By David Hutton
Oral gildeuretinol demonstrated a clinically meaningful reduction in the geographic atrophy lesion growth rate at 24 months, supporting additional clinical development. SAGA topline data has been accepted as a late breaker at the 128th annual meeting of the American Academy of Ophthalmology, being held October 18-21 in Chicago.
Alkeus Pharmaceuticals Inc. announced that the SAGA study of oral gildeuretinol acetate (ALK-001) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) demonstrated a reduction of 0.25 sqmm/year vs. placebo (p=0.07) in the primary endpoint of GA lesion growth rate at 24 months.
According to the company, gildeuretinol demonstrated a statistically significant reduction in the loss of low luminance visual acuity (LLVA) at 24 months (p=0.03). Gildeuretinolshowed a favorable safety profile consistent with other studies of gildeuretinol in Stargardt disease.
The company noted that topline results are scheduled to be presented as a late-breaker at the 128th annual meeting of the American Academy of Ophthalmology (AAO) during Retina Subspecialty Day on Friday, October 18, in Chicago.
Seemi Khan, MD, MPH, MB., chief medical officer of Alkeus Pharmaceuticals, pointed out in a statement that these data indicate a clinically meaningful trend in slowing the growth rate of GA lesions.1
“The SAGA data represent the first clinical demonstration that slowing vitamin A dimerization could be beneficial in the treatment of GA secondary to AMD. Results from SAGA build upon the positive data from TEASE-1, a study of gildeuretinol in Stargardt disease,” he said in the statement. “We look forward to discussing these results with the U.S. Food and Drug Administration to determine the optimal path forward. We extend our gratitude to the patients, investigators, and trial sites for their participation in this study.”…
Read more: https://www.ophthalmologytimes.com/view/alkeus-pharmaceuticals-announces-results-from-the-saga-study-of-oral-gildeuretinol-in-patients-with-ga
Source: Ophthalmology Times