Attached files
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EX-99.1 - EX-99.1 - EyePoint Pharmaceuticals, Inc. | y81152exv99w1.htm |
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): December 23, 2009
PSIVIDA CORP.
(Exact Name of Registrant as Specified in Its Charter)
Delaware (State or Other Jurisdiction of Incorporation) |
000-51122 (Commission File Number) |
26-2774444 (IRS Employer Identification No.) |
400 Pleasant Street
Watertown, MA 02472
(Address of Principal Executive Offices) (Zip Code)
Watertown, MA 02472
(Address of Principal Executive Offices) (Zip Code)
(617) 926-5000
(Registrants Telephone Number, Including Area Code)
(Registrants Telephone Number, Including Area Code)
Not applicable
(Former Name or Former Address, if Changed Since Last Report)
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Section 8 Other Events
Item 8.01. Other Events.
On
December 23, 2009, pSividas collaborative partner, Alimera Sciences, Inc. (Alimera), filed a
Form S-1/A with the Securities & Exchange Commission which reported the 24 month results of the two
Phase 3 pivotal clinical trials (FAME Study) for Iluvien® in the treatment of Diabetic Macular
Edema. Alimera reported that based on these results, it plans to submit a New Drug Application
(NDA) to the Food and Drug Administration (FDA) for approval of the low dose of Iluvien in the
second quarter of 2010, followed by registration filings in various European countries and Canada;
that it intends to request Priority Review of the NDA from the FDA; and that if Priority Review is
granted, it can expect a response to its NDA from the FDA in the fourth quarter of 2010. The
section of Alimeras Form S-1/A entitled BusinessIluvien Clinical Development Program and
certain risk factors relating to the Iluvien clinical development program under Risk Factors are
filed as Exhibit 99.1 to this report and incorporated herein by reference.
Section 9 Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
The following Exhibit is filed with this report on Form 8-K:
No. | Description | |
99.1
|
BusinessIluvien Clinical Development Program and certain risk factors relating to the Iluvien clinical development program under Risk Factors from Form S-1/A of Alimera, Registration No. 333-162782, filed December 23, 2009. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
PSIVIDA CORP. |
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Date: December 23, 2009 | By: | /s/ Lori Freedman | ||
Lori Freedman, | ||||
Vice President, Corporate Affairs, General Counsel and Secretary |
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