Phase III Clinical Study IND Accepted in China for Alimera’s Fluocinolone Acetonide Intravitreal Implant

Rhea-AI Summary

Alimera Sciences (Nasdaq: ALIM) announced that its partner, Ocumension Therapeutics, received approval from the National Medical Products Administration for an IND application to initiate a Phase III clinical study of fluocinolone acetonide intravitreal implant. This study aims to support marketing approval in mainland China for treating diabetic macular edema. The trial is designed to align with Alimera’s existing U.S. indication, targeting patients previously treated with corticosteroids who did not experience significant intraocular pressure increases. Alimera's leadership expresses excitement about this development.

Positive

• Ocumension has received IND approval for a Phase III clinical study in China.
• The study targets diabetic macular edema, aligning with Alimera's existing U.S. indication.

Negative

• None.

ATLANTA, June 08, 2022 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be invaluable to patients, physicians, and partners concerned with retinal health and maintaining better vision longer, announced today that its partner, Ocumension Therapeutics (“Ocumension”) received approval from the National Medical Products Administration for its IND application to begin the Phase III clinical study for fluocinolone acetonide intravitreal implant in support of a filing for marketing approval to treat diabetic macular edema in mainland China.

“We are very excited by the progress that Ocumension is making toward generating the data needed to seek approval in China for our intravitreal implant,” said Rick Eiswirth, President and CEO of Alimera. “We look forward to the start of the trial and to the subsequent data.”

The IND application was for a randomized, multicenter Phase III clinical study of 0.19 mg Fluocinolone Acetonide Intravitreal Implant in the treatment of diabetic macular edema. The intent of the trial is to support a future NDA filing to gain marketing approval in the country with an equivalent indication to Alimera’s U.S. indication (for the treatment of diabetic macular edema previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure).

About Alimera
Alimera is a global pharmaceutical company whose mission is to be invaluable to patients, physicians, and partners concerned with retinal health and maintaining better vision longer. For more information, please visit www.alimerasciences.com

About Ocumension Therapeutics
Ocumension is an ophthalmic pharmaceutical company dedicated to identifying, developing and commercializing first- or best-in-class ophthalmic therapies. The Group has a portfolio of 23 drug assets, covering all major front- and back-of-the-eye diseases, among which seven key drug candidates are in phase III clinical trial stage.

For press inquiries: Jules Abraham for Alimera Sciences 917-885-7378 julesa@coreir.com

For investor inquiries: Scott Gordon for Alimera scottg@coreir.com

FAQ

What is the purpose of the Phase III clinical study for ALIM?

The study aims to support marketing approval for fluocinolone acetonide intravitreal implant in treating diabetic macular edema in China.

What approval did Ocumension receive related to ALIM?

Ocumension received approval from the National Medical Products Administration for its IND application to begin the Phase III clinical study.

What are the potential market implications of the IND approval for ALIM?

The IND approval may lead to marketing authorization in China, expanding Alimera's product reach and potential revenues.

How does the Phase III study relate to existing ALIM treatments?

The Phase III study is designed to support a future NDA filing for an indication equivalent to Alimera's current U.S. treatment for diabetic macular edema.