Age-Related Macular Degeneration (AMD)
Nov. 28, 2012 Eylea approved in Europe
One of Eylea’s key selling points will be its less frequent dosing. Bayer’s drug is given every two months after three initial monthly injections, compared to monthly Lucentis injections.
Read more: Eye drug Eylea approved in Europe
iSONEP ™ and ASONEP(TM) are different formulations of a first-in-class therapeutic antibody developed by Lpath's ImmuneY2(TM) drug-discovery engine. Antibodies developed via this discovery engine are designed to target bioactive signaling lipids, such as S1P, that are involved in the proliferation and spread of cancer, age-related macular degeneration (AMD), inflammatory and auto-immune disorders, and many other diseases.
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In this human proof-of-concept trial, Lpath plans to dose 32 subjects -- 16 at a lower dose and 16 at a higher dose -- that have PED secondary to wet age-related macular degeneration (wet AMD) or polypoidal choroidal vasculopathy (PCV).
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Lpath intends to start another iSONEP trial in June of this year, a Phase 2 human-proof-of-concept trial to study the efficacy and safety of iSONEP in wet AMD patients that do not have PED.
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In this Phase 1b/2a trial, Lpath plans to dose 32 subjects that have retinal pigment epithelium detachment (PED) that is secondary to wet age-related macular degeneration (wet AMD) or polypoidal choroidal vasculopathy (PCV).
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Lpath will soon initiate two iSONEP Phase II trials: The PEDigree Study will evaluate the safety and efficacy of iSONEP in patients with RPE Detachment (PED), for which there is no approved drug, and the Nexus Study will evaluate the safety and efficacy in wet-AMD patients without PED.
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ISONEP is currently beginning Phase 1b/2a trials for the treatment of wet-form AMD. With wet macular degeneration, new blood vessels grow beneath the retina and leak blood and fluid.
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Lpath Grants Pfizer Exclusive Option for Worldwide License for iSONEP
iSONEP is scheduled to begin a Phase 1b clinical trial in wet AMD patients with Pigment Epithelial Detachment (PED), a complication of wet AMD, in the first quarter of 2011 and a Phase 2a clinical trial in wet AMD patients in the second quarter of 2011.
Lpath, Inc. reported positive results of its single-dose Phase 1 clinical trial of iSONEP, an anti-sphingosine-1-phosphate monoclonal antibody, in neovascular age-related macular degeneration (AMD) patients.
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Since Philip J. Rosenfeld, MD, PhD, of Bascom Palmer Eye Center in Miami, began using bevacizumab in patients with AMD - if not before then - the treatment of neovascular AMD and resolution of choroidal neovascularization has been linked to the development of treatments designed to prevent metastasis of cancer.
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