US Phase 2 Study Published in OSLI Retina Highlights the Safety and Efficacy of Risuteganib in Patients with Dry AMD
Allegro Ophthalmics announced that the results of the company’s US phase 2a risuteganib non-exudative age-related macular degeneration (dry AMD) study are published in Ophthalmic Surgery, Lasers, and Imaging (OSLI) Retina. Entitled “Safety and Efficacy of Intravitreal Risuteganib for Non-Exudative AMD: A Multicenter, Phase 2a, Randomized, Clinical Trial,” this paper describes the treatment effect of risuteganib 1.0 mg in patients with intermediate dry AMD.
The primary endpoint—the proportion of subjects with ≥ 8 letters ETDRS BCVA gain from baseline—was met by 48% of patients in the risuteganib group at week 28 and 7% of patients in the sham group at week 12 (P=0.013). Risuteganib was found to be safe with no reported drug related serious adverse events.
Risuteganib is a small peptide oxidative stress stabilizer that has been shown to protect human RPE cells against oxidative stress-associated cellular dysfunction. These clinical data suggest that risuteganib can reverse vision loss and restore functional vision in patients with intermediate dry AMD with treatment at a 12-week interval.
“To our knowledge, this is the first study to use a functional endpoint and demonstrate reversal of vision loss in a study population with intermediate dry AMD, a sight-threatening disease for which there is currently no available therapeutic treatment,” Vicken Karageozian, MD, President and CEO of Allegro Ophthalmics, said in a company news release. “These clinical findings in dry AMD complement our extensive preclinical findings and earlier clinical studies that suggested risuteganib could restore visual function.”
David S. Boyer, MD, Founder, Retina-Vitreous Associates Medical Group and lead author, commented, “Dry AMD patients suffer from progressive vision loss affecting activities of daily living. Having a drug that could restore vision would have tremendous impact on the quality of life of these patients.”