Allegro Ophthalmics Announces Presentation Of New Data At Macula 2012 On Novel Class Of Vascular Eye Disease Therapy

SAN JUAN CAPISTRANO, CA and NEW YORK, NY — January 20, 2011 —Allegro Ophthalmics, LLC, announced that Barry Kuppermann, MD, PhD, will present expanded data on the Integrin Peptide Therapy phase 1 human study for the treatment of diabetic macular edema (DME), as well as a recently completed additional animal study conducted by Peter Campochiaro, MD, at The Wilmer Eye Institute at Johns Hopkins.

The presentation, “Integrin Inhibition for the Treatment of Diabetic Macular Edema,” will take place on Saturday, January 21, as part of a presentation panel from 10:45-11:45 am at the Farkas Auditorium, New York University School of Medicine in New York. In addition to presenting data demonstrating that more than 50% of patients in the phase 1 Study experienced three to five lines of improvement in best corrected visual acuity (BCVA) with corresponding improvements in OCT central macular thickness (CMT), Dr. Kuppermann will present expanded data showing that the Phase 1 study nonresponders did not experience any material loss in BCVA or increase in CMT during the study. Additionally, several patients entered the study with early proliferative diabetic retinopathy (PDR), and nearly all of these patients experienced either a regression or no progression in their disease during the study.

This open label, single dose study focused on determining the safety and initial efficacy of integrin peptide therapy. All enrolled patients suffered from advanced stage DME with or without early PDR, possessing a visual acuity of 20/100 or worse. In addition to demonstrating a three to five line improvement in BCVA for the more than 50% of trial patients, the treatment benefits lasted until the end of the study (i.e., 90 days off treatment) — significantly longer than current standard of care.

In addition, Dr. Kuppermann will be presenting new data regarding the recently completed study by Peter Campochiaro using ALG-1001 with an ischemic retinopathy treated mouse model for pre-retinal neovascularization. This study proved that three different doses of ALG-1001 exhibited statistical significance with respect to causing significant inhibition of neovascularization.

“This is exciting progress for Allegro and ALG-1001,” said Dr. Kuppermann, Professor & Chief of The Retina Service at University of California, Irvine and member, Allegro Ophthalmics’ scientific advisory board. “This is an entirely new platform for treating patients with vascular eye diseases and we are getting study results that are showing it has great potential.”

Integrin peptide therapy is an emerging new class of treatment for vascular eye diseases. By utilizing a small molecule discovered by Allegro Ophthalmics’ founders in collaboration with CalTech, ALG-1001 works earlier in the cascade than current anti-VEGF treatments by binding to multiple integrin-receptor sites and affecting multiple angiogenic pathways.

“Integrin peptide therapy is an emerging new class of treatment for vascular eye diseases based on our discovery of ALG-1001, an anti-integrin oligopeptide. Introducing a new class of treatment that works upstream with a different mechanism of action from current anti-VEGF treatment can provide additional options and benefits to patients,” said Vicken Karageozian, M.D., Co-Founder and Chief Technology Officer, Allegro Ophthalmics.

Integrin peptide therapy works by delivering a small, anti-integrin oligopeptide with a unique MOA that shuts off VEGF production directly at its source, blocking activation of VEGF receptors, inhibiting tyrosine kinase, and causing a PVD and vitreous liquefaction to increase VEGF turnover.

By contrast, therapies in the current standard of care for patients suffering from neovascular eye diseases (such as DME, Wet Age-Related Macular Degeneration and Diabetic Retinopathy) bind and inhibit vascular endothelial growth factors (VEGFs) that cause bleeding and fluid leakage into the eye.

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