EW Weekly, January 15, 2021

Success with first-in-human implant of new artificial cornea
CorNeat announced the successful first-in-human implantation of its artificial cornea, CorNeat KPro. According to the company’s press release, the CorNeat KPRo “completely integrates with the eye wall with no reliance on donor tissue.” It was implanted in a 78-year-old male patient in Israel on January 3. After bandages were removed postop, the company stated the patient could read text and recognize family members.

Launch of first longitudinal study for home OCT
Notal Vision announced the launch of the first U.S. study of home-based OCT with the goal of evaluating patients’ ability to use the self-operated device to image their own eyes. According to the company’s press release, the study will take place at the Pepose Vision Institute, enrolling and monitoring 15 patients with wet AMD who are receiving anti-VEGF therapy for 90 days. The presence of retinal fluid will be tracked. Data from the Home OCT device, which was granted an FDA Breakthrough Device designation in 2018, is transmitted remotely to a secure cloud where AI-based technology identifies the presence of any intra- or subretinal fluid, according to the company. The investigators will have remote access to the Home OCT device through a web viewer. The company stated that the Notal Vision Diagnostic Clinic will also monitor patient compliance with imaging in the study and can provide remote support if needed.

Enrollment complete for study evaluating treatment for Leber congenital amaurosis 10
Patient enrollment is complete for ProQR Therapeutics’ Phase 2/3 pivotal trial evaluating the experimental treatment sepofarsen, an RNA therapy, for Leber congenital amaurosis 10. This condition is caused by genetic mutations and has no current root cause treatments; affected patients seek low vision aid, according to the company’s press release. Sepofarsen has Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA. According to the press release, the investigational drug, which is injected intravitreally, is “designed to enable normal splicing, resulting in restoration of normal (wild type) CEP290 mRNA and subsequent production of functional CEP290 protein.” Topline results are expected within the first half of 2022.

Phase 1/2a trial for wet AMD treatment with suprachoroidal injection begins enrollment
Clearside Biomedical announced that the first patient with wet AMD has been enrolled in its Phase 1/2a OASIS trial of CLS-AX (axitinib injectable suspension), which is delivered via a suprachoroidal injection. The trial is an open-label, dose-escalation study designed to primarily assess safety and tolerability of a single dose of CLS-AX at 3 months. Patients first receive aflibercept and a single dose of the investigational drug 1 month later at a second visit. Secondary endpoints, according to the company, involve pharmacokinetics, visual function, ocular anatomy, and need for additional intravitreal aflibercept. Data from the first cohort is expected mid-2021, according to the company’s news release.

Fast Track designation issued for investigational dry AMD therapy
Gemini Therapeutics announced FDA Fast Track designation for GEM103, an investigational treatment for dry AMD. GEM103 is a recombinant, human complement factor H (CFH) that, according to the company’s press release, has the ability to address multiple AMD pathobiologies in a genetically defined subset of patients with AMD caused by CFH loss-of-function variants, which are present in about 40% of patients with AMD. The company currently has an ongoing Phase 2a study evaluating the therapy in patients with geographic atrophy secondary to dry AMD.

Research highlights
  • A validation study of seven automated AI screening systems for diabetic retinopathy found that real-world results were not as good as those reported in controlled clinical studies of the systems. According to the study published in the journal Diabetes Care, one of the systems evaluated has FDA approval and others are under consideration/used in other countries. Performance of the AI screening systems was compared to that of human graders evaluating real-world retinal images from two U.S.-based VA health systems. The investigators reported high negative predictive values but widely varied sensitivities. Most of the algorithms, they continued, were no better than human graders (two had higher sensitivities, one comparable sensitivity and specificity). The authors advocated for rigorous testing of AI-driven detection systems with real-world data before clinical use.
  • A case study published in the journal Cornea is warning about improper use of UV germicidal lamps for “presumed household disinfection of SARS-CoV-2.” The report described phototoxicity induced by such a device in a family of three adults. They experienced photophobia, intense eye pain, epiphora, blurred vision, and a burning sensation on their face and neck. Three days after initial presentation, the authors noted improvement in the patients’ visual symptoms. The authors wrote that this case report “serves to emphasize the potential consequences of phototoxicity from the improper use of UV germicidal lamps for household disinfection and to highlight the fact that UV germicidal lamps currently have no established role in household disinfection of SARS-CoV-2.”

Product news
  • EYSUVIS (loteprednol etabonate ophthalmic suspension, Kala Pharmaceuticals) was launched and is now available by prescription in the U.S. for short-term treatment of the signs and symptoms of dry eye disease.
  • Roclanda (netarsudil and latanoprost ophthalmic solution, Aerie Pharmaceuticals) received marketing authorization (valid in 27 EU countries) from the European Commission. Roclanda, marketed as Rocklatan in the U.S., was FDA approved in March 2019.

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

For sponsorship opportunities or membership information, contact: ASCRS • 4000 Legato Rd. • Suite 700 • Fairfax, VA 22033 • Phone: 703-591-2220 • Fax: 703-591-0614 • Email: ASCRS Opinions expressed in EyeWorld Weekly do not necessarily reflect those of ASCRS. Mention of products or services does not constitute an endorsement by ASCRS.

Click here to view our Legal Notice.

Copyright 2021, EyeWorld News Service, a division of ASCRSMedia. All rights reserved.