After hitting the safety and efficacy endpoints in a pivotal study of wet age-related macular degeneration (AMD), Outlook Therapeutics Inc.’s CEO said he had not expected to receive a complete response letter (CRL) from the U.S. FDA. The BLA for ONS-5010 (bevacizumab-vikg) now is on hold, the company said, because the agency said chemistry, manufacturing, and controls management problems were getting in the way, along with “open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.”
A nonsteroidal eye drop formulation of dazdotuftide, TRS-01 missed its late-stage primary endpoint for controlling inflammation in uveitis, but developer Tarsier Pharma Ltd. said post-hoc analysis showing a boosted benefit-risk profile over steroids may be a ray of hope.
Opthea Ltd. plans to raise AU$80 million (US$51.2 million) via a AU$10 million private placement and a AU$70 million entitlement offer to continue its pivotal phase III trials in wet age-related macular degeneration (wet AMD) for lead candidate OPT-302.
Merck Sharp & Dohme Corp. has synthesized plasma kallikrein (KLKB1) inhibitors reported to be useful for the treatment of hereditary angioedema, diabetic macular edema, retinal vein occlusion, diabetic retinopathy, wet macular degeneration (exudative) and uveitis.
Researchers from Nanjing Medical University have published data from a study that aimed to assess the potential of targeting fascin homologue 1 (FSCN1) as novel therapeutic strategy for the treatment of ocular neovascularization.
A nonsteroidal eye drop formulation of dazdotuftide, TRS-01 missed its late-stage primary endpoint for controlling inflammation in uveitis, but developer Tarsier Pharma Ltd. said post-hoc analysis showing a boosted benefit-risk profile over steroids may be a ray of hope.
Opthea Ltd. plans to raise AU$80 million (US$51.2 million) via a AU$10 million private placement and a AU$70 million entitlement offer to continue its pivotal phase III trials in wet age-related macular degeneration (wet AMD) for lead candidate OPT-302.
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.
Novartis AG has identified spirocyclic piperidinyl derivatives acting as complement factor B (CFB) inhibitors reported to be useful for the treatment of age-related macular degeneration (AMD), diabetic retinopathy and eye disorders.
Impact Biotech Ltd. has entered into an agreement with Maastricht University to collaborate on research focused on eye treatment to arrest the progression of pathological myopia, also known as myopic macular degeneration. The project will use Impact's padeliporfin vascular targeted photodynamic (VTP) therapy platform.