Geographic Atrophy, Deep Dive

Happy Monday from RetinAI! Welcome to another edition of the Healthcare in Motion Newsletter, the free Newsletter that helps you access the latest news in healthcare, ophthalmology, AI and beyond!

Today, let's explore the most relevant news related to Geographic Atrophy. But first, let's have a quick definition.

What is Geographic Atrophy (GA)?

Geographic Atrophy (GA) is a chronic progressive degeneration of the macula, the advanced form of age-related macular degeneration (AMD), most commonly of dry AMD. GA leads to areas of the retina experiencing cell death (atrophy), resulting in blind spots in the visual field.

GA can affect one or both eyes but a patient with GA in one eye is more likely to develop the disease also in the other eye. Major risk factors are: increasing age, family history of AMD and smoking history.

The vision loss caused by GA severely impairs the patients’ quality of life and independence in conducting daily activities. Over 8 million people are affected worldwide with GA, approximately 20% of all individuals with AMD. The incidence of GA is expected to rise as the age-burden of developed countries is increasing1.

First treatment for GA finally approved

Up until a few months ago, GA remained an untreated condition. However, there has been a recent breakthrough with the approval of SYFOVRE? (pegcetacoplan injection) developed by Apellis Pharmaceutical, by the U.S. Food and Drug Administration (FDA), making it the first and only FDA-sanctioned treatment for GA.

The new drug was approved based on positive results from the Phase 3 OAKS and DERBY studies at 24 months across a broad and representative population of patients. Those studies show that SYFOVRE reduced the rate of GA lesion growth compared to sham and demonstrated increasing treatment effects over time, with the greatest benefit (up to 36% reduction in lesion growth with monthly treatment in DERBY) occurring between months 18-24. The drug has a well-demonstrated safety profile following around 12''000 injections over 24 months.

SYFOVRE was approved on February 17th for GA patients with or without subfoveal involvement and provides dosing flexibility for patients and physicians with a dosing regimen of every 25 to 60 days.

SYFOVRE has been available since March through specialty distributors and pharmacies across the U.S.. A marketing authorization application for the drug is under review by the European Medicines Agency with a decision expected in early 2024. In addition, a marketing application has been submitted to Health Canada.

Second treatment for GA on the way?

Iveric Bio’s Zimura (avacincaptad pegol), an inhibitor of complement C5, thought to be a key driver of GA, is showing positive results from its two pivotal, independent Phase III trials, Gather 1 and Gather 2. To know more about these two studies, click here.

Zimura’s new drug application (NDA) was accepted and its Prescription Drug User Fee Act (PDUFA) date is August 19, 2023. ?

After this the deluge

Following Apellis and Iveric Bio’s trail, Aviceda Therapeutics pioneers the usage of sugars to modulate the inflammatory system and is developing an intravitreal therapeutic that resolves chronic inflammation and complement activation that will profoundly halt progression of GA without causing conversion to exudative AMD and with less frequent injections.

Several other companies active in Ophthalmology are also looking at the space, with both traditional and gene therapies.?

RetinAI & Classification of Atrophy Group (CAM)

The Classification of Atrophy Meeting (CAM) Group is an expert working group, consisting of more than 30 members, focused on identifying biomarkers in GA. At the end of last year, our collaboration with the CAM group began, with the main goal of providing our Discovery? platform to facilitate peer-to-peer data collaboration and perform accelerated, automated biomarker analysis of real-world datasets of geographic atrophy (GA) patients.?

After using Discovery at the CAM 8 Annual Meeting in February 2023, the CAM group decided to continue leveraging Discovery functionalities at the upcoming CAM 9 scientific meeting, to help organize real-world datasets and facilitate the group’s analysis of key research questions resulting from discussions and analysis at CAM 8.

Read more about this promising collaboration in our latest Press Release.

AI for GA - Opportunities & Challenges?

In this newsletter from Retinal Physician, Alan Kimura , MD, MPH, shares his view on the role of AI in GA management.

‘’An effective AI-imaging model has the potential to augment clinical management decisions in GA. Personalized information predictive of imminent, visually-threatening disease progression from GA might reduce wasteful over-processing of patients in overburdened clinics struggling to supply the demand for retinal services’’

However, despite the significant opportunity that AI and advanced analytics promise not only for GA management but for the healthcare in general, Alan Kimura recalls the main challenges for AI application in clinical settings, among which the often low power of generalization of AI algorithms and patient and clinicians acceptance of these new technological tools.

RetinAI for GA - Enhanced GA insights with RetinAI Discovery?

RetinAI is committed to develop digital precision medicine solutions that help physicians and healthcare professionals find the right treatment for the right patient at the right time.

Among the digital precision medicine solutions recently developed, our AI technology for GA, currently available on Discovery and through Device Systems (e.g. Heidelberg Engineering’s AppWay).

The technology is based on research findings from three published papers in GA (read more here).?

Some of the opportunities that will arise from this first-of-a-kind product:

• Automatic AI-based patient progression prediction. Slow vs. fast progressors in GA.
• Multi-modal AI-based analysis via OCT & FAF.
• Time to foveal involvement & simulation of atrophy growth for physician/patient education and increased engagement.

*Data from Dr. Robyn Guymer AM

• Define intermediate AMD population subgroups for GA analysis
• High granularity analysis of quantified biomarkers?
• Longitudinal biomarker tracking of patients

RetinAI for GA @ARVO

We? were thrilled to have five abstracts accepted for poster presentations at the Association for Research in Vision and Ophthalmology (ARVO) conference in April 2023.?

These abstracts highlighted the use of RetinAI’s Discovery? platform and its AI models in recent studies across several retinal diseases, including GA. Indeed, one of the studies tested RetinAI’s advanced segmentation tools used to quantify layer thicknesses in a-scans to show differences in the presence of Geographic Atrophy (GA).

With Discovery's advanced segmentation tools, clinicians can now segment multiple layers and pinpoint where atrophy begins and resides. This technology has the potential to support doctors in understanding GA better and enable further research into the disease.

You can read more about the abstract in our dedicated press release.

Here some pictures from our posters sessions’ on April 23rd at ARVO 2023:

We will also have in-booths presentations at ARVO, booth #719, and a special spotlight on Geographic Atrophy on Monday, April 24th at 10:30AM CDT presented by Sandro De Zanet , Chief Scientific Officer at RetinAI . Seats for each in-booth presentation are limited, so register now to secure your spot ?? click here

We look forward to seeing you at booth #719!

That’s all from this special edition on Geographic Atrophy! Don't forget to leave a comment below to extend this conversation ??