A single intravitreal dose of Allgenesis Biotherapeutics’s AG-73305, a protein designed to block VEGF and integrin pathways, showed improvement of best-corrected visual acuity (BCVA) and reduction of central subfield thickness (CST) lasting up to 24 weeks in patients with diabetic macular edema (DME). The effect is greater than what is expected from an anti-VEGF monotherapy, researchers reported at the Association for Research in Vision and Ophthalmology (ARVO) meeting in May.
In a phase 2a multicenter, open-label, single ascending dose cohort study of 25 patients (ClinicalTrials.gov Identifier: NCT05301751), AG-73305 was found to be safe and well-tolerated at 4 doses (0.5 mg, 1 mg, 2 mg, and 4 mg) administered by intravitreal injection. Over 50% of patients (n=14) achieved a maximum BCVA letter gain of 10 to 23 ETDRS letters after a single injection, with a mean CST reduction of -100 µm 4 weeks after the injection.
According to the company, AG-73305 is a humanized, bispecific Fc-fusion protein designed to simultaneously block VEGFs and various key integrin receptors. In addition to DME, it could one day be an effective treatment for neovascular age-related macular degeneration, retinal vein occlusion, and other retinal diseases, Allgenesis said in a press release.