New combination therapy shows promise in age-related macular degeneration

Pharma News: An Australian clinical stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, announced promising results for its Phase 2b combination study in wet age-related macular degeneration (AMD).

Opthea’s Phase 2b trial of treatment-naïve patients with wet AMD demonstrated that monthly intravitreal administration of OPT-302 plus Novartis’ Lucentis (ranibizumab) combination therapy met the primary endpoint of a superior gain in visual acuity at 24 weeks, compared to Lucentis monotherapy.

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.

Professor Tim Jackson, lead author and Consultant Ophthalmic Surgeon at King’s College London, commented “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 3 studies in wet AMD.”

Traveling to an ophthalmologist’s practice and getting an injection directly into the eye is an onerous routine and many patients struggle with compliance.

Roche’s Vabysmo (faricimab), which was in development for more than a decade, inhibits both the angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) pathways. Eylea, on the other hand, targets just VEGF-A.

Vabysmo secured PBS listing from 1st January 2023 for the treatment of wet AMD and diabetic macular oedema (DMO). With the potential to require fewer injections over time, Vabysmo represents an important step forward for people with vision-threatening retinal conditions.

Dr Megan Baldwin, CEO and Managing Director of Opthea, 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 this study.

“The robust results of this large Phase 2b trial have informed and provided the foundation for our ongoing Phase 3 registrational program of OPT-302 in combination with anti-VEGF-A therapy for the treatment of wet AMD.”

Opthea is currently conducting two global Phase 3 studies; ShORe (2 mg OPT-302 + 0.5 mg Lucentis), and COAST (2 mg OPT-302 + 2 mg Bayer’s Eylea (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.

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