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Last $4.06 USD
Change Today +0.07 / 1.75%
Volume 51.4K
As of 8:10 PM 04/20/15 All times are local (Market data is delayed by at least 15 minutes).

psivida corp (PSDV) Snapshot

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52 Week High
09/3/14 - $4.94
52 Week Low
04/21/14 - $3.31
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psivida corp (PSDV) Details

pSivida Corp. develops products to deliver drugs and biologics in the United States and the United Kingdom. The company develops its products based on its Durasert and Tethadur drug delivery technologies focusing on the treatment of chronic diseases of the back of the eye. It offers ILUVIEN, an injectable, sustained-release micro-insert for use in treating vision impairment associated with diabetic macular edema; and Retisert for the treatment of posterior uveitis. The company also provides Medidur, an injectable, sustained-release micro-insert designed to treat non-infectious uveitis affecting the posterior segment of the eye, which is in Phase III clinical trial.It has strategic collaborations with Alimera Sciences, Inc.; Pfizer, Inc.; Bausch & Lomb Incorporated; Enigma Therapeutics Limited; and Intrinsiq Materials Cayman Limited. The company was founded in 1987 and is headquartered in Watertown, Massachusetts.

24 Employees
Last Reported Date: 09/11/14
Founded in 1987

psivida corp (PSDV) Top Compensated Officers

Chief Executive Officer, President and Execut...
Total Annual Compensation: $708.6K
Principal Financial & Accounting Officer and ...
Total Annual Compensation: $316.0K
Vice President of Corporate Affairs, General ...
Total Annual Compensation: $433.5K
Compensation as of Fiscal Year 2014.

psivida corp (PSDV) Key Developments

pSivida Corp. Reports Approval of ILUVIEN® for DME in Poland

pSivida Corp. announced that the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Poland has granted marketing authorization to ILUVIEN for the treatment of vision impairment associated with diabetic macular edema (DME) considered insufficiently responsive to available therapies. This marks the completion of the latest round of EU authorizations with ILUVIEN now approved in 17 European countries.

pSivida Corp. Completes Targeted Enrollment of Phase III Trial of Medidur for Posterior Uveitis

pSivida Corp. announced the completion of the originally targeted enrollment of 120 patients in its pivotal Phase III clinical trial of Medidur™ for the treatment of posterior uveitis, a blinding eye disease. pSivida will permit 10 additional patients seeking entry into the trial who met the entry criteria to enroll. pSivida expects to report top line data from the trial in the second half of 2016, and based on the results, to file for regulatory approval in late 2016 or early 2017. Medidur is an injectable micro-insert delivering the steroid flucinolone acetonide (FA) on a sustained basis for 36 months. Medidur uses the same micro-insert (same design, same polymers, same drug, same dose) as ILUVIEN for diabetic macular edema (DME) developed by pSivida, which has been approved in the U.S. and in 15 EU countries to date. Medidur is inserted via a redesigned applicator that utilizes a needle of the same gauge as that typically used for intra-ocular injections. Posterior uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina. It afflicts people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. In the U.S., posterior uveitis affects approximately 175,000 people, resulting in approximately 30,000 cases of blindness making it the third leading cause of blindness in the U.S. Patients with posterior uveitis are typically treated with systemic steroids but over time frequently develop serious side effects that can limit effective dosing. Patients then progress to steroid-sparing therapy with systemic immune suppressants or biologics, which themselves can have severe side effects including an increased risk of cancer. The Medidur Phase III trial is a double-blind study comparing injections of Medidur to sham injections on a two-to-one basis. Patients are enrolled in 16 centers in the U.S. and 17 centers in the EU and India. The primary end point of the trial is recurrence of posterior uveitis within one year. pSivida plans to seek approval based on the safety and efficacy data from this single Phase III trial together with short term data from a utilization study of pSivida’s proprietary inserter. The FDA has confirmed that pSivida can reference much of the data, including the clinical safety data, from the Phase III clinical trials of ILUVIEN for DME.

pSivida Corp. Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended December 31, 2014

pSivida Corp. reported unaudited consolidated earnings results for the second quarter and six months ended December 31, 2014. For the quarter, the company reported total revenues of $521,000 against $592,000 a year ago. Loss from operations was $4,116,000 against $3,541,000 a year ago. Loss before income taxes was $4,113,000 against $3,540,000 a year ago. Net loss was $4,075,000 or $0.14 per share diluted against $3,514,000 or $0.13 per share diluted a year ago. For the six months, the company reported total revenues of $25,828,000 against $1,189,000 a year ago. Income from operations was $16,673,000 against loss from operations of $7,259,000 a year ago. Income before income taxes was $16,679,000 against loss before income taxes of $7,257,000 a year ago. Net income was $16,491,000 or $0.54 per share diluted against net loss of $7,201,000 or $0.27 per share diluted a year ago. Net cash provided by operating activities was $17,257,000 against net cash used in operating activities of $6,034,000 a year ago. Purchases of property and equipment were $28,000 against $21,000 a year ago. Net book value at December 31, 2014 was $2,301,000 against 2,765,000 as on June 30, 2014.


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