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Alimera, pSivida amend licensing agreement
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Alimera Sciences may now seek approval of Iluvien for the secondary indication of posterior uveitis in the European Union, Middle East and Africa, according to a press release from the company.
Alimera and pSivida amended a previous agreement, under which “Alimera held the worldwide license from pSivida to sell Iluvien for the treatment of all ocular diseases other than uveitis,” the release said.
Iluvien (fluocinolone acetonide intravitreal implant 0.19 mg) is currently approved in the U.S. and 17 EU countries for the treatment of diabetic macular edema, and pSivida will “retain commercialization rights for posterior segment uveitis in all other countries, including the United States,” according to a press release from pSivida.
The restructured global licensing agreement will give Alimera the rights to Durasert under the Iluvien name in the EMEA region in exchange for tiered sales-based royalty payments, according to the pSivida release.
Under the new agreement, pSivida will withdraw a centralized EU application for the drug’s indication for posterior uveitis and Alimera will file an application for the indication in the countries where it is currently approved for DME.
“pSivida has met its primary endpoint at 6 months in two phase 3 clinical trials for posterior uveitis, which we anticipate will support the approval of Iluvien for the treatment of posterior uveitis in these regions,” Dan Myers, CEO of Alimera, said in the Alimera release.
According to Nancy Lurker, pSivida president and CEO, the company continues to be “on track” to file a new drug application with the FDA by the end of this year.