The FDA has approved Heidelberg Engineering’s optical coherence tomography angiography module (OCTA), the company said today. The module is available for new and existing Spectralis upgradeable diagnostic imaging devices used to manage diabetic retinopathy, age-related macular degeneration and other macular diseases. OCTA is a noninvasive imaging technique that provides three-dimensional visualization of perfused ocular vasculature. Structural OCT uses […]
Second Sight Medical wins $2m NIH grant for Orion sight implant
Second Sight Medical (NSDQ:EYES) said today that it won a grant of nearly $2 million from the National Institutes of Health to back the early feasibility trial of its Orion device for the visually impaired. The Sylmar, Calif.-based company said the $1.6 million grant is part of a five-year, $6.3 million package that’s slated to […]
Staar Surgical wins FDA nod for Visian Toric ICL
Staar Surgical (NSDQ:STAA) said yesterday that it won FDA approval for its Visian toric implantable collamer lens designed for correcting myopia with astigmatism. The Monrovia, Calif.-based company said that with the approval, its ICL product line is now cleared for the correction of refractive errors in patients with both myopia and astigmatism. Staar Surgical said that its […]
FDA to review Regeneron’s Eylea for diabetic retinopathy
Regeneron Pharmaceuticals (NSDQ:REGN) said today that the FDA plans to review the supplemental biologics license application for Regeneron’s Eylea aflibercept injection for the treatment of diabetic retinopathy. The U.S. agency plans to make a decision about the blockbuster drug by May 13, 2019. Get the full story at our sister site, Drug Delivery Business News.
Iridex wins FDA 510(k) for TruFocus LIO premiere ophthalmological laser
Iridex (NSDQ:IRIX) said yesterday it won FDA 510(k) clearance for its TruFocus LIO premiere ophthalmological laser accessory and that it launched the device in the US. The TruFocus LIO Premiere is a light combination and reflection viewing system designed to be used with the Iridex retina laser system, the Mountain View, Calif.-based company said. The newly […]
Swiss Advanced Vision launches Harmonis customizable IOL
Swiss Advanced Vision said yesterday it launched its Harmonis customizable intraocular lens system designed for cataract surgery. The newly launched system features advanced extended depth of focus optical technology, the Neuchatel, Switzerland-based company said, and a web-based configurator ophthalmologists can use prior to surgery to select optimal lens parameters. The web-based configurator offers selectable parameters […]
EyePoint nabs CMS reimbursement for Dexycu cataract surgery drug
EyePoint Pharmaceuticals (NSDQ:EYPT) said this week that the Centers for Medicare and Medicaid Services approved transitional pass-through status and reimbursement of its dexamethasone intraocular suspension, Dexycu. The FDA-approved product is designed to treat inflammation following cataract surgery using a single, intraocular dose of long-acting dexamethasone. Get the full story at our sister site, Drug Delivery Business […]
EyeGate’s Phase 3 EGP-437 study fails to show non-inferiority
Ophthalmalogical-focused developer EyeGate Pharma said this week that the Phase 3 study of its EGP-437 delivered through its EyeGate II drug delivery system did not show non-inferiority to the prednisolone acetate ophthalmic solution control group. The Phase 3 study was evaluating the safety and efficacy of the EGP-437 with the EyeGate II in patients with […]
Alcon withdraws all CyPass micro-stents, says it will not affect spin-off
Novartis (NYSE:NVS)’s Alcon said this week it is voluntarily withdrawing its CyPass micro-stents from the global market, but that the withdrawal will not affect its planned spin-out. The decision to pull the devices comes off the analysis of five-year post-surgery data from the Compass-XT study of the device, which showed that patients treated with the stent had […]
Kala Pharma wins FDA nod for twice-daily ocular corticosteroid
The FDA has approved Kala Pharmaceuticals’ (NASDAQ:KALA) Inveltys to treat post-operative inflammation and pain following ocular surgery. Inveltys is the first twice-daily (BID) ocular corticosteroid approved for this indication, according to the Waltham, Mass. company. While corticosteroids are used following ocular surgery to control inflammation and pain, physicians prescribe ocular steroids to achieve a rapid reduction of […]
Second Sight inks $5m private placement deal
Second Sight Medical (NSDQ:EYES) said today it inked a $5 million private placement deal with funds slated to support continued development and testing of its implantable visual prosthetic technology. The Los Angeles-based company said it is selling approximately 3.2 million shares of common stock at $1.55 per share to entities owned by its board chair Gregg […]
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