Study Meets Primary Efficacy Endpoint with 65% of Patients Treated with Luminate® Achieving VMT or VMA Release
SAN JUAN CAPISTRANO, CA, USA I July 13, 2015 I Allegro Ophthalmics, LLC, today announced that the Phase 2 clinical trial of Luminate® (ALG-1001) in patients with vitreomacular traction (VMT) or vitreomacular adhesion (VMA) met its primary endpoint. In the phase 2, prospective, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of intravitreal injections of Luminate in 106 study subjects, 65 percent of eyes treated with the 3.2 mg dose of Luminate achieved release of VMT or VMA by Day 90 (end of study), compared to 9.7 percent of those in the placebo control group (p=0.0129).
The study, which included three Luminate groups (2.0 mg, 2.5 mg, or 3.2 mg) and a balanced salt solution (BSS) placebo group, also found that Luminate was well-tolerated with no drug toxicity or intraocular inflammation noted with repeated intravitreal injections. These safety results are consistent with previously conducted Luminate studies on human subjects where there were no rod or cone photoreceptor dysfunction on full-field electroretinogram testing, no afferent pupillary defects, and no evidence of retinal tears or detachments.
“These findings appear to be very promising,” says Michael Tolentino, M.D., Associate Professor Ophthalmology at the University of Central Florida, Director of Research for the Center for Retina and Macular Disease, and Clinical Investigator of this Phase 2 VMT study. “It is a very positive outcome to have 65 percent of eyes treated with the 3.2 mg dose of Luminate achieve VMT/VMA release by Day 90. These statistically significant findings, as assessed by the Duke Reading Center, coupled with the fact that Luminate has been shown to be well-tolerated, makes me optimistic that Luminate will provide meaningful clinical benefit to patients with VMT or VMA.”
“These positive results continue to affirm the safety and efficacy of Luminate,” says Vicken Karageozian, M.D., Chief Technical Officer, Allegro Ophthalmics. “The vitreolytic properties confirmed in this study and the anti-angiogenic properties demonstrated in earlier DME and neovascular AMD studies continue to validate our clinical development approach of advancing Luminate across multiple vitreoretinal indications.”
Luminate, a first-in-class integrin peptide therapy, treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation and in the construction of new and aberrant blood vessels. By utilizing two mechanisms of action (vitreolysis and anti-angiogenesis), Luminate has been shown in clinical studies to date to effectively regress and inhibit new blood vessel formation, as well as reduce vascular leakage to maintain and restore vision. Currently in Phase 2 clinical trials for multiple indications, including diabetic macular edema (DME) and non-proliferative diabetic retinopathy (NPDR), Luminate is an investigational drug not approved by the FDA for commercial sale in the U.S. Allegro maintains commercial rights to Luminate in all territories outside of Japan, Korea and China.
About Allegro Ophthalmics, LLC
With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC, is working to establish integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases. Allegro’s lead investigational drug, Luminate, is currently in Phase 2 studies and has the potential to significantly reduce the current burden of intravitreal injections and to be a viable option for patients with diabetic macular edema, diabetic retinopathy, wet age-related macular degeneration, and vitreomacular traction. By quickly, safely and cost-effectively bringing to market new and improved treatment options for leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision. For more information, visit www.allegroeye.com.
SOURCE: Allegro Ophthalmics
Post Views: 23
Study Meets Primary Efficacy Endpoint with 65% of Patients Treated with Luminate® Achieving VMT or VMA Release
SAN JUAN CAPISTRANO, CA, USA I July 13, 2015 I Allegro Ophthalmics, LLC, today announced that the Phase 2 clinical trial of Luminate® (ALG-1001) in patients with vitreomacular traction (VMT) or vitreomacular adhesion (VMA) met its primary endpoint. In the phase 2, prospective, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of intravitreal injections of Luminate in 106 study subjects, 65 percent of eyes treated with the 3.2 mg dose of Luminate achieved release of VMT or VMA by Day 90 (end of study), compared to 9.7 percent of those in the placebo control group (p=0.0129).
The study, which included three Luminate groups (2.0 mg, 2.5 mg, or 3.2 mg) and a balanced salt solution (BSS) placebo group, also found that Luminate was well-tolerated with no drug toxicity or intraocular inflammation noted with repeated intravitreal injections. These safety results are consistent with previously conducted Luminate studies on human subjects where there were no rod or cone photoreceptor dysfunction on full-field electroretinogram testing, no afferent pupillary defects, and no evidence of retinal tears or detachments.
“These findings appear to be very promising,” says Michael Tolentino, M.D., Associate Professor Ophthalmology at the University of Central Florida, Director of Research for the Center for Retina and Macular Disease, and Clinical Investigator of this Phase 2 VMT study. “It is a very positive outcome to have 65 percent of eyes treated with the 3.2 mg dose of Luminate achieve VMT/VMA release by Day 90. These statistically significant findings, as assessed by the Duke Reading Center, coupled with the fact that Luminate has been shown to be well-tolerated, makes me optimistic that Luminate will provide meaningful clinical benefit to patients with VMT or VMA.”
“These positive results continue to affirm the safety and efficacy of Luminate,” says Vicken Karageozian, M.D., Chief Technical Officer, Allegro Ophthalmics. “The vitreolytic properties confirmed in this study and the anti-angiogenic properties demonstrated in earlier DME and neovascular AMD studies continue to validate our clinical development approach of advancing Luminate across multiple vitreoretinal indications.”
Luminate, a first-in-class integrin peptide therapy, treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation and in the construction of new and aberrant blood vessels. By utilizing two mechanisms of action (vitreolysis and anti-angiogenesis), Luminate has been shown in clinical studies to date to effectively regress and inhibit new blood vessel formation, as well as reduce vascular leakage to maintain and restore vision. Currently in Phase 2 clinical trials for multiple indications, including diabetic macular edema (DME) and non-proliferative diabetic retinopathy (NPDR), Luminate is an investigational drug not approved by the FDA for commercial sale in the U.S. Allegro maintains commercial rights to Luminate in all territories outside of Japan, Korea and China.
About Allegro Ophthalmics, LLC
With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC, is working to establish integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases. Allegro’s lead investigational drug, Luminate, is currently in Phase 2 studies and has the potential to significantly reduce the current burden of intravitreal injections and to be a viable option for patients with diabetic macular edema, diabetic retinopathy, wet age-related macular degeneration, and vitreomacular traction. By quickly, safely and cost-effectively bringing to market new and improved treatment options for leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision. For more information, visit www.allegroeye.com.
SOURCE: Allegro Ophthalmics
Post Views: 23
