Alimera Sciences' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Alimera Sciences (ALIM).
Over the past two years, Alimera Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ILUVIEN®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ILUVIEN® FDA Regulatory Events
ILUVIEN® is a drug developed by Alimera Sciences for the following indication: For patients with diabetic macular edema.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ILUVIEN®
- Announced Date:
- July 23, 2025
- Indication:
- For patients with diabetic macular edema
Announcement
ANI Pharmaceuticals, Inc. announced results from the NEW DAY clinical trial of ILUVIEN® (fluocinolone acetonide intravitreal implant), 0.19 mg (ILUVIEN) for use in patients with diabetic macular edema (DME).
AI Summary
At the ASRS meeting, ANI Pharmaceuticals presented results from the NEW DAY trial in over 300 DME patients. The primary endpoint measured mean supplemental aflibercept injections over 18 months: ILUVIEN patients needed 2.4 injections versus 2.5 for aflibercept (p=0.756), missing significance.
The time to first supplemental injection was significantly longer with ILUVIEN (185.4 days vs. 132.8 days, p<0.001). In post-hoc analysis of a strict protocol subgroup, ILUVIEN required fewer supplemental injections (1.8 vs. 2.5, p=0.029). Thirty-three percent of ILUVIEN patients avoided extra injections, compared to 30 percent in the aflibercept arm.
Dr. Singer noted DME’s multifactorial nature and highlighted ILUVIEN’s potential to reduce treatment visits. The implant’s safety profile was consistent with earlier studies, with expected cataract and intraocular pressure increases. ANI’s CEO said these data may support earlier ILUVIEN use to lower treatment burden in diabetic macular edema.
Read Announcement- Drug:
- ILUVIEN®
- Announced Date:
- March 14, 2025
- Indication:
- For patients with diabetic macular edema
Announcement
ANI Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for ILUVIEN (fluocinolone acetonide intravitreal implant) that includes an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS).
AI Summary
ANI Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for ILUVIEN (fluocinolone acetonide intravitreal implant). This new approval includes a treatment indication for chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS), in addition to its existing use for diabetic macular edema (DME). With this label expansion, ILUVIEN now offers an additional, long-acting treatment option for patients suffering from NIU-PS. ANI plans to begin marketing the product in the United States under the combined indications later this year. The updated label also features revisions in the warnings and precautions sections to guide safe administration. This decision by the FDA strengthens the treatment options available for patients with these chronic eye conditions while expanding the clinical reach of ILUVIEN in the U.S. market.
Read Announcement
Alimera Sciences FDA Events - Frequently Asked Questions
As of now, Alimera Sciences (ALIM) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Alimera Sciences (ALIM) has reported FDA regulatory activity for ILUVIEN®.
The most recent FDA-related event for Alimera Sciences occurred on July 23, 2025, involving ILUVIEN®. The update was categorized as "Results," with the company reporting: "ANI Pharmaceuticals, Inc. announced results from the NEW DAY clinical trial of ILUVIEN® (fluocinolone acetonide intravitreal implant), 0.19 mg (ILUVIEN) for use in patients with diabetic macular edema (DME)."
Currently, Alimera Sciences has one therapy (ILUVIEN®) targeting the following condition: For patients with diabetic macular edema.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:ALIM) was last updated on 8/2/2025 by MarketBeat.com Staff
