The FDA has accepted Eyenovia Inc.’s new drug application (NDA) for Mydcombi, a fixed combination pupil dilation agent, with a PDUFA date of Oct. 28, 2021.
HONG KONG – Johnson & Johnson Vision (J&J Vision) has received its first global approval from Japan for its Acuvue Theravision with Ketotifen contact lenses. The Japanese Ministry of Health, Labour and Welfare’s green light will help with patients with vision correction, while simultaneously alleviating ocular allergic symptoms for allergic conjunctivitis, while they wear the lenses.
Israeli med-tech startup Forsight Robotics Ltd. has closed a $10 million seed funding round led by Eclipse Ventures and joined by Mithril Capital. The funding will help advance the company’s work on a surgical robotic platform that employs microsurgical robotics, computer visualization and machine learning to automate many of the complex elements of ophthalmic surgery.
PARIS – Less than a year after its formation, Acusurgical SAS, has secured a $7 million series A round to develop its robotic platform for assisting surgeons performing microsurgery procedures in retinal surgery. “Our goal isn’t to replace the surgeon but to increase his surgical capacities. Our mission is to create an augmented surgeon,” Christoph Spuhler, CEO and co-founder of Montpellier, France-based Acusurgical, told BioWorld.
Glaukos Corp. reported 12-month results from the pivotal IDE trial of its Istent Infinite trabecular micro-bypass system, showing substantial reduction in mean diurnal intraocular pressure (IOP) in patients with open-angle glaucoma uncontrolled by prior surgery or medication. The company is targeting U.S. FDA approval of the device for standalone moderate-to-severe glaucoma in late 2021.
Pixium Vision SA and Second Sight Medical Products Inc. have inked a definitive agreement through which the former will become the controlling shareholder of the newly combined company. The transaction also will result in the creation of a new entity that will focus on cortical stimulation through Orion. Second Sight is developing that product, which bypasses the diseased eye and could provide a new form of vision.
Heru Inc., a medical technology company using artificial intelligence (AI) to advance vision diagnostics and augmentation, has completed class I device registration with the U.S. FDA for its cloud-based diagnostic application for visual field exams. Heru’s software works with commercially available augmented reality or virtual reality (AR/VR) headsets to provide a subjective visual field exam, with results immediately available to clinicians through a web portal.
LONDON – Researchers at University College London (UCL) have devised a new eye test they say can predict the likelihood of developing wet age-related macular degeneration (AMD) up to three years before overt symptoms develop. The prognostic test involves injecting a fluorescent dye, via the arm, to tag stressed endothelial cells in the retina.
PARIS – Tilak Healthcare SAS is signing an ophthalmology partnership agreement with Novartis AG from Basel, Switzerland, to expand international distribution of its vision monitoring technology, Odysight.
Eyenovia Inc., a clinical-stage ophthalmic biopharmaceutical firm, has launched a phase III trial of its on-demand treatment for presbyopia, an age-related worsening in near vision. The treatment, called Microline, is a proprietary formulation of pilocarpine delivered via a microdosing dispenser.