- Tags: geographic atrophy
Products
FDA approves updated label for IZERVAY to treat GA
Astellas’s avacincaptad pegol now has no limitation on its dosing duration, enabling longer-term administration for patients with GA secondary to AMD.
Business
Bausch + Lomb adds to glaucoma and GA pipeline with two deals
Latest developments involve the acquisition of WhiteCap Biosciences and its GA candidate, as well as a partnership with RNAi-focused City Therapeutics.Products
FDA accepts revised sNDA of IZERVAY for GA
Company is requesting inclusion of 24-month data to extend approved dosage for an additional 12 months for both every-month and every-other-month dosing.
Business
Aviceda raises $207M to support phase 3 testing of AVD-104 for GA
Financing will support advancement of AVD-104, designed to target a specific area of the innate immune response relating to AMD.
Business
Tenpoint and Visus Therapeutics merge with plans for ophthalmic therapeutic advancements
Newly-combined Tenpoint Therapeutics, Ltd includes a pipeline featuring BRIMOCHOL PF, a once-daily eye drop for presbyopia targeting an NDA filing in 2025.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
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.
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
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.
Research
AREDS supplements may slow late-stage dry AMD progression
NEI-supported analysis identifies significant benefits based on new data from the AREDS and AREDS2 studies.
Pipeline
FDA clears 4DMT's IND for genetic GA treatment
Novel genetic medicine is formulated as a proprietary low-dose intravitreal AAV vector with plans for phase 1 clinical trial initiation expected in H2 2024.
Research
Four-year data supports PRIMA subretinal implant in GA patients
Subjects gained at least four ETDRS lines with this novel approach to vision restoration for geographic atrophy.
Research
Researchers update the AREDS Simplified Severity Scale
Findings from new post-hoc analysis modernize the AREDS Simplified Severity Scale with two key updates.
Research
GA growth rate linked to imaging biomarkers
New study investigates which multimodal imaging markers are associated with geographic atrophy.
Products
Astellas receives permanent J-code for IZERVAY
FDA-approved therapy is the first and only GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint.
Business
Nicox selects biotech exec for CEO as clinical focus shifts
Effective Feb. 29, Gavin Spencer, PhD, has taken the helm while the company announces corporate debt restructuring.
Pipeline
Aviceda reports topline data from SIGLEC trial for GA
Company reports AVD-104 demonstrating clinical and safety efficacy in part 1 of the phase 2/3 study.
Research
Algorithm predicts GA progression with near-perfect accuracy
Researchers used the deep learning-based model to scan SD-OCT images and provide a 94% accurate prediction.
Pipeline
FDA approves initiation of first inflammasome inhibitor trial for GA
Use of Kamuvudines via a sustained release delivery system could prevent the process that causes GA.
Research