U.S. Phase 2 Study Published in OSLI Retina Highlights the Safety and Efficacy of Risuteganib in Patients with Dry Age-Related Macular Degeneration

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SAN JUAN CAPISTRANO, CA — August 3, 2021 — 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.

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.

Vicken Karageozian, M.D., President and CEO of Allegro Ophthalmics, said, “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. 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, M.D., 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.”

The paper can be accessed from OSLI Retina’s website at https://journals.healio.com/journal/oslir. For more information about this trial, visit www.ClinicalTrials.gov using the number NCT03626636.

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, may simultaneously act on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases, such as dry AMD. A U.S. Phase 2a study with risuteganib in less advanced dry AMD met its primary endpoint of vision recovery. Expanding its integrin-regulating portfolio, Allegro has developed ALG-1007 for topical use in dry eye disease. ALG-1007 demonstrated promising results in an ex-U.S. proof-of-concept study in humans, and is currently being evaluated in a second and larger ex-U.S. Phase 2 study. For more information, visit www.allegroeye.com.

Risuteganib (Luminate®) and ALG-1007 are investigational drugs and are not approved for commercial sale.

Luminate® is a registered trademark of Allegro Ophthalmics, LLC.

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