Horizon Therapeutics announced that the first patient has been enrolled in a phase 4 clinical trial evaluating the efficacy and safety of Tepezza for the treatment of chronic (inactive) Thyroid Eye Disease (TED). Tepezza is the first and only medicine approved by the FDA for the treatment of TED—a serious, progressive and potentially vision-threatening rare autoimmune disease.
Bottling Presbyopia Correction
Death, taxes … and presbyopia? One of the few certainties in life, presbyopia is an inevitable part of the natural aging process. Although tools to mitigate the effects of presbyopia are accessible (but seemingly always disappearing [ahem, readers]), several companies are working to develop pharmaceutical solutions to address the condition. This article overviews some products in development.
Low-Level Light Therapy
This procedure is a simple and effective option for treating meibomian gland dysfunction. Many options are available for the treatment of meibomian gland dysfunction (MGD), but most insurance plans cover only pharmaceuticals. Low-level light therapy (LLLT) is a low-cost entry point to MGD management. It is effective both as a standalone procedure with the Equinox (Espansione Group) and in combination …
GenSight Says RESTORE Study of Lumevoq Shows Sustained Efficacy 3 Years After Unilateral Treatment
GenSight Biologics reported Aug. 31 that the Journal of Neuro-Ophthalmology (JNO) had published results from a long-term follow-up study of the gene therapy candidate Lumevoq that show sustained, bilateral treatment effect three years after a unilateral injection.The RESTORE study followed 61 patients with Leber hereditary optic neuropathy (LHON) due to a mutated ND4 mitochondrial gene.Paris-based GenSight said subjects in the …
Byooviz Becomes First Ranibizumab Biosimilar Approved in EU
The European Union has approved its first ranibizumab biosimilar, Byooviz, a Samsung Bioepis product that references Lucentis.The approval was handed down Aug. 18 by the European Commission, based on recommendations from the European Medicines Agency (EMA).Byooviz was approved for treatment of wet age-related macular degeneration, visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, visual impairment due to macular …
UCLA researchers receive $1 million to develop novel CAR T-cell therapies for melanoma
Cristina Puig-Saus, PhD, and Daniel S. Shin, MD, PhD, of UCLA Jonsson Comprehensive Cancer Center received a $1 million award from the U.S. Department of Defense for research into novel cell therapies for rare melanomas. The Translational Research Award is intended to help the researchers advance the development of chimeric antigen receptor T-cell therapy for patients with acral, mucosal or uveal melanomas. These rare …
Glaukos Submits Supplemental Pre-Market Approval Application for iStent Infinite
Glaukos announced that it has submitted a supplemental pre-market approval (PMA) application to the FDA for the iStent infinite Trabecular Micro-Bypass System. The iStent infinite is an investigational device designed for use in a standalone procedure to reduce elevated IOP in patients with open-angle glaucoma uncontrolled by prior surgical or medical therapy. It includes three heparin-coated titanium stents preloaded into an auto-injection system that allows the …
Sleeping Off Diabetic Retinopathy
Sharing results from a real-world single center study of patients with diabetic macular oedema (DMO) who wore a home-use sleep mask (Noctura 400) for 12 months PolyPhotonix, the manufacturer of the Noctura 400 – a treatment for diabetic retinopathy – recently completed a realworld study at an NHS hospital in the UK, which began in 2019. The study analyzed the …
AI-supported test can predict eye disease that leads to blindness
In a clinical trial of 113 patients led by researchers at Imperial College London and UCL, retinal imaging technology called Detection of Apoptosis in Retinal Cells (DARC) was able to identify areas of the eye that were showing signs of geographic atrophy (GA) – a common condition that causes reduced vision and blindness.The researchers believe that this technology could be …
iStent inject safe, efficacious in open-angle glaucoma
The iStent inject was safe and effective for treating multiple types of primary open-angle glaucoma individually and in conjunction with cataract surgery, according to data published in Journal of Cataract and Refractive Surgery.
