Innovation finds its way into all areas of medtech, and ophthalmic treatments represent another burgeoning space. It may not be a new wave, but medtech companies continue to improve upon technologies for the human eye. Implants, lenses and more comprise the space’s latest innovations, with a number of companies finding new ways to fix old […]
Clearside Biomedical
Bausch + Lomb, Clearside Biomedical launch Xipere in U.S.
Bausch Health’s (NYSE:BHC) Bausch + Lomb and Clearside Biomedical (Nasdaq:CLSD) launched their Xipere product in the U.S. today. Clearside Biomedical designed the Xipere triamcinolone acetonide suprachoroidal injectable suspension therapy with a proposed indication for treating macular edema associated with uveitis, a form of eye inflammation. Xipere works with Clearside’s proprietary SCS Microinjector to deliver the therapy to […]
FDA accepts resubmitted NDA for Xipere from Clearside Biomedical, Bausch Health
Bausch Health (NYSE:BHC) and Clearside Biomedical (NSDQ:CLSD) announced today that the FDA accepted their resubmitted new drug application for Xipere. Clearside Biomedical designed the investigational Xipere triamcinolone acetonide suprachoroidal injectable suspension therapy with a proposed indication for the treatment of macular edema associated with uveitis. Xipere works with Clearside’s proprietary SCS Microinjector to access the back of the […]
Regenxbio pulls trigger on option to license Clearside Biomedical’s SCS Microinjector
Clearside Biomedical (NSDQ:CLSD) said yesterday that Regenxbio (NSDQ:RGNX) exercised its option to license Clearside’s in-office SCS Microinjector for delivering adeno-associated virus (AAV)-based therapeutics in treating wet age-related macular degeneration, diabetic retinopathy and other conditions. The two companies inked the option and licensing deal that they said at the time could be worth more than $130 million on […]
Clearside Biomedical inks $76m licensing deal with Bausch for Xipere
Clearside Biomedical (NSDQ:CLSD) said yesterday that it entered into a license agreement with Bausch Health Ireland (NYSE:BHC) worth up to $76 million for the Xipere device for the treatment of macular edema associated with uveitis. The agreement grants Bausch an exclusive license to develop, manufacture, distribute, promote, market and commercialize the suprachoroidal injection device. Get the full […]
Clearside Biomedical confirms timeline for Xipere
Clearside Biomedical (NSDQ:CLSD) last week said that the FDA found no efficacy issues with its Xipere drug-delivery technology and will not ask for further clinical efficacy studies. The Xipere device is a suprachoroidal injection designed for the treatment of macular edema associated with uveitis. In October 2018, Clearside touted data from a Phase III pivotal trial, which reported […]
Clearside Biomedical, Regenxbio ink sales deal for gene therapy microinjector
Clearside Biomedical (NSDQ:CLSD) has agreed to grant Regenxbio (NSDQ:RGNX) the option to an exclusive worldwide license to sell Clearside’s SCS gene therapy microinjector. The option and licensing deal is potentially worth more than $130 million, the companies said. Get the full story on our sister site, Drug Delivery Business News.
FDA wants more on new manufacturing process from Clearside Biomedical
Clearside Biomedical (NSDQ:CLSD) said today that the FDA ordered the company to provide stability data on its new manufacturing process for triamcinolone acetonide suspension, pushing the timeline on the agency’s decision into next year. Alpharetta, Ga.-based Clearside’s Xipere device is a suprachoroidal injection designed for the treatment of macular edema associated with uveitis. Clearside said the […]
Clearside Biomedical licenses microinjector to Aura Biosciences
Clearside Biomedical (NSDQ:CLSD) said today that it licensed its microinjector technology to Aura Biosciences for use with Aura drug candidates in treating ocular cancers. Alpharetta, Ga.-based Clearside’s Suprachoroidal Space Microinjector is designed to deliver therapeutics into the suprachoroidal space between the sclera and choroid of the eye. Aura, based in Cambridge, Mass., is developing viral nanoparticle […]
Medtronic taps Lennon as CIO | Personnel Moves – April 9, 2018
Medtronic (NYSE:MDT) said that it named Sean Lennon as its new chief information officer, set to take effect April 29. The Fridley, Minn.-based medtech giant said that Lennon will take over for Mike Hedges, who is retiring from the position after 19 years with Medtronic, including 10 as CIO. Prior to joining Medtronic, Lennon served as […]
Clearside Biomedical shares down on Q4 miss
Shares in Clearside Biomedical (NSDQ:CLSD) have fallen slightly today after the biopharmaceutical company posted fourth quarter 2018 earnings that missed expectations on Wall Street. The Alpharetta, Ga.-based company reported research and development costs of approximately $17.5 million with a total net loss of $21.6 million, or 68¢ per share, for the three months ended December 31, […]
