Alkeus Pharmaceuticals reports promising results for oral gildeuretinol in treating geographic atrophy
Alkeus Pharmaceuticals has announced encouraging findings from the SAGA study, evaluating oral gildeuretinol (ALK-001) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Data presented at the AAO 2024 conference revealed significant benefits in both lesion reduction and visual function.
Patients treated with gildeuretinol experienced a 15.3% reduction in GA lesion growth from 6 to 24 months compared to placebo (P = 0.047). A key secondary outcome showed that the therapy improved low luminance visual acuity (LLVA), with fewer letters lost over 24 months (P = 0.031). Although the primary endpoint—a 13.4% reduction in lesion growth from baseline to 24 months—was not statistically significant (P = 0.075), the results still demonstrated a clinically meaningful trend.
Gildeuretinol also displayed a favorable safety profile, with only 11% of treated patients developing choroidal neovascularization (CNV) or wet AMD, compared to 44% in the placebo group.
“This is the first oral therapy to show functional improvements in low-light vision, addressing a significant unmet need,” said Dr. Alexander Melamud, principal investigator in the study.
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