Geographic Atrophy

Researchers find gray GA lesions had the highest cross-modality differences

According to the company, it is anticipating cost savings of up to $300 million through 2024, which includes an estimated 25% reduction in current workforce and a reduction in external expenses.

The company believes the 19-gauge filter needles may be the culprit in the SYFOVRE injections.

According to the company, the MAA submission is based on data from the GATHER1 and GATHER2 Phase III clinical trials.

Staging AMD accurately and identifying clinical features that are linked with disease progression are key.

According to the company, the therapeutic is the only approved GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials.

Data from the 30 month GALE extension study indicated that continuous treatment with pegcetacoplan injection showed increasing beneficial effects over that timeframe in patients with geographic atrophy (GA).

The companies are partnering to advance a novel therapy with the goal of preserving sight for people living with blinding retinal disease.

In presentations at the American Society of Retina Specialists 41st Annual Meeting in Seattle, additional analyses support consistent protection from vision loss.

During presentations at the American Society for Retina Specialists 41st Annual Meeting in Seattle, the company noted that there was no indication that drug product or manufacturing issues contributed to rare events of retinal vasculitis.

Cochair Peter J. McDonnell, MD, highlights what this year’s conference will mean for clinicians and addresses the anticipated increased patient volume.

According to the ASRS Research and Safety in Therapeutics Committee, ophthalmologists noted instances of intraocular inflammation (IOI) after the initial injection of pegcetacoplan.

The complement system identifies and eliminates pathogens and dying cells, 3 pathways can activate the complement system—classical, lectin, and alternative—and their activation results in similar functions of opsonization, inflammation, and cell lysis.

The company has completed evaluation on candidates and selected a single drug candidate to move forward into clinical trials.

CT1812 is an experimental, oral therapy for the treatment of geographic atrophy secondary to dry age-related macular edema.

Data supports ANX007 as the first complement therapy to preserve visual acuity, achieving statistically significant protection, but reduction in rate of geographic atrophy lesion growth did not reach statistical significance.

According to the company, topical administration is capable of delivering metformin to choroid, RPE, and retina.

Data demonstrate a reduction in the loss of retinal pigmented epithelial and photoreceptor cells.

Analysis signals up to 59% risk reduction in rate of vision loss compared with sham treatment at 12 months.

According to the companies, Boehringer Ingelheim will use RetinAI’s tools to develop treatments for GA, applying the company’s artificial intelligence tools to its imaging data in a search for novel biomarkers and predictors of disease progression.

The GA Won’t Wait campaign is designed to help older adults and their families understand and recognize the symptoms of this progressive and irreversible disease.

One way to advance the current understanding of GA is to study how disease progression varies among related individuals.

Industry leaders view pegcetacoplan as most important retinal technology in 10 years.

According to the company, post-hoc time-to-event analysis signals up to 59% risk reduction in rate of vision loss compared to sham treatment at 12 months. The analysis will be presented at the ARVO Annual Meeting from April 23-27 in New Orleans.

Ophthalmologists see new therapy as having a major impact on how geographic atrophy is treated.

Apellis received FDA approval for intravitreal pegcetacoplan (SYFOVRE) to treat geographic atrophy secondary to AMD. This news follows the submission of the 24-month phase 3 data in November 2022.

According to a news release, Akari is targeting an Investigational New Drug application submission to the FDA in the first half of 2024.

In a presentation at the 2023 Angiogenesis, Exudation, and Degeneration program, Usha Chakravarthy, PhD, FRCOphth, CBE, presented data from the trial of lampalizumab, which is peeling back some of the mystery shrouding geographic atrophy.