Alimera Sciences Announces Approval Received in the Mutual Recognition Procedure for New Indication for ILUVIEN in Europe

 Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmic pharmaceuticals, today announced a positive outcome for a new indication for ILUVIEN in Europe. Alimera received the Final Variation Assessment Report (FVAR) for ILUVIEN from the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) based on Alimera's submission to the MHRA through the Mutual Recognition Procedure. Under that procedure, the United Kingdom has acted as the Reference Member State and prepared an assessment report to share with the 16 other countries in the EEA in which Alimera applied for an additional indication. The FVAR states that ILUVIEN is approved for the additional indication for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU). NIPU, which is difficult to treat and primarily affects working age people, can lead to severe vision loss and even blindness.

"The priority when treating patients with NIPU is preventing recurrence of the condition and preserving vision. ILUVIEN has shown to successfully decrease uveitis recurrence rates and reduce vision loss, which will positively impact our patients," said Mr. Carlos Pavesio, Specialist Uveitis Consultant Ophthalmologist at Moorfields Eye Hospital, London, U.K. "This is most welcome news and provides an effective additional option for a condition that can be difficult to treat."

ILUVIEN is a sustained release intravitreal implant that controls the recurrence of diabetic macular edema and prevents the relapse of the recurrence of NIPU every day through its CONTINUOUS MICRODOSING™ technology, enabling patients to maintain vision longer with fewer injections.

"Adding this indication in our key European markets is a critical component of our growth strategy," said Rick Eiswirth, Alimera's President and Chief Executive Officer. "We are also very pleased with this indication as it further reinforces our belief in ILUVIEN's ability to continuously and consistently deliver treatment for up to 3 years, reducing the recurrence of inflammation."

The regulatory process will now enter the national phase in which the U.K. and each additional European member state are expected to finalize the label for the new indication to meet each country's local requirements. Timeline to this goal varies by each country.

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