or myopic astigmatism in patients with [corneal guttae].” The authors acknowledge the need for a larger study with longer follow-up to further establish safety and outcomes.
  • A cross-sectional study investigated the presence of SARS-CoV-2 RNA in tears of moderate to severe COVID-19 patients, finding that there is a significantly higher possibility of viral transmission through tears in this patient population. The study included 78 cases (75 of which were ultimately included for analysis). Of these, 36 were moderate COVID-19 cases and 39 were severe. None of these patients had ocular manifestations of the virus, according to the study authors. PT-PCR of the tears, however, found the virus in 18 (24%) of patients. The study evaluated different methods of tear collection for this viral analysis and established conjunctival swab to be the “gold standard of tear collection for RT-PCR assay.” The research is published in Ophthalmology.

  • Product News
    • The IOLMaster 700 (Carl Zeiss Meditec) issued software update 1.90 with central topography and improvements for workflow efficiency.
    • Topcon launched its Aladdin-M in the U.S., which combines corneal topography, pupillometry, and optical biometry.

    This issue of EyeWorld Weekly was edited by Stacy Jablonski and Vanessa Caceres.

    EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), is published every Friday, distributed by email, and posted live on Friday.

    Medical Editors: Eric Donnenfeld, MD, Chief Medical Editor; Rosa Braga-Mele, MD, Cataract Editor; Clara Chan, MD, Cornea Editor; Nathan Radcliffe, MD, Glaucoma Editor; and Vance Thompson, MD, Refractive Editor

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