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pSivida Corp. (NASDAQ:PSDV): Authorization to ILUVIEN in Spain

pSivida (NASDAQ: PSDV) is a leading provider of miniaturized, sustained-release drug delivery products and is continuing the evolution of these systems.
PSDV proprietary technologies enable to achieve highly focused, long-term delivery of therapeutics. Company has developed three of the only four products approved by either the US or EU for the long-term, sustained-released delivery of drug to treat chronic eye disease.

pSivida’s Durasert Technology is a miniaturized, injectable, sustained-release drug delivery system designed to advance the treatment of medical conditions in critical areas, such as ophthalmology. Durasert enables the development of drug delivery devices that:

  • Bioerodible or non-erodible
  • Administered in office visit
  • Linear sustained-release kinetics (days/weeks/months/years)
  • Injectable via needles as small as 25-guage
  • Highly efficient/drug loading (up to 80%)

PSDV announced today that the Spanish Agency of Drugs and Medical Devices (Agencia Espanola de Medicamentos y Productos Sanitarios) granted marketing authorization to ILUVIENĀ® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

PSDV’s ILUVIENĀ® has been previously approved in the EU, preceded by Austria, the United Kingdom, Portugal, France and Germany.

Company’s licensee Alimera Sciences, Inc. continues to work with the Italian regulatory authorities after the completion of the Decentralized Regulatory Procedure (DCP) in the European Union (EU), in which the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, serving as the Reference Member State (RMS), delivered a positive outcome for ILUVIEN along with six Concerned Member States (CMS).

Dr. Paul Ashton, President and CEO, commented

We are pleased that ILUVIEN has now been granted marketing authorizations in six of the seven EU countries in which approval has been sought and look forward to its commercial launch in the EU.