Voxeleron at ARVO 2024

ARVO is upon us, and we look forward to visiting the pacific northwest again this year! It is, without doubt, a unique conference allowing for both formal and informal get-togethers, all with the shared objective of advancing ophthalmic research. In preparation for this, we’d like to share some updates and do hope to get the chance to talk about them in person. Along those lines, we’re pleased to announce that our new CEO, Joanna Williams, will be attending. Joanna brings a wealth of expertise in business growth, service expansion and operational delivery. She was most recently a Co-founder and Chief Operating Officer at Lexitas, a preeminent ophthalmology Contract Research Organization (CRO). Given our focus on ophthalmic clinical trials, Joanna’s vision and leadership skills make her a welcome addition to the team.

Our industry is moving fast with a host of novel therapeutics being trialed. Our goal is a supporting role in this via iNebula, our cloud-based clinical trial image and data management platform and Orion, our ophthalmic image reading software. Together these are now proven in the industry to speed-up recruitment times and selection; facilitate faster decision making; generate more accurate and more timely structural endpoints; and accelerate work-flows.

To learn more, please visit our booth (#1720) where we’d be glad to update you further and also demonstrate our solutions. Below are brief summaries of our recent news.

ARVO Exhibitor Presentation

“Advanced Ophthalmic Imaging Analysis and Management: Tales from 3 Projects”

This presentation will cover three example use cases of iNebula and Orion:

• The first is from the perspective of a sponsor, presented by Dr. George Magrath.  This covers a retrospective analysis of data where, after study completion, Ocuphire needed a convenient, easy database to store images for future use in native formats with pertinent data attached to them.  Ocuphire is now using the images and data for many different stakeholders, hence a simple, easy, format agnostic methodology for presenting data was essential.
• The second is the more typical example of a clinical trial and how iNebula supports that.  Focus is on faster recruitment, site and reader work-flows, benefits of exploratory endpoints, the ability of sponsors to continually monitor and review their trial’s progress, and the subsequent cost- and time-savings associated with being more reactive to the continual updates.
• The third is specifically post-hoc analyses using AI-based methods of fluid segmentation, geographic atrophy segmentation, disease prognostics and a variety of custom algorithms that are applied to user data as part of a trial or a requested investigation.

Speakers will be:

• George Magrath, MD, Chief Executive Officer, Ocuphire Pharma
• Jonathan Oakley, Ph.D., Chief Scientific Officer, Voxeleron

Time: 3-3.30pm
Location:The exhibitor Education lounge, located in Exhibit Hall B.

Recent Webinars

In case you missed them, we have two customer-focused webinars that give you good insight into both iNebula and Orion.  They can be viewed from these pages, respectively:
https://voxeleron.com/phase-2a-dme-study-webinar/

“It’s important to actually have access to the data immediately because you can make adjustments in the trial and look at some of the variables…It was extremely important to get that data right then and there so we could do analysis through that. The system is terrific to be able to do that.”

• Sunil Patel, MD, Ph.D., Chief Medical Officer, Allgenesis Biotherapeutics (quote from the webinar)

https://voxeleron.com/ophthalmic-clinical-trial-watch-webinar/

“With this type of software package, we can start to say [to our sponsors] what do you want to know rather than what can you learn.  This is really changing that paradigm.  If you have a therapeutic that you would like to understand what part of the retina is being affected by it, we can now offer data to answer those questions.”

• Jason Slakter, MD, Medical Director, Voiant (quote from the webinar)

iNebula Updates

As a reminder, iNebula is the only truly vendor-neutral ophthalmic clinical trial management solution.  Images from any device can be uploaded in their native format and available for immediate review by anyone, anywhere in the world.  The platform is very image-centric, allowing fast perusal of all data in, depending on the view, thumbnail form.  This is very much appreciated by our users, and sponsors of trials in particular, as they now have real-time access to their trial data, facilitating earlier decision making, potentially measured in months.

“Over the past decade the Voxeleron team has assisted with numerous advanced image analyses, computer vision evaluations, and cross-platform standardization.  Recently, iNebula has provided a functional, easy, and simple interface for us to share image data from 103 study patients with various stakeholders in our development plan. A system like this is invaluable when managing large image datasets.”

• George Magrath, MD, CEO Ocular Pharma.

As with all our software, iNebula is developed in accordance with our ISO 13485:2016 company certification.  It is also GDPR and 21 CFR Part 11 compliant.  In terms of updates, the main two are:

• A notion of customizable work-states: all data is within a specific state (think “Needs IQR”, “Read” etc), and these states are displayed at all times.  Different states may be viewable by different users, and all states have specific transitions that are also permission gated.  As part of on-boarding, the client defines the workflow states and transitions, custom to their trial.
• A notion of tags or labels: some retrospective studies that are used to look at existing trial data benefit from labels that users may assign.  This supports review, re-reads and post-hoc analysis performed by the Voxeleron team.  And this includes a number of AI-based tools that can generate exploratory endpoints relative to the clinical markups that came from the initial study.

Critical to iNebula’s success is the ability to “read” any ophthalmic image, meaning generate accurate structural measurements from the data in a timely manner.  Which is, of course, the role of Orion.

Orion Updates

Orion is extensively validated, vendor agnostic, advanced ophthalmic image analysis software.  For clinical trials, it is best-in-class, and if that is not believed, please request a demo and then a trial!

“We are thrilled to partner with Voxeleron for our device-agnostic ophthalmic imaging analysis needs. Orion’s comprehensive capabilities and seamless compatibility with diverse imaging modalities have transformed our clinical trial operations. The intuitive interface and prompt support from the Voxeleron team have streamlined our processes, reducing reading times and boosting overall efficiency”

• Amy Jung Hyun Lee, PhD, CEO TI Image.

Recent updates include:

• Tighter integration with Orion: results auto-populate Orion, including quantitative measurements, as well as categorical measures.  These are all based on the requirements of the trial, so user-defined. The eCRF that populates iNebula is now viewable directly in Orion to allow customization of the automatic transcriptions.
• Color images may be filtered, enhanced, and viewed per color channel.
• Fundus images may have measurement grids placed directly on them for regional analysis.
• Additional OCT angiography data formats are supported.
• Further enhancements to the 2d segmentations of auto-fluorescence images.

But do note, that these are just recent updates.  Orion is feature-packed, a legacy of being in continual use across reading centers since 2013!

Voxeleron in the Press

Recent Papers:

“Validation of a deep learning model for automatic detection and quantification of five OCT critical retinal features associated with neovascular age-related macular degeneration”,  Ricardi F, Oakley J, Russakoff D, et al. British Journal of Ophthalmology Published Online First: 14 March 2024. doi: 10.1136/bjo-2023-324647

https://bjo.bmj.com/content/early/2024/03/14/bjo-2023-324647

“Deep-learning based automated quantification of critical optical coherence tomography features in neovascular age-related macular degeneration”, Borrelli, E., Oakley, J.D., Iaccarino, G. et al. Deep-learning based automated quantification of critical optical coherence tomography features in neovascular age-related macular degeneration. Eye (2023). https://doi.org/10.1038/s41433-023-02720-8

https://www.nature.com/articles/s41433-023-02720-8

Recent Presentations:

“Optic nerve head dimension as biomarker in Leber hereditary optic neuropathy”, Battista, Carbonelli, Coutinho et al. 2023 European Association for Vision and Eye Research Festival, 26-28 October 2023, Valencia.

“Utilization of Enface OCT and Deep Learning-Based Automated Segmentation to Quantify Area of GA: ECLIPSE study”, Sodhi, Orr, Oakley, Russakoff, Golding and Choudhry. Euretina 2023.

ARVO 2024 Presentations and Posters

And the following is a list of presentations that we have collaborated on for this year’s ARVO:

Optic nerve edema and pseudo-edema differentiation analysis using automated segmentation of fiber layer and blood vessels.
Marco Battista, Jonathan Oakley, Michele Carbonelli et al.

Posterboard#: A0326.  Abstract Number: 99 – A0326.  Sunday, May 5th, 8am to 9.45am.

Machine Learning Quantification of Fluid Volume in Eyes with Retinal Vein Occlusion Undergoing Treatment with Aflibercept: The REVOLT study.
Netan Choudhry, Niveditha Pattathil1, Mohammed Khan et al.

Posterboard#: A0287.  Abstract Number: 2395 – A0287.  Monday, May 6th, 3pm to 3.45pm.

And Finally

We hope that you have found these updates to be of interest.  This past year has allowed us to cement iNebula and Orion as a solution to reading centers and CROs alike as best-in-class solutions to both managing and analyzing ophthalmic image data, of any kind.

Again, we give recognition and appreciation to NCATS for their generous research and commercialization grant as well as their vision in seeing the need for better solutions in the ophthalmic imaging space.  This was done, of course, in the context of imaging in the eye being indicative of pathologies and diseases beyond just ocular ones, and NCATS were keen to support accelerating clinical research in these areas.

We also thank our customers for their business and their input that has helped us further develop our software.  Customer satisfaction is a priority, and we are grateful for each opportunity to prove that.

That just leaves us to say how much we look forward to ARVO and the opportunity to discuss any and/or all of the above topics with colleagues from around the globe. If you can’t make it, please do reach out via email.  We would be delighted to hear from you.  But if you can, feel free to book us at a time that fits your schedule: https://calendly.com/d/cj9y-tzb-bm6/meet-with-voxeleron

With best regards,

The Voxeleron team.