Glaukos Corp. brought home a nice year-end gift for investors with a broad U.S. FDA approval for the Idose TR. Indicated for use in patients with primary open-angle glaucoma or ocular hypertension across the full range of disease severity, the device/drug combo provides continuous release of a prostaglandin analog that reduces intraocular pressure via a titanium device implanted through a corneal incision for up to three years.
The University of Southern California (USC) reported filing a patent for a retinal ganglion cell (RGC) stimulation system in which electrodes may be placed in, around or near sites of optic nerve injury to generate electric fields that can direct the direction of axonal regeneration.
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.
Santen Pharmaceutical Co. Ltd. is selling its North American branded ophthalmic portfolio to Visiox Pharma LLC and Harrow Health Inc. in a move to make its global organization as competitive as possible, Santen told BioWorld.
Santen Pharmaceutical Co. Ltd. is selling its North American branded ophthalmic portfolio to Visiox Pharma LLC and Harrow Health Inc. in a move to make its global organization as competitive as possible, Santen told BioWorld.
Apellis Pharmaceutical Inc.’s shares nosedived by 37% July 17 after the American Society of Retina Specialists wrote to ophthalmologists warning them of the risk of serious intraocular inflammation events in patients following injection of the company’s geographic atrophy drug, Syfovre (pegcetacoplan).
A non-invasive retinal exam may soon enable clinicians to visualize the future for patients at risk of chronic kidney disease (CKD). When combined with an artificial intelligence algorithm, an exam accurately predicted CKD prior to symptom onset in a study published in Digital Medicine.
The U.S FDA 510(k) clearance for Corneat Vision Ltd.’s Everpatch is a “safety stamp” for the product, and the “first step’ in the deployment of Corneat’s synthetic tissue substitute technology, which could displace the use of donor and processed tissue, Almog Aley-Raz, CEO of Corneat, told BioWorld. The Corneat Everpatch, for use in ophthalmic surgeries, is the first non-degradable material that seamlessly embeds itself with surrounding tissue avoiding foreign body response often triggered by implanted devices, Aley-Raz claimed.
Beneficiaries in the U.S. Medicare program have access to several technologies and procedures for treatment of glaucoma, but Medicare administrative contractors (MACs) seem to be looking sideways at some of these offerings. Both Wisconsin Physician Services and Palmetto GBA have floated draft local coverage proposals that deem procedures such as goniotomy and the combination of canaloplasty and trabeculectomy to be investigational, suggesting that claims for these and other services and devices will not be paid by these MACs.
Coave Therapeutics aims to move its lead gene therapy program, CTx-PDE6b, for a form of retinitis pigmentosa (RP) into a pivotal trial in 2025 on the back of a phase I/II study, which uncovered a preliminary efficacy signal in one patient subgroup.