Apellis Pharmaceuticals reported topline results from the phase 3 DERBY and OAKS studies evaluating intravitreal pegcetacoplan, an investigational targeted C3 therapy, in 1,258 adults with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Based on results from the studies, the company plans to submit a new drug application (NDA) for pegcetacoplan for GA to the FDA in the first half of 2022.
Oertli Launches Updated Faros Surgical Platform
Oertli has updated its Faros surgical platform with new LED technology. The compact device for anterior and posterior segment surgery provides 45% more light output, and ensures optimal illumination and visualization, according to a company news release. Oertli’s Faros device performs cataract, vitrectomy, and glaucoma surgery. The precise flow control of the peristaltic pump is designed to make the surgeon’s work simple …
MeiraGTx Announces Data at EURETINA 2021 Demonstrating Reversal of Disease Progression Following Treatment With AAV5-RPGR in XLRP
MeiraGTx Holdings announced new data from subjects treated in the phase 1/2 dose escalation phase of Study MGT009 indicating AAV5-RPGR, an investigational gene therapy in development for the treatment of X-linked retinitis pigmentosa (XLRP), reverses course of disease progression when retinal function assessed 12 months following treatment with AAV5-RPGR is compared with retinal function in these same subjects up to …
Sustained-release glaucoma therapies on the horizon
The need for sustained-release glaucoma therapies is clear to anyone caring for patients with the disease. Our conventional topical therapies have a number of toxic effects on the external ocular tissues. There are physical and medical limitations to eye drop instillation in our generally older patient population. The time and scheduling demands of drop instillation and pharmacy visits are intensive. …
Horizon Therapeutics Initiates Phase 4 Clinical Trial Evaluating Tepezza for the Treatment of Chronic Thyroid Eye Disease
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 …