Alkeus Pharmaceuticals released additional Phase 2 clinical trial (SAGA) data for gildeuretinol, an oral treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Patients treated with gildeuretinol experienced slower declines in vision-related quality of life and functional reading scores compared to those receiving a placebo. This data was presented at the 2025 Association for Research in Vision and Ophthalmology Annual Meeting.
This news offers significant hope for individuals experiencing GA, a debilitating condition leading to central vision loss and impacting daily activities like reading and driving. Demonstrating a functional benefit strengthens the case for gildeuretinol’s therapeutic value beyond simply slowing disease progression, a critical consideration for patients and clinicians. This builds upon previous positive data from the TEASE program evaluating gildeuretinol for Stargardt disease, another retinal condition sharing a similar disease mechanism with GA. This suggests gildeuretinol may address an unmet need for both conditions.
In the SAGA study, gildeuretinol showed a clinically meaningful trend in slowing GA growth rate of 13.4% over 24 months (p=0.075), with a statistically significant reduction of 15.3% from 6 to 24 months (p=0.047) in a sensitivity analysis. It also significantly improved low luminance visual acuity, with 4.4 fewer letters lost over 24 months (p=0.031), and showed a positive trend in best-corrected visual acuity (3.3 fewer letters lost, p=0.099). The drug’s safety profile remained consistent with no reports of delayed dark adaptation, chromatopsia, or vasculitis, and most adverse events were mild to moderate. Data from the TEASE-1 Stargardt disease study further supports gildeuretinol’s efficacy, showing a significant 21.6% reduction (p<0.001) in atrophic lesion growth compared to the untreated group. These results suggest gildeuretinol holds promise as a potential treatment for both GA secondary to AMD and Stargardt disease. Further research, including larger and longer-term studies, will be crucial to confirm these findings and fully assess the drug’s long-term efficacy and safety profile. Positive outcomes could lead to a much-needed therapeutic option for these debilitating retinal conditions, significantly impacting the lives of affected patients.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
