pSivida partner files fourth US NDA for Iluvien
Alimera Sciences has once more resubmitted a New Drug Application (NDA) in the US for Iluvien, a treatment for diabetic macular edema that uses a pSivida (ASX:PVA) insert.
The new resubmission addresses the concerns addressed in the US FDA’s latest knockback for the application as well as a safety update, pSivida announced.
Alimera has now filed four NDAs for the treatment, and the FDA has issued three separate complete response letters. The latest letter was issued in October last year.
Should the FDA accept the resubmission, the agency will set a new PDUFA date - the deadline for the agency’s decision whether to approve the drug.
“We are pleased with the resubmission of the NDA for Iluvien, which brings us one step closer to approval in the United States,” pSivida CEO Paul Ashton said.
pSivida has independently developed a treatment for posterior uveitis using the same sustained release micro-insert as Iluvien, and FDA approval for the latter will go a long way towards bringing the former treatment into the market.
Earlier this month, pSivida received a US$7 million ($7.6 million) funding injection from the sale of 1.7 million shares to RA Capital. The company plans to use the proceeds to accelerate the development of its sustained release implant technology and help fund its uveitis trials.
pSivida (ASX:PVA) shares were trading 2.49% lower at $4.30 as of around 2 pm on Monday.
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