AMD

Screening patient for AMD
#AMD #Complement Therapeutics #FDA #Geographic atrophy

FDA fast tracks geographic atrophy treatment 

The US Food and Drug Administration (FDA) has granted Fast Track Designation for a treatment for  geographic atrophy (GA) secondary to age-related macular degeneration (AMD).  CTx001, developed by biotechnology company Complement Therapeutics, is a novel adeno-associated virus (AAV)-based gene therapy designed… Read More

#News #Regulatory

Screening patient for AMD
#AMD #Clinical trial #Complement Therapeutics #FDA #Gene therapy #Geographic atrophy #Ophthalmology

FDA clears gene therapy trial in geographic atrophy

The US Food and Drug Administration (FDA) has cleared Complement Therapeutics’ Investigational New Drug (IND) application for CTx001, the company’s lead gene therapy candidate.   The IND clearance enables initiation of the Opti-GAIN Phase I/II clinical trial in patients with geographic atrophy (GA) secondary to age-related macular degeneration… Read More

#News #Regulatory

Eye
#Age-related diseases (ARDs) #AMD #Fast Track designation #FDA #Ophthalmology #Sanofi

FDA fast-tracks Sanofi’s AMD gene therapy

Sanofi’s investigational one-time intravitreal gene therapy for the treatment of neovascular age-related macular degeneration (AMD) has been granted fast track designation by the US Food and Drug Administration (FDA).   Sanofi’s SAR402663 is currently being evaluated in a Phase I/II clinical trial for patients with neovascular AMD. Read More

#News #Regulatory

Human eye
#AMD #Monoclonal antibodies #Ophthalmology #Outlook Therapeutics #Scottish Medicines Consortium (SMC)

Bevacizumab gamma gets Scottish OK for wet AMD

The Scottish Medicines Consortium (SMC) has approved Lytenava (bevacizumab gamma) for the treatment of wet age-related macular degeneration (wet AMD).   It is the first licensed ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the EU and the UK and has an initial… Read More

#News #Regulatory

Eye
#AMD #Endogena Therapeutics #FDA #Geographic atrophy #Ophthalmology

FDA gives green light for AMD treatment trials

The US Food and Drug Administration (FDA) has granted clearance for Endogena’s Investigational New Drug (IND) application for EA 2351, a potential treatment for geographic atrophy (GA). GA is an advanced form of age-related macular degeneration (AMD). The first-in-human study is set to commence in 2024. Read More

#News #Regulatory

Structure of the eye
#AMD #Boehringer Ingelheim #CDR-Life #Collaboration #Geographic atrophy #Ophthalmology #Phase I trial

Antibody treatment for geographic atrophy enters clinical trials

Collaborators Boehringer Ingelheim and CDR-Life have commenced a Phase I evaluation of BI 771716, their antibody fragment-based treatment developed to preserve the vision of people with geographic atrophy (GA). Boehringer Ingelheim and CDR-Life entered a licensing agreement in May 2020 and announced the… Read More

#Editor's Choice #News

Eye
#AMD #Drug targets #Louisiana State University #Neuroscience #Ophthalmology

Discovery provides new therapeutic approaches to AMD

New research suggests that age-related macular degeneration (AMD) decreases an essential fatty acid, preventing the formation of a class of protective molecules and reducing repair potential – a discovery that may open new therapeutic avenues for AMD. The study shows that AMD decreases peripheral retinal docosahexaenoic… Read More

#News

Test for AMD
#AMD #Astellas Pharma #FDA #Geographic atrophy #Ophthalmology

FDA approves Izervay for geographic atrophy

The US Food and Drug Administration (FDA) has approved Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The new complement C5 inhibitor is the only approved GA treatment with a statistically significant reduction in the rate… Read More

#News #Regulatory

Eye
#AMD #Aviceda Therapeutics #Geographic atrophy #Nanomedicine / nanotechnology #Ophthalmology #Phase II trial

Novel glycan-coated nanoparticle enters trials for geographic atrophy

Aviceda Therapeutics has dosed the first patient in its Phase II SIGLEC trial investigating AVD-104 as a treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). AVD-104 is a novel glycan-coated nanoparticle, supported by a strong pre-clinical in vivo efficacy and safety profile. Read More

#News