- tags:geographic atrophy
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
Clinical perspective from AAO: Day 2
Michael Ammar, MD, offers a clinical look at the day’s top sessions and key research, including big news from two FDA-approved treatments.Products
Two-year data reported for GATHER2 study on Izervay
Phase 3 study results indicate a continued reduction in GA lesion growth.
Research
Three-year data supports extended treatment of Syfovre for GA
Phase 3 GALE study results indicate a continued reduction in GA lesion growth.
Pipeline
FDA clears Endogena's IND for GA investigational compound
A first-in-human study for EA-2351 is set to kick off in 2024.
Products
Positive 24-month data released for phase 3 trials on Syfovre
Latest data supports the FDA-approved therapeutic for treating GA.
Pipeline