With Adverum Biotechnologies Inc.’s preliminary safety and efficacy data made public from the ongoing Luna phase II trial testing gene therapy ixoberogene soroparvovec (ixo-vec) in wet age-related macular degeneration (AMD), Wall Street promptly began stacking the results against those of competitors. CEO Laurent Fischer pointed out that ixo-vec boasts the “highest rate of injection-free patients of any study of any program at any dose.”
Korean bioventure Curacle Co. Ltd. reported positive top-line findings from its U.S.-based phase IIa study of CU06-1004, an oral drug for diabetic macular edema, spurring plans for a bigger phase IIb study in the second half of 2024.
Oxurion NV, which had spent much of 2023 scraping together funding in hopes of a positive readout for its bicyclic peptide, THR-149, in diabetic macular edema (DME), now faces a bankruptcy filing after the drug failed to best established anti-VEGF therapy aflibercept (Regeneron Pharmaceuticals Inc.) in improving vision in part B of the phase II Kalahari study.
Eyebiotech Ltd. doubled the size of its series A round, raising $130 million to advance a pair of assets, with a phase Ib/IIa trial dubbed Amarone underway testing the drug called Restoret in patients with diabetic macular edema and neovascular, or wet, age-related macular degeneration.
On the heels of the U.S. FDA clearance for Veopoz (pozelimab-bbfg) from Regeneron Pharmaceuticals Inc. to treat Chaple disease, the regulatory rollercoaster ride for the firm’s bid with higher-dose Eylea (aflibercept) ended with a green light for that compound as well. Eylea HD is indicated for wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.
With its sights firmly set on being the first company to bring a topical diabetic macular edema (DME) treatment to market, Oculis Holding AG moved a step closer to this potentially game-changing reality as its dexamethasone formulation, OCS-01, turned up a statistically significant improvement in mean BCVA – a measure of visual acuity – at the three-month mark in the phase III DIAMOND trial.
Therini Bio Inc. has closed a US$36 million series A financing round that will support its work on developing fibrin-targeted therapies for diseases driven by chronic inflammation, including Alzheimer’s disease, multiple sclerosis and retinal diseases such as diabetic macular edema.
