- tags:retina
Research
Researchers test ChatGPT on retinal disease clinical guidelines
ChatGPT accurately answered questions related to medical retinal care, but struggled with surgical conditions.
Pipeline
Alkeus receives two rare disease FDA designations for Stargardt candidate
New statuses join gildeuretinol’s (ALK-001) previous Fast Track and Orphan Drug designations; gives company potential eligibility for priority review voucher.
Research
Could RNFL changes and vessel density detect pseudoexfoliation glaucoma?
RNFL damage may be more noticeable than vascular density changes.
Pipeline
FDA clears HuidaGene's IND for CRISPR RNA-editing nAMD therapy
HG202 is now the only clinical-stage RNA-targeting therapy in clinical development for nAMD, with an upcoming phase 1 trial slated for Q2 2025.
Pipeline
FDA extends Neurotech's BLA PDUFA date for MacTel therapy
Review period of NT-501, an encapsulated cell therapy, now has a target date of March 2025.
Business
AlloVir and Kalaris to form retinal disease-focused company
Merger focuses on advancing clinical development of TH103, a novel differentiated anti-VEGF investigational therapy for nAMD.
Pipeline
FDA grants Fast Track designation to Feliqs' ROP prevention candidate
New status targets lead asset FLQ-101, a small-molecule and lipid modulator designed as a once-daily oral/intravenous solution for preventing disease development.
Pipeline
Tarsus releases new phase 2 data on TP-03 for MGD
Latest findings on lotilaner ophthalmic solution, 0.25% reported during AAOpt demonstrate promise for improving gland function and reducing ocular itching and redness.
Products
FDA grants authorization to LumiThera's Valeda system for dry AMD
Approval makes the photobiomodulation treatment the first device of its kind to treat vision loss among dry AMD patients.
Research
Investigators receive $6.4M NEI grant for AMD oral candidate
The $6.4 million in funding will support the clinical development of an advanced, small molecule drug with dual specificity.
Pipeline
Genentech reports phase 4 Vabysmo data among underrepresented DME patients
Study is referred to as the first retinal trial to focus on this patient demographic, finding similar average vision gains to prior research.
Pipeline
EyePoint doses first patient in global phase 3 wet AMD trial of Duravyu
LUGANO study is evaluating the continuous durability of the vorolanib intravitreal insert when injected every 6 months versus aflibercept.
Pipeline
RevOpsis receives NEI grant for advancing retinal vascular disease candidate
The $1.8M funding will support clinical development of RO-104, a fully human modular tri-specific biologic targeting three angiogenic pathways for wet AMD.
Business
Ocuphire Pharma just purchased Opus Genetics
Operating under the name “Opus Genetics,” the combined company features a pipeline of IRD-targeted gene therapy candidates.
Pipeline
RegenxBio reports positive phase 2 bilateral wet AMD data
Nine-month clinical findings noted a 97% reduction in treatment burden following subretinal delivery of gene therapy treatment.
Products
Zeiss showcases expanded ophthalmic portfolio of digital tools
Company introduces new AI-based software solutions and highlights technologies from its Cataract and Retina Workflows as well as two new microscopes.
Pipeline
Beacon Therapeutics reports positive 24-month phase 2 XLRP gene therapy data
Latest findings demonstrate AGTC-501 to be generally safe and well-tolerated, with a 57% response rate noted among high-dose-treated eyes.
Business
Mediwhale raises $12M in funding for AI-based retinal scanning tech
Financing will support the company’s AI diagnostic solutions for preventing cardiovascular, kidney, and ocular diseases.
Pipeline
Clearside Biomedical reports positive topline phase 2b data on CLX-AX for wet AMD
A reduced treatment burden was noted in 84% of participants over 6 months, demonstrating the TKI’s prolonged duration and targeted delivery.
Pipeline