IluvienTreatment for Diabetic Macular Edema
pSivida Announces Resubmission of New Drug Application for Iluvien
WATERTOWN, Mass.--(BUSINESS WIRE)--March 27, 2014 -- pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the New Drug Application for Iluvien for the treatment of chronic Diabetic Macular Edema has been resubmitted to the U.S. Food and Drug Administration (FDA). In the resubmission, pSivida's licensee, Alimera Sciences, responded to questions raised in the FDA's October 2013 complete response letter and provided a safety update, which included commercial experience with Iluvien in Europe.
Alimera is awaiting the FDA's acceptance of the resubmission and a Prescription Drug User Fee Act (PDUFA) date. pSivida will report that information when it becomes available.
"We are pleased with the resubmission of the NDA for Iluvien, which brings us one step closer to potential approval in the United States," said Paul Ashton, pSivida's president and chief executive officer.
About pSivida Corp.
pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert™ and Tethadur™. The injectable, sustained release micro-insert Iluvien® for the treatment of chronic DME considered insufficiently responsive to available therapies, licensed to Alimera Sciences, Inc., is marketed in the U.K. and Germany and has also received marketing authorization in Austria, France, Portugal, and Spain and is awaiting authorization in Italy. Alimera has filed for ten additional EU country approvals through the Mutual Recognition Procedure. Alimera is seeking FDA approval for Iluvien for DME in the US. pSivida has instituted the first of two planned pivotal Phase III clinical trials of Medidur™ for the treatment of posterior uveitis, a chronic back-of-the-eye disease, which uses the same micro-insert as Iluvien. An investigator-sponsored clinical trial is ongoing for an injectable, bioerodible micro-insert to treat glaucoma and ocular hypertension, a product candidate on which Pfizer Inc. has an option. pSivida's FDA-approved Retisert®, licensed to Bausch & Lomb Incorporated, provides long-term, sustained drug delivery to treat posterior uveitis.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. The following are some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements: uncertainties with respect to: Alimera's ability to obtain regulatory approval for, and if approved, to finance, successfully commercialize and achieve market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in the U.S.; Alimera's ability to finance, achieve additional marketing approvals, obtain adequate pricing and reimbursement for, successfully commercialize and achieve market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in the EU; the ability to finance, complete and achieve a successful outcome for Phase III trials for, and file and achieve marketing approvals for, Medidur for posterior uveitis, including achieving acceptable risk-to-benefit and safety profiles in light of the CRL for ILUVIEN; initiation, financing and success of Latanoprost Product Phase II trials and any exercise by Pfizer of its option; ability of Tethadur to successfully deliver proteins, peptides and other large biologic molecules; ability to develop product candidates and products and potential related collaborations; initiation and completion of clinical trials and obtaining regulatory approval of product candidates; continued sales of Retisert; adverse side effects; ability to attain profitability; ability to obtain additional capital; further impairment of intangible assets; fluctuations in operating results; decline in royalty income; ability to, and to find partners to, develop and market products; termination of license agreements; competition and other developments affecting sales of products; market acceptance; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; consolidation in the pharmaceutical and biotechnology industries; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; credit and financial market conditions; legislative or regulatory changes; volatility of stock price; possible dilution; absence of dividends; and other factors described in our filings with the SEC. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
Source: pSivida Corp.
Posted: March 2014
- FDA Approves Iluvien for Diabetic Macular Edema - September 26, 2014
- Alimera Sciences Announces New PDUFA Date For Iluvien - April 14, 2014
- Alimera Sciences Receives Complete Response Letter For Iluvien - October 18, 2013
- pSivida Reports on Resubmission to FDA of NDA for Iluvien for Chronic Diabetic Macular Edema - April 2, 2013
- pSivida Reports Updates on Iluvien for Planned Resubmission to FDA and European Launch - March 22, 2013
- pSivida Corp. Reports Alimera's Intention to Resubmit Application to FDA for Iluvien in DME Using Data from Completed Trials - August 1, 2012
- pSivida Reports Receipt by Alimera Sciences of Complete Response Letter from FDA for Iluvien for DME - November 11, 2011
- pSivida Announces Resubmission of New Drug Application for Iluvien - May 13, 2011
- FDA Issues Complete Response Letter Regarding New Drug Application for Iluvien - December 26, 2010
- pSivida Announces Iluvien Receives FDA Priority Review for Treatment of Diabetic Macular Edema - August 31, 2010
- pSivida Announces Submission of NDA to FDA for an Ophthalmic Product for Diabetic Macular Edema - June 29, 2010