Clinical stage biopharmaceutical company Opthea (ASX:OPT) reports its phase 2b study results of OPT-302, which is an anti-VEGF-C/-D ‘trap’ agent administered in combination with Lucentis for the treatment of wet age-related macular degeneration (AMD) has been published online in Ophthalmology, the journal of the American Academy of Ophthalmology.
The company says the prospective, randomised, controlled phase 2b trial of 366 treatment-naïve patients with wet AMD was conducted at 109 clinical sites across the US, Europe and Israel, and demonstrated that monthly intravitreal administration of 2mg OPT-302 with ranibizumab standard of care, met with the pre-specified primary efficacy endpoint of a statistically superior gain in visual acuity at 24 weeks, compared to ranibizumab alone.
In addition, secondary outcomes were positive for the OPT-302 combination therapy including more participants with gains in vision of 10 or more letters, improved anatomy of reduction in swelling and vascular leakage, with a favourable safety profile.
“The robust results of this large phase 2b trial have informed and provided the foundation for our ongoing phase three registrational program of OPT-301″
Commenting on the trial, Opthea Chief Executive Officer (CEO) and Managing Director Megan Baldwin said: “We are gratified that these important clinical findings from the phase 2b trial have been published in Ophthalmology, an internationally recognised peer-reviewed journal and we also wish to thank the patients, investigators and their staff for participating and their efforts in ensuring the success of the study.
The robust results of this large phase 2b trial have informed and provided the foundation for our ongoing phase three registrational program of OPT-301 in combination with anti-VEGF-A therapy for the treatment of wet AMD.”
Also commenting on the article, Lead Author and Consultant Ophthalmic Surgeon at King’s College London Professor Tim Jackson says: “Recently, a focus in wet AMD has been on emerging approaches to extend dosing intervals, which is important, but patient surveys indicate that they rank their main goal as achieving better vision over durability.
The promising results of this phase 2b trial show that OPT-302 combination therapy can deliver vision that is significantly superior to anti-VEGF-A monotherapy, and so we look forward to the results of the ongoing phase three studies in wet AMD.”
Opthea reports the US Food and Drug Administration (FDA) granted OPT-302 Fast Track Designation for the treatment of wet AMD, which facilitates the development and expedites the review of investigation therapies to treat serious conditions and fill an unmet medical need.
Opthea is currently conducting 2 global confirmatory phase three studies, ShORe (2mg OPT-302 plus 0.5mg ranibizumab), and COAST (2mg OPT-302 plus 2mg aflibercept).
The primary endpoint for both studies is superiority in visual acuity gains at 12 months for the combination therapy compared with standard-of-care monotherapy.
Opthea is a biopharmaceutical company developing novel therapies to address unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet-age related macular degeneration, and diabetic macular edema (DME).