Fremont, Calif-based ophthalmic information system developer Visunex Medical said it won FDA 510(k) clearance for its Panocam LT wide-field imaging system for newborns. The PanoCam LT is a small wireless imaging system designed to detect external, anterior and posterior segment vision disorders that could have long-term effects on children’s vision, the company said. “We are […]
Optical/Ophthalmic
Avedro raises $32m
Avedro said today it closed a $32 million round of equity financing to support the global distribution of its KXL corneal cross-linking platform and commercialization of its Mosaic photorefractive intrastromal cross-linking system. The round was led by new investors InterWest Partners and OrbiMed and joined by several existing investors, Waltham, Mass.-based Avedro said. “The Avedro corneal cross-linking technology […]
InnFocus wins FDA clearance for glaucoma trial expansion
InnFocus said today it won FDA approval to expand a clinical study of its Microshunt glaucoma drainage system to cover trabeculectomy. The Microshunt system is designed to help reduce pressure within the eye in patients with moderate and late stage open angle glaucoma, and is intended to be an alternative to traditional glaucoma surgery, the […]
ReVision Optics files for PMA for presbyopia inlay
ReVision Optics said today the FDA accepted its premarket approval application for the Raindrop near vision inlay. The Raindrop is a microscopic hydrogel inlay for treating presbyopia, which the Lake Forest, Calif.-based company said could reduce or eliminate the need for reading glasses. The inlay is placed in the cornea of the patient’s non-dominant eye […]
Glaukos touts 3-year data from iStent trial
Glaukos (NYSE:GKOS) today released data from a 3-year study of its iStent travecular micro-bypass stent, touting sustained reductions in intra-ocular pressure after treatment with 2 of the devices. The study was published in the November issue of the Clinical Ophtalmology journal, the company said. The iStent trabecular micro-bypass stent is a tiny titanium stent designed to […]
Avedro wins Chinese approval for KXL eye treatment
Avedro said today it won Chinese Food and Drug Administration approval for its KXL cross-linking eye treatment device for treating keratoconus and post-lasic ectasia. Avedro said the clearance made the KXL system the 1st and only corneal coss-linking device to win approval in the People’s Republic of China. “As the 1st ophthalmic surgeon in China to use […]
Inside Valeant’s ambitious plan for its contact lens business
(Reuters) — Valeant Pharmaceuticals (NYSE:VRX, TSE:VRX) has pursued a plan in recent months to dominate the market for specialty contact lenses, according to 2 people familiar with the company’s approach and some of the company’s communications with its customers. The Canadian drugmaker’s goal, spelled out to key employees and demonstrated through its actions, has been to acquire […]
Glaukos, Transcend Medical settle spat over eye stent patents
Glaukos (NYSE:GKOS) said yesterday that it agreed to settle a patent infringement lawsuit brought by eye stent rival Transcend Medical. The agreement, in which both sides agree not to sue for patent infringement, calls for Transcend to pay a 1% royalty on sales of its Cy-Pass micro-stent until April 2022, with the total amount capped at $6 […]
Novartis: Alcon reorg on tap for 2016
(Reuters) — Novartis (NYSE:NVS) has agreed in principle to pay $390 million to settle U.S. allegations that it used kickbacks to speciality pharmacies to push sales of some drugs, the Swiss company said today, hitting 3rd-quarter earnings. The U.S. Justice Dept. had sued Novartis in a Manhattan federal court, saying the world’s biggest seller of prescription drugs sought […]
Justice Dept., FTC probe Valeant’s Bausch & Lomb, Paragon lens operations
The U.S. Justice Dept. and the Federal Trade Commission are investigating Valeant Pharmaceuticals (NYSE:VRX, TSE:VRX) subsidiaries Bausch & Lomb and Paragon Vision Sciences, the Canadian drug maker said yesterday. The Justice Dept. is looking into payments Bausch & Lomb made to doctors using its Crystalens intra-ocular lens and Victus eye laser, Valeant said yesterday in a regulatory […]
Transcend Medical finalizes PMA bid for CyPass glaucoma stent
Transcend Medical said today that it filed the final module in its pre-market approval application with the FDA for the CyPass micro-stent glaucoma treatment. Menlo Park, Calif.-based Transcend said the PMA bid is based on its Compass trial, which met its primary endpoint of 20% or greater reduction in intraocular pressure. The 500-patient study of subjects with […]