BioAge Labs announced that it has dosed the first participant in QUELL-DME, a randomized, controlled Phase 2 trial evaluating once-daily oral BGE-102 in adults with diabetic macular edema.
The approximately 180-participant, three-arm study will evaluate BGE-102 both as monotherapy and as an add-on to standard-of-care anti-VEGF intravitreal therapy, with change in best-corrected visual acuity at week 12 as the primary endpoint and exploratory measures of retinal parameters and intraocular and plasma biomarkers.
Arms comprise intravitreal anti-VEGF plus placebo, intravitreal anti-VEGF plus BGE-102 90 mg once daily, and sham intravitreal injection plus BGE-102 90 mg once daily, with 12 weeks of dosing and a four-week follow-up.
Topline results are anticipated in the second half of 2027. The company claims BGE-102 is a structurally novel, orally available, brain-penetrant NLRP3 inhibitor and that trial findings will inform development in other NLRP3-driven retinal diseases, including geographic atrophy.
