SAN JUAN CAPISTRANO, Calif.--(BUSINESS WIRE)--Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel therapies that regulate select integrin functions for the treatment of ocular diseases, today announced that the results of its U.S. Phase 2 study evaluating risuteganib (Luminate®) for the treatment of intermediate nonexudative age-related macular degeneration (dry AMD) will be presented during the 19th European Society of Retina Specialists (EURETINA) Congress that is being held September 5-8 in Paris, France and at The Retina Society 2019 Annual Meeting, which is being held September 11-15 in London, UK.
In June, Allegro announced topline results of the risuteganib Phase 2 intermediate dry AMD clinical trial, which met its primary endpoint with 48 percent of patients in the risuteganib arm at week 28 gaining ≥ 8 letters in visual acuity from baseline, compared to 7 percent 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 (SAEs). In addition to complete best corrected visual acuity (BCVA) data, secondary outcomes for several patient cases will be presented at EURETINA and The Retina Society meeting.
Today, Allegro also announced that the results of its ALG-1007 ex-U.S. proof-of-concept clinical trial for the treatment of dry eye disease (DED) will be presented during the 37th Congress of the European Society of Cataract and Refractive Surgeons (ESCRS), which is being held September 14-18 in Paris, France. ALG-1007, a topical drop, is the company’s second exploratory integrin-regulating drug candidate. In May, Allegro announced that the ex-U.S. proof-of-concept clinical trial concluded that ALG-1007 was well-tolerated and demonstrated a dose-response with improvement of the signs and symptoms of DED as early as two weeks.
“Allegro is excited to present for the very first time the results of our risuteganib Phase 2 intermediate dry AMD trial as well as those of our ALG-1007 ex-US proof-of-concept DED study to the European ophthalmic community,” said Vicken Karageozian, MD, president and CEO, Allegro Ophthalmics, LLC. “It is encouraging to see such visual acuity gains in patients with dry AMD, a sight-threatening disease for which there is currently no available treatment. In addition, the early positive results of the ALG-1007 proof-of-concept study for dry eye disease, which impacts millions of people across the globe, appear promising.”
The scientific presentations are scheduled as follows:
Sunday, September 8: 9:30-9:36 AM
EURETINA, Palais des Congrès, Paris, France (Amphithéâtre Havane)
Safety and Efficacy of Risuteganib in Non Exudative Age-Related Macular Degeneration: Primary Results from a Phase 2 Study
Peter K. Kaiser, M.D.
Thursday, September 12: 2:44-2:50 PM
The Retina Society 2019 Annual Meeting, The Landmark London, London, UK (Grand Ballroom)
Safety and Efficacy of Risuteganib in Intermediate Non-exudative (Dry) Age-Related Macular Degeneration (AMD): Primary Results from a Phase 2 Study
David S. Boyer, M.D.
Monday, September 16: 9:48-9:54 AM
ESCRS, Paris Expo, Porte de Versailles, Paris, France (Free Paper Forum: Podium 2)
Safety and Efficacy of a Novel Integrin Inhibitor ALG-1007 Topical Ophthalmic Solution for the Treatment of Dry Eye Disease
Eric Donnenfeld, M.D.
About Allegro Ophthalmics, LLC
Allegro Ophthalmics, LLC is a privately held biopharmaceutical company focused on the development of novel integrin-regulating therapies for the treatment of ocular diseases. Pre-clinical data suggest that risuteganib (Luminate®), Allegro’s lead investigational compound in retina, simultaneously acts on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases such as intermediate dry AMD and diabetic macular edema (DME). Risuteganib recently successfully completed a U.S. Phase 2 intermediate dry AMD study and also successfully completed two Phase 2 DME studies. Expanding its integrin-regulating portfolio, Allegro has developed ALG-1007, an integrin-regulating drug candidate for topical use in dry eye disease. ALG-1007 has successfully completed an ex-U.S. proof-of-concept study in humans, and is currently being evaluated in a larger ex-U.S. Phase 2 study. For more information, visit www.allegroeye.com.
Luminate® is a registered trademark of Allegro Ophthalmics, LLC.