- Phase 4 trial for thyroid eye disease begins
- Glaukos submits supplemental pre-market approval application for iStent infinite
- Gene therapy for Leber hereditary optic neuropathy receives milestone designation in U.K.
- ASCRS news and events
September 10, 2021 • Volume 27, Number 36
Phase 4 trial for thyroid eye disease begins
Horizon Therapeutics announced that it began a Phase 4 clinical trial to evaluate safety and efficacy of TEPEZZA, currently the only FDA approved treatment for thyroid eye disease. According to the company, the trial will be randomized, double-masked, placebo-controlled, parallel-group, and multicenter. Participants in the study will be at least 18 and have a thyroid eye disease diagnosis for at least 3 years but less than 8 years. The company reported that participants will be randomized to receive a 2:1 ratio of TEPEZZA infusions (10 mg/kg for the first and 20 mg/kg for the remaining seven infusions) or placebo. The primary endpoint is change from baseline at week 24 in proptosis. Other metrics that will be assessed include proptosis responder rate, diplopia responder rate, change in orbital pain, change in muscle volume, and quality of life.
Glaukos submits supplemental pre-market approval application for iStent infinite
Glaukos submitted a supplemental pre-market approval application for the iStent infinite Trabecular Micro-Bypass System, currently an investigational device designed as a standalone procedure to reduce IOP. According to the company’s press release, the device is designed for patients with open angle glaucoma with IOP uncontrolled by prior surgical or medical therapy. The system includes three heparin-coated titanium stents preloaded into an injector. Glaukos explained that the stents are injected within up to 6 clock hours around Schlemm’s canal. A prospective, unmasked, multicenter, single-arm clinical trial of iStent infinite, which included 72 participants who received the stent system, showed that at 12 months, 76% of subjects had a 20% or greater reduction in IOP from baseline, which was 23.4 mm Hg. There was also a 13% reduction in medications from baseline, which was 3.1 medications. Glaukos reported favorable safety and tolerability of the device, with no explants, infections, device-related interventions, or hypotony within the 12-month postop period.
Gene therapy for Leber hereditary optic neuropathy receives milestone designation in U.K.
GenSight Biologics announced that it received a Promising Innovative Medicine designation from the U.K.’s Medicines and Healthcare Products Regulatory Agency for LUMEVOQ. LUMEVOQ, a gene therapy for vision loss due to Leber hereditary optic neuropathy caused by a mitochondrial gene mutation, has an orphan drug designation with the U.S. FDA. Earlier this year, the company announced positive topline results from its Phase 3 clinical trial in the U.S. and said it plans to submit full results to the FDA as part of its ongoing Marketing Authorization Application for LUMEVOQ. The treatment’s Marketing Authorization Application is also under review at the European Medicines Agency with a decision expected in 2022, according to the company’s press release.
ASCRS news and events
- ASCRS Journal Club: Plan to join ASCRS’ interactive Journal Club on Thursday, September 23 from 9:00–10:00 p.m. ET for another session in this monthly series where a panel of experts discuss two pre-selected manuscripts from the Journal of Cataract & Refractive Surgery (JCRS). Learn more.
- 2022 Annual Meeting: ASCRS is accepting submissions for courses, papers, posters, films, and photos until October 11. Visit the Call for Submissions website for more information about the submission process.
- ASCRS Glaucoma Building Blocks: Registration is open for a limited time for this complete on-demand CME series in comprehensive glaucoma management. Learn more and register for this program to strengthen your foundation in modern glaucoma management.
- CME opportunity: “ASCRS Satellite CME: Supplemental Education to the ASCRS Annual Meeting” includes four, 1-hour programs captured from the 2021 Annual Meeting that are now available online and on-demand for viewing/claiming credit. Learn more.
Research highlights
- A retrospective chart review compared operative time, ultrasound time, efficacy, and safety of phacoemulsification cataract surgery conducted with halogen or LED illuminated microscopes. More than 200 charts were included in the review; 113 cataract cases were conducted with a halogen microscope (OPMI Lumera S7, Carl Zeiss Meditec) and 114 with an LED microscope (Proveo, Leica Microsystems) by the same surgeon. The mean ultrasound time difference between the two groups (−2.69±8.44 seconds) was not statistically significant. Total operative time was 19.83±4.77 minutes in the halogen group and 17.20±3.02 minutes in the LED group, for a mean difference of 2.63±0.53 minutes, which the authors reported was statistically significant. In the halogen group, 93.69% of cases achieved a BCVA of 20/30 or better compared to 95.49% in the LED group. Intraoperative complications were 3.53% in the halogen group and 2.63% in the LED group and not statistically significant. The authors concluded that an LED microscope could benefit productivity but reiterated that there was no statistically significant difference in ultrasound time, efficacy, or safety among cataract cases conducted with LED or halogen microscopes. The research is published in Clinical Ophthalmology.
- A retrospective cohort study published in the British Journal of Ophthalmology evaluated rates of keratoconus progression in children and teens 18 and younger. Corneal tomography with the Orbscan (Bausch + Lomb) was used to determine progression in 148 eyes of 106 patients who were followed up for a mean of 2.9 years. The rate of progression was 77%. According to the paper, eyes that progressed showed more advanced disease presentation (higher anterior curvature, posterior elevation, and lower central pachymetry measurements). Factors that were not statistically significant for progression were age at presentation, gender, atopy, eye rubbing, ethnicity, and duration of follow-up. The authors reported a higher rate of bilateral progression if at least one eye had severe keratoconus.
This issue of EyeWorld Weekly was edited by Stacy Jablonski and Liz Hillman.
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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