The U.S. FDA inked a Dec. 20, 2022, warning letter to Righteye LLC that handed the company a list of quality system issues in dire need of redress, but the agency was more concerned about off-label promotion of the Righteye vision system as a method for evaluating the patient’s ocular tremors as a sign of Parkinson’s disease.
Researchers from Curacle Co. Ltd. and Yonsei University have published preclinical data for the endothelial dysfunction blocker CU06-1004 from studies assessing it in models of retinal vascular disease.
Ocuphire Pharma Inc. is marching ahead despite falling short of the primary endpoint in top-line data from the Zeta-1 phase II study testing oral APX-3330 in diabetic retinopathy (DR). The trial did not achieve its goal with regard to the percentage of patients with a ≥2-step improvement in Diabetic Retinopathy Severity Score at week 24 in the study eye. Ocuphire plans to schedule an end-of-phase II meeting with the U.S. FDA to review the results.
Exegenesis Bio (Hangzhou Exegenesis Biotechnology Co. Ltd.) has received FDA clearance of its IND application for EXG-102-031, a recombinant adeno-associated virus (rAAV)-based gene therapy that is being studied for the treatment of neovascular age-related macular degeneration (AMD).
National Institute of Pharmaceutical R&D Co. Ltd. has discovered compounds with ability to capture reactive carbonyl species reported to be useful for the treatment of eye disorders, among others.
Traumatic optic neuropathy (TON) is a serious complication combining craniocerebral, orbital and facial injuries. While there is currently no reliable animal model of this condition, it has been previously demonstrated that TON can cause the loss of retinal ganglion cells (RGC). In the current study, researchers from Shanghai Jiaotong University developed a novel mouse model of distal TON, with the aim of assessing the cascade reactions of RGCs in this disease.
The eyes certainly have it. There are plenty of ocular gene therapies being studied in a crowded field and now there is a new one as Perceive Biotherapeutics Inc. has closed on a $78 million series B financing.
Cancer Focus Fund LP is investing US$5 million in funding to support ISA Pharmaceuticals BV's ISA-103 in a first-in-human study for the treatment of uveal melanoma.
Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss in persons over the age of 50. While poorly understood, AMD pathogenesis begins with structural disorganization of the outer-blood-retina-barrier (oBRB), containing retinal pigment epithelium (RPE) and associated Bruch’s membrane.
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