Denali Therapeutics Inc. has patented new NAD(+) hydrolase SARM1 (SAMD2; MyD88-5) inhibitors reported to be useful for the treatment of glaucoma, spinal cord Injury, leukoencephalopathy, mitochondrial disease, multiple sclerosis, Niemann-Pick disease, spinal muscular atrophy and stroke, among others.
Seinda Pharmaceutical Corp. has disclosed peptides reported to be useful for the treatment of corneal epithelial defect, corneal neovascularization and dry eye.
Iveric Bio Inc.’s regulatory win Aug. 4 drew attention to the already hot eye-disease space, where intriguing new developments include the possibility of an oral therapy for Stargardt disease. Belite Bio Inc. in late July finished enrollment of a phase III study with once daily tinlarebant, a retinol binding protein 4 antagonist for Stargardt’s. Data from 90 adolescent subjects in the study called Dragon are due in mid-2024.
Galimedix Therapeutics Inc. plans to move its lead compound, GAL-101, into a phase IIa proof-of-concept trial next year, in order to test an intriguing hypothesis associated with certain retinal degeneration conditions. GAL-101 selectively binds misfolded amyloid beta species, and the company believes that this mechanism may benefit patients with the dry form of age-related macular degeneration or with glaucoma.
In its second big pharma deal to date, Shape Therapeutics Inc. drew Otsuka Pharmaceutical Co. Ltd. to the table in a potential $1.5 billion-plus collaboration initially aimed at developing gene therapies for ocular diseases. The multitarget agreement, which includes options for additional targets and tissue types, will combine Shape’s AI-driven adeno-associated virus (AAV) platform and Otsuka’s expertise in ophthalmology to develop intravitreally delivered AAV therapies.
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.
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