SAN JUAN CAPISTRANO, Calif., April 12, 2023 /PRNewswire/ -- Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel mitochondrial stabilizers for the treatment of ocular diseases, today announced that the Company has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design of its Phase 2b/3 clinical trial of risuteganib (Luminate®) for the treatment of intermediate, non-exudative age-related macular degeneration (dry AMD). Finalization of this assessment indicates that the FDA agrees that critical elements of the overall protocol design (e.g., entry criteria, dose selection, endpoints, and planned analyses) are adequate and acceptable for a study intended to support a future marketing application.
SAN JUAN CAPISTRANO, Calif., Feb. 10, 2023 /PRNewswire/ -- Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel oxidative stress stabilizers for the treatment of ocular diseases, today announced the presentation of key data supporting dry AMD pipeline candidates, including the company's risuteganib (Luminate®), this morning at Bascom Palmer Eye Institute's 20th annual Angiogenesis, Exudation and Degeneration meeting, being held virtually February 10-11, 2023.1
Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel oxidative stress stabilizers for the treatment of ocular diseases, today announced that the results of the company’s U.S. 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.
Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel integrin-regulating therapies for the treatment of ocular diseases, today announced that William J. Link, PhD, has been appointed chairman by the company’s board of directors and that Stephanie Yee was named vice president of finance.