With the help of $61 million from EW Healthcare Partners and a third-party investor, pSivida (NSDQ:PSDV) announced today that it acquired Icon Bioscience and its FDA-approved dexamethasone intraocular suspension designed to treat postoperative inflammation. The two companies combined and plan to do business as EyePoint Pharmaceuticals. pSivida also landed a $20 million debt facility from SWK Holdings Corp., to […]
FDA to review pSivida’s ocular drug-delivery system
pSivida (NSDQ:PSDV) said yesterday that the FDA plans to review the company’s application for its drug-releasing ocular insert, Durasert. The product is designed to provide three years of treatment for patients with posterior segment uveitis. The U.S. regulatory agency is slated to decide whether or not to approve pSivida’s new drug application by Nov. 5. Get […]
pSivida touts 12-month data from Ph3 trial of Durasert ocular insert
pSivida (NSDQ:PSDV) touted results today from a second Phase III trial that the company conducted for its three-year posterior segment uveitis treatment. The 153-patient study found that there was a significant reduction in the recurrence of posterior segment uveitis through 12 months in the group treated with pSivida’s drug-releasing ocular insert, Durasert. Get the full story […]
pSivida seeks FDA nod for 3-year treatment of posterior segment uveitis
pSivida (NSDQ:PSDV) has submitted a new drug application to the FDA for its Durasert implant that provides three years of treatment for people with posterior segment uveitis. The drug-delivery product’s NDA includes data from two Phase III trials, both of which met their primary efficacy endpoints after six months. Get the full story at our sister […]
pSivida touts pilot osteoarthritis trial for Durasert implant
pSivida (NSDQ:PSDV) touted results today from a Phase I safety and efficacy pilot trial of its sustained-release Durasert implant in patients with osteoarthritis of the knee. The company’s Durasert tech, combined with an implantable device from the Hospital for Special Surgery, was designed to continuously deliver a low dose of dexamethasone into the knee joint. Six patients […]
pSivida licenses European rights for Durasert to Alimera
pSivida (NSDQ:PSDV) said today that it restructured a deal with Alimera Sciences (NSDQ:ALIM) to grant Alimera rights to the Durasert three-year treatment for posterior segment uveitis in Europe, the Middle East and Africa. Alimera, which holds an exclusive license to pSivida’s intravitreal implant, Iluvien, plans to apply for a secondary indication for Iluvien for posterior segment uveitis. Get […]
pSivida seeks European regulatory nod for Durasert
pSivida (NSDQ:PSDV) is looking to market its Durasert 3-year treatment for posterior segment uveitis in the European Union. Today, the Watertown, Mass.-based company submitted a marketing authorization application to the European Medicines Agency. Earlier this month, pSivida reported that its 2nd Phase III trial, which followed patients for 3 years, met its primary endpoint of […]
pSivida implant meets primary endpoint in late-stage trial
pSivida (NSDQ:PSDV) touted data from the 2nd Phase III trial of its Durasert 3-year treatment for posterior segment uveitis. The company reported that the trial, which followed patients for 3 years, met its primary endpoint of prevention of recurrence of posterior uveitis at 6 months. In the 153-patient trial, 21.8% of Durasert-treated patients had a […]
Study: pSivida’s Durasert lessens recurrence of uveitis through 12 months
pSivida (NSDQ:PSDV) touted 1-year follow-up data yesterday for the company’s Durasert 3-year treatment of posterior segment uveitis. The data, which was presented at the Association for Research in Vision and Ophthalmology annual meeting, is from pSivida’s 1st phase III trial. The data showed that the 3-year uveitis implant significantly reduced the recurrence of posterior segment uveitis […]
pSivida shares gain on Q2 earnings
Shares in pSivida (NSDQ:PSDV) rose yesterday after the medical device maker met expectations on Wall Street with its fiscal 2nd quarter results. The Watertown, Mass.-based company pared its losses to -$0.1 million, or 0¢ per share, on sales of $6 million for the 3 months ended Dec. 31, for bottom-line growth of 98.7% on sales […]
pSivida misses Q3 estimates, profits slide 47%
Shares in pSivida (NSDQ:PSDV) fell 6% today after the company missed expectations on Wall Street with its fiscal 1st-quarter results. The Watertown, Mass.-based company posted losses of -$7.2 million, or -21¢ per share, on sales of $277,000 for the 3 months ended Sept. 30, for a bottom-line loss of -47% on a -41% sales decline, compared […]
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