- tags:AMD
Products
FDA issues company response letter to Astellas for IZERVAY supplemental NDA
Agency rejects proposal for positive 24-month data to be included in prescribing information; clarifies no issue with safety and benefit/risk of use.
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.
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.
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
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.
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.
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.
Business
Opthea appoints new CFO, other senior leadership positions
Latest appointees include CMO and VP as the company prepares for 2025 topline phase 3 data readouts on sozinibercept for wet AMD.
Pipeline
Despite missing primary outcomes, Alkea’s phase 3 GA trial shows promise
Oral gildeuretinol's clinically meaningful reduction in GA lesion growth warrants further clinical development, company says.
Business
Opthea names senior leaders ahead of phase 3 wet AMD data readout
Company anticipates releasing interim data from COAST and ShORe studies in early and mid-2025, respectively.
Business
Samsara Vision promotes industry veteran to COO
Former VP Jason Herod will oversee ongoing U.S.-based trials on the SING IMT intraocular telescope for late-stage AMD.
Research
Lampalizumab injections lead to low IOP risk for GA
A recent study examined the IOP safety of intravitreal lampalizumab and the rate of ocular adverse events.
Pipeline
Lupin reports positive phase 3 program for Lucentis biosimilar
Global clinical data on LUBT010 determined clinical equivalence between the two, supporting an eventual regulatory submission for FDA approval.
Products
FDA approves Sandoz's EYLEA biosimilar for wet AMD
Approval of Enzeevu (aflibercept-abzv) is expected to be key in growing the company’s U.S. biosimilar-based ophthalmic portfolio.
Pipeline
Annexon releases phase 2 and 3 clinical developments for GA therapeutic
New findings from ARCHER and ARCHER II trials support the potential for ANX007 to be the first therapeutic approved for vision protection.
Legal
LumiThera receives first CPT code for retina-based PBM therapy
New Category III code applies to the Valeda Light Delivery System, intended to treat dry AMD.
Pipeline
First patients enrolled in Ocular Therapeutix phase 3 wet AMD study
New SOL-R trial intends to provide real-world evidence supporting the potential for axitinib intravitreal implant redosing every 6 months.
Products