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 […]
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 […]
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, […]
Clearside Biomedical seeks FDA nod for macular edema injection
Clearside Biomedical (NSDQ:CLSD) said this week that it submitted a new drug application to the FDA for Xipere – a suprachoroidal injection designed for the treatment of macular edema associated with uveitis. The Alpharetta, Ga.-based company noted that if Xipere is approved by the FDA, it would be the first therapy for macular edema associated with […]
Clearside Biomedical’s combo therapy fails in Ph3 retinal vein occlusion trial
Clearside Biomedical (NSDQ:CLSD) said today that its lead drug, in combination with Regeneron‘s (NSDQ:REGN) Eylea, failed in a phase III retinal vein occlusion trial. The trial’s primary endpoint was the proportion of patients in the combination treatment arm, compared to the group receiving just intravitreal Eylea, that experienced improvements in best corrected visual acuity after eight weeks. […]
Clearside Biomedical reports analyses from pivotal trial of eye drug
Clearside Biomedical (NSDQ:CLSD) touted new analyses of data from the company’s Phase III pivotal trial of suprachoroidal CLS-TA in people with uveitic macular edema. The company’s investigational treatment is a suspension of triamcinolone acetonide formulated to be delivered to the back of the eye via the suprachoroidal space. Clearside reported that 40% of people taking its […]
Clearside Biomedical posts Street-beating Q4, full year results
Shares in Clearside Biomedical (NSDQ:CLSD) fell today even though the biopharmaceutical company topped sales and earnings estimates on Wall Street with its fourth quarter and full year results. The Alpharetta, Ga.-based company posted a net loss of -$16.5 million on sales of $55,000 for the three months ended Dec. 31, for bottom-line loss of -70% on […]
Clearside Biomedical prices $85m underwritten offering
Clearside Biomedical (NSDQ:CLSD) priced 6,538,462 shares of its common stock at $13.00 apiece in an $85 million underwritten public offering that’s expected to close early next week. The Alpharetta, Ga.-based company is slated to use the funds to prepare and submit an application to the FDA for its suprachoroidal eye drug as a treatment for patients […]
Clearside Biomedical floats $75m public offering
Clearside Biomedical (NSDQ:CLSD) plans to offer $75 million in shares of its common stock in an underwritten public offering. The Alpharetta, Ga.-based company is slated to use the funds to prepare and submit an application to the FDA for its suprachoroidal eye drug as a treatment for patients with macular edema associated with non-infectious uveitis. Clearside […]
Clearside Biomedical enrolls first patient in Ph3 macular edema trial
Clearside Biomedical (NSDQ:CLSD) has enrolled the first patient in a Phase III trial evaluating its eye drug combined with an intravitreally-administered anti-VEGF agent as a treatment for macular edema associated with retinal vein occlusion. The company’s drug, CLS-TA, is a proprietary suspension of triamcinolone acetonide designed to be administered in the space located between the choroid […]
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