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 […]
Clearside Biomedical
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 […]
5 top ophthalmic device innovations you need to know
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 […]
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 […]
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 treating macular edema associated with uveitis. Xipere works with Clearside’s proprietary SCS Microinjector to access the back of […]
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. Bausch agreed to […]
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. The SCS microinjector is designed to deliver adeno-associated virus (AAV) gene therapies to treat wet age-related macular […]
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 […]
