IDE Group recently unveiled OKO, its new ophthalmic auto-injector for improving drug delivery precision and efficiency. The company says OKO addresses critical unmet needs in ophthalmology. It aims to improve precision, procedural efficiency and patient safety compared to existing adapted injection methods. Currently, intravitreal injections — essential injections for treating retinal diseases like wet age-related […]
Optical/Ophthalmic
SpyGlass Pharma shares positive data for drug-eluting intraocular lens
SpyGlass Pharma released 18-month follow-up data highlighting the potential of its intraocular lens (IOL)-based drug delivery platform. Data came from a first-in-human study of 23 patients with glaucoma or ocular hypertension. They received the IOL implant at the time of cataract surgery. The company reported a consistent sustained reduction of intraocular pressure (IOP) across all […]
Clearside Biomedical’s drug-device combo study meets endpoints
Clearside Biomedical (Nasdaq:CLSD) today announced that the ODYSSEY study of its drug-device combination achieved its primary and secondary outcomes. Alpharetta, Georgia-based Clearside develops the SCS Microinjector suprachoroidal injection device. It enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina, or choroid to […]
Eyenovia begins manufacturing next-gen drug delivery system
Eyenovia (Nasdaq:EYEN) announced that it began manufacturing batches of its Mydcombi product for its next-generation delivery platform. Manufacturing registration batches of the FDA-approved Mydcombi mydriasis product marks a key step in the approval process for the company’s state-of-the-art Gen-2 Optejet dispensing platform, according to a news release. The company plans to have Mydcombi undergo 12-month […]
Roche, Genentech to reintroduce drug-eluting eye implant in U.S. following 2022 recall
Roche subsidiary Genentech today reintroduced its Susvimo therapy for delivery via ocular implant in the U.S. following a recall. The FDA approved a post-approval supplement to Susvimo’s Biologics License Application (BLA). Approval reflects component-level updates made to the ocular implant and refill needle. Roche now plans to work to make Susvimo available in the U.S. […]
Glaukos to exchange $230M in senior notes for common stock
Glaukos (NYSE:GKOS) announced today that it entered into exchange agreements to repurchase approximately $230 million. The company entered into separate, privately negotiated exchange agreements with certain holders of 2.75% convertible senior notes due 2027. Pursuant to these agreements, the company agreed to repurchase $230 million of existing convertible notes for aggregate consideration of shares of […]
Clearside Biomedical prices $15M offering
Clearside Biomedical (Nasdaq:CLSD) announced that it entered into a securities purchase agreement worth proceeds of approximately $15 million. The company agreed with institutional investors and an existing stockholder on the purchase and sale of 11.1 million shares of common stock and warrants. It set the offer price for one share of common stock and warrant […]
FDA approves Glaukos iDose TR glaucoma-treating drug delivery implant
Glaukos (NYSE:GKOS) announced today that the FDA approved a New Drug Application (NDA) for its iDose TR implant. The approval allows for one administration per eye of iDose TR (travoprost intracameral implant) 75 mcg. The indication for the prostaglandin analog covers the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle […]
iStar Medical continues European MINIject rollout with first procedures in Ireland
iStar Medical announced today that it expanded the commercial rollout of its MINIject device with the first implants in Ireland. MINIject, a minimally invasive glaucoma surgery (MIGS) device, treats open-angle glaucoma. Currently the only commercially available supraciliary MIGS implant, it has demonstrated meaningful and sustained performance, plus a favorable safety profile. The device combines the […]
FDA issues warning about over-the-counter eye drops
The FDA issued a notice warning consumers about 26 over-the-counter eye drop products that could result in eye infections. In its notice, the FDA instructed consumers not to purchase and to immediately stop using these products. Using those eye drops could lead to the risk of infections that could result in partial vision loss or […]
