Gil Roth10.09.13
Allegro Ophthalmics has received FDA approval to begin two Phase II clinical studies of ALG-1001, an Integrin Peptide Therapy. The trials will be conducted in patients with wet age-related macular degeneration (wet AMD) and in patients with symptomatic vitreomacular traction (VMT).
These Phase II studies will be the fifth and sixth studies of ALG-1001. The company has completed two Phase I studies, monotherapy studies in each of diabetic macular edema (DME) and wet AMD. Additionally, two Phase Ib/IIa studies are in progress. To date, all data from human studies, as well as studies in animals, show Integrin Peptide Therapy to be safe, well-tolerated and efficacious, including the fact that the benefit of monotherapy is holding at least three months off-treatment in both wet AMD and DME patients.
These Phase II studies will be the fifth and sixth studies of ALG-1001. The company has completed two Phase I studies, monotherapy studies in each of diabetic macular edema (DME) and wet AMD. Additionally, two Phase Ib/IIa studies are in progress. To date, all data from human studies, as well as studies in animals, show Integrin Peptide Therapy to be safe, well-tolerated and efficacious, including the fact that the benefit of monotherapy is holding at least three months off-treatment in both wet AMD and DME patients.