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Press Release

Opthea's Phase 1 Data From Wet AMD Clinical Trial Presented at EURETINA Congress 2016

Posted on: 13 Sep 16

MELBOURNE, AUSTRALIA--(Marketwired - Sep 12, 2016) - Opthea Limited ( ASX : OPT ) ( OTCQX : CKDXY ), a developer of novel biologic therapies for the treatment of eye diseases, today announced that data from its Phase 1 clinical trial of OPT-302 was presented at the European Society of Retina Specialists (EURETINA) Congress on Saturday, 10th September 2016, in Copenhagen, Denmark. OPT-302 is Opthea's lead program, a novel VEGF-C/D 'Trap' therapy for wet age-related macular degeneration (wet AMD).

The presentation titled "A first-in-human Phase 1/2a study of the novel VEGF-C/D inhibitor OPT-302 alone and in combination with ranibizumab in patients with wet AMD" was presented by Dr. Pravin Dugel, Managing Partner of Retinal Consultants of Arizona, Clinical Professor at the University of Southern California Eye Institute, Keck School of Medicine, and member of Opthea's Clinical Advisory Board and Clinical Investigator. 

The presentation was part of the "Novelties and Late-Breaking Developments in Retina and Technology" session and provided an overview of the scientific rationale for targeting VEGF-C/-D for the treatment of wet AMD and the recently announced positive data from Opthea's ongoing first-in-human clinical trial of OPT-302 ( ID#: NCT02543229). The encouraging results from the study demonstrate safety and tolerability of OPT-302 administered as a monotherapy and in combination with standard of care Lucentis® and suggest that combined administration of OPT-302 + Lucentis® may lead to improved clinical outcomes over Lucentis® alone.

The EURETINA Congress, held September 8-11th 2016, was attended by over 4500 professionals from the investor, pharmaceutical and clinical ophthalmology community and is the largest gathering of specialist retinal ophthalmologists and associated healthcare professionals in Europe. 

A copy of Dr. Dugel's presentation is available in the "presentations" section of Opthea's website,

About Opthea Limited

Opthea ( ASX : OPT ) is a biologics drug developer focusing on ophthalmic disease therapies. It controls exclusive worldwide rights to a significant intellectual property portfolio around Vascular Endothelial Growth Factor (VEGF)-C, VEGF-D and VEGFR-3. The applications for the VEGF technology, which functions in regulating blood and lymphatic vessel growth, are substantial and broad. Opthea's product development programs are focused on developing OPT-302 (formerly VGX-300, soluble VEGFR-3) for 'back of the eye' disease such as wet age-related macular degeneration (wet AMD).

About Wet AMD

Wet (neovascular) age-related macular degeneration, or wet AMD, is a disease characterised by the loss of vision of the middle of the visual field caused by degeneration of the central portion of the retina (the macula). Abnormal growth of blood vessels below the retina, and the leakage of fluid and protein from the vessels, causes retinal degeneration and leads to severe and rapid loss of vision.

Wet AMD is the leading cause of blindness in the developed world in individuals aged 50 years or older. The prevalence of AMD is increasing annually as the population ages. Without treatment, wet AMD patients often experience a chronic, rapid decline in visual acuity and increase in retinal fluid. Sales of the drug Lucentis® (Roche/Novartis), which targets VEGF-A but not VEGF-C or VEGF-D, were over $US4.5BN in 2015. Sales of EYLEA® (Regeneron/Bayer), which also targets VEGF-A but not VEGF-C/-D first marketed in November 2011 for the treatment of wet AMD, were over $US2.6BN in 2015. Approximately half of the people receiving Lucentis®/EYLEA® are classified as non-responders or 'poor' responders and do not experience a significant gain in vision and/or have persistent retinal vascular leakage. There is great opportunity to improve patient responses by targeting more than one factor involved in disease progression. Existing therapies, such as Lucentis® and EYLEA®, target VEGF-A that promotes blood vessel growth and leakage through its receptor VEGFR-2. VEGF-C can also induce angiogenesis and vessel leakage through the same receptor as well as through an independent pathway. Combined inhibition of VEGF-A and VEGF-C/-D, has the potential to improve patient response by more effective inhibition of the pathways involved in disease progression.

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Editor's Details

Mike Wood

Last updated on: 13/09/2016

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