Galimedix Therapeutics presents baseline data from Phase 2 eDREAM trial highlighting patient-tailored microperimetry as a sensitive and precise functional measurement in geographic atrophy studies

Galimedix Therapeutics presents baseline data from Phase 2 eDREAM trial highlighting patient-tailored microperimetry as a sensitive and precise functional measurement in geographic atrophy studies

• Data presented at EURETINA 2026 support high repeatability of patient-tailored microperimetry (MP) for functional evaluation in geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD)
• Assessments performed with MP demonstrated to be robust and potentially outperform current functional measurements in GA
• Combining MP with optical coherence tomography (OCT) demonstrated the potential of this approach in predicting areas of reduced or absent vision

Kensington, MD, USA, and Munich/Martinsried, Germany, October 1, 2026 – Galimedix Therapeutics, Inc. (“Galimedix”), a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and brain diseases, today announced that data from its ongoing Phase 2 eDREAM study evaluating GAL-101 in geographic atrophy (GA) are being presented at the 26th EURETINA Congress. Using baseline data, the results demonstrate the robustness of patient-tailored microperimetry (MP) for multimodal assessment of retinal function in patients with GA and support Its further evaluation as a highly sensitive functional measurement in GA studies.

“Geographic atrophy is a complex neurodegenerative disease of the retina, and advancing new therapies requires both innovative treatment approaches and sensitive, clinically meaningful tools to measure their impact,” said Yaniv Barkana, MD, Chief Medical Officer of Galimedix. “For this reason, we incorporated patient-tailored microperimetry to measure retinal function in the eDREAM study. To our knowledge, this is the first reported use of this tool in a prospective clinical trial in geographic atrophy. We are delighted that initial results from our study demonstrate the potential of this procedure to provide a more precise functional measurement, helping to better capture changes in retinal function and support the development of future disease-modifying treatments, such as GAL-101.”

Data from the eDREAM study are being presented in several oral presentations and posters at EURETINA. More details are available here.

Patient-tailored MP demonstrates robustness and potential advantages over current functional measurements in GA

MP is a specialized vision test that measures sensitivity at specific retinal locations (loci) of the macula. In eDREAM, following the first screening visit, a patient-tailored lesion-specific grid is created based on each patient’s retinal imaging to plot test points around the atrophic area. This individualized sensitivity map can then be directly compared with imaging of the underlying retina, enabling a more precise assessment of how structural changes relate to functional vision loss.

As a first step, repeatability and test-retest characteristics were analyzed via three independent tests that took place at two separate visits:

• Results demonstrated good short-term repeatability in this cohort
• As employed in eDREAM, this procedure was well managed by all parties.

These findings support the robustness of patient-tailored MP for functional assessment in GA clinical trials.

Other functional baseline measurements assessed in the eDREAM study

In two visits separated by a few weeks, the following baseline functional tests were performed and compared: 1) best-corrected visual acuity (BCVA), a standard eye chart test done with the best possible refractive support to measure visual sharpness; 2) low-luminance visual acuity (LLVA), the same eye chart test performed under dim light to stress the retina; and 3) microperimetric sensitivity in five central foveal points.

• All three assessments showed no systematic bias in the two repeat tests
• The tests were complimentary.  For example, BCVA was the most precise but showed the least reliability.
• Defining baseline as the mean of two tests markedly reduced measurement error, suggesting duplicate testing should be the default design for trials using these important assessments in macular disease.

Linking retinal structure with functional vision loss

To further assess the potential of patient-tailored MP, clinicians correlated structural changes in the retina, determined by OCT such as layer thickness, length of area of damage or area of atrophy, with changes in point-wise retinal function measured with MP:

• Readings were able to show that damaged light-sensing cells or photoreceptor disruption (PRD) occurred in the same location as damage to the supporting retinal pigment epithelium (RPE) layer underneath them. This accurate co-localization strongly predicted focal scotomas, areas of low or no vision.
• Other structural measures, such as outer nuclear layer, provided critical data regarding local tissue function, particularly within structurally compromised points.
• Also, MP detected a high prevalence of discordant loci, points in the retina where the structural appearance and the measured visual function did not match, highlighting the complex pathophysiological heterogeneity of the peri-atrophic region.

These findings further support the value of tailored-grid methodology for functional mapping and suggest incorporating continuous OCT metrics or severity grading rather than relying on simple binary structural classification. Finally, standardized thickness units remain essential to accurately translating these anatomical coefficients into clinically meaningful functional outcomes.

The eDREAM data presented at EURETINA 2026 provide new evidence supporting patient-tailored MP as a sensitive and precise functional readout in GA and its potential role in future clinical studies.

About eDREAM
The eDREAM study (NCT06659549) is a Phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating GAL-101 eye drops in patients with geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD). The study is designed to assess the efficacy and safety of GAL-101 eye drops and their potential to slow disease progression in patients with GA. The trial is planned to enroll 110 patients across clinical sites in the US, Europe, and Israel, with participants randomized 1:1 to receive GAL-101 eye drops or placebo.

The primary endpoint evaluates the reduction in the rate of change of GA lesion size, determined by fundus autofluorescence (FAF). A secondary endpoint will evaluate the rate of change in the area of photoreceptor degeneration by optical coherence tomography (OCT). Additionally, the study is evaluating the functional measures of retinal sensitivity through microperimetry using a patient-tailored grid design. The study design was developed in collaboration with leading retina experts and has been discussed with regulatory authorities.

About GAL-101
GAL-101 is a small molecule being developed for the treatment of dry age-related macular degeneration (AMD), glaucoma, and Alzheimer’s disease in both oral and topical (eye drops) formulations. GAL-101 is an amyloid beta (Aβ) aggregation modulator. It targets misfolded Aβ monomers and thus prevents the formation of toxic Aβ oligomers and protofibrils at source. Many studies have indicated that these Aβ aggregates are a major underlying cause of neurodegenerative diseases of the brain and retina, and recent approvals of anti-Aβ drugs have also validated them as a key target in Alzheimer’s disease.

In pre-clinical testing, the compound has been shown to prevent and eliminate all forms of toxic Aβ species while leaving healthy Aβ forms intact. Strong efficacy has been demonstrated in relevant ophthalmic pre-clinical models, protecting neuronal retinal cells from toxic damage. GAL-101 has also demonstrated the potential for neuroprotection and for symptomatic alleviation in pre-clinical models of Alzheimer’s disease.  In Phase 1 testing, both the oral and eye drop forms of GAL-101 demonstrated an excellent safety and tolerability profile. Orally available GAL-101 has shown very low systemic toxicity, robust storage stability, and easy and inexpensive manufacturing. In addition, oral GAL-101 was shown to effectively cross the blood-brain barrier.

About Galimedix Therapeutics, Inc.
Galimedix is a Phase 2 clinical-stage private company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and brain diseases. Founded by a seasoned and highly dedicated team of bio-entrepreneurs, pharmaceutical executives and scientists, Galimedix’s groundbreaking small molecules offer the hope of changing the course of disease where amyloid beta plays a role, such as in dry age-related macular degeneration, glaucoma and Alzheimer’s disease - Galimedix’s initial areas of focus. For more information, visit www.galimedix.com and follow us on LinkedIn.
 

Contact

Alexander Gebauer, MD, PhD
Galimedix Therapeutics, Inc.
Co-founder and Executive Chairman
info@galimedix.com

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