Synalar

(Fluocinolone Acetonide)

ApprovedSmall molecule

EEurofarma Laboratorios S.A.

Synalar is one of 126 small molecule programs targeting Panuveitis. It is currently in Approved.

Indications

Total Trials

Active Trials

125

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

PanuveitisActive, not recruiting

RetinopathyActive, not recruiting

Diabetic Macular EdemaActive, not recruiting

Geographic AtrophyActive, not recruiting

UveitisActive, not recruiting

PanuveitisPhase 1

Active, not recruiting

RetinopathyPhase 3

Active, not recruiting

Diabetic Macular EdemaPhase 3

Active, not recruiting

Geographic AtrophyPhase 2

Active, not recruiting

UveitisApproved

Active, not recruiting

Competition

Competitive Landscape

180 competitors in Diabetic Macular Edema

#DrugCompanyPhaseTrials

Eylea

Regeneron

Phase 3

54 2

Lucentis

Roche

Phase 3

59 3

Synalar

EEurofarma Laboratorios S.A.

Approved

4 4

Avastin

BBio-Thera Solutions

Phase 3

23 5

Beovu

Novartis

Phase 3

6 6

Kenalog

BBausch Health Americas, Inc.

Phase 3

14 7

Lucentis

Novartis

Phase 3

8 8

Luye Pharma Conbercept

CChengdu Kanghong Biotech Co., Ltd.

Phase 3

3 9

Intravitreal Ranibizumab

Roche

Phase 3

4 10

Glucophage

EMD Serono

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2028

Post-ApprovalRecruiting

Uveitis

NCT06539481

Q4 2029

Phase 3Recruiting

Retinopathy

NCT05844982

Clinical

Trials by Indication[1]

Diabetic Macular Edema4 trials

Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study

Completed·AAlimera Sciences·Phase 3·NCT01304706·120 enrolled

Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema

Completed·AAlimera Sciences·Phase 3·NCT00490815·37 enrolled

Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema

Completed·AAlimera Sciences·Phase 3·NCT00344968·956 enrolled

Show 1 more trial

Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

Completed·BBausch & Lomb Incorporated·Phase 2/3·NCT00502541·196 enrolled

Uveitis2 trials

Open Label Trial Studying the Safety and Effectiveness of ILUVIEN® (190μg) in Children and Adolescents, Who Have Recurrent Non-infectious Uveitis Affecting the Posterior Segment of the Eye.

Recruiting·AAlimera Sciences·Phase 4·NCT06539481·25 enrolled

Imaging of Uveitis Patients Receiving Injectable Fluocinolone Acetonide Implant

Completed·TThe Cleveland Clinic··NCT04340505·30 enrolled

Safety and Efficacy2 trials

Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant

Terminated·BBausch & Lomb Incorporated·Phase 2/3·NCT00456482·239 enrolled

Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

Completed·BBausch & Lomb Incorporated·Phase 2/3·NCT00407082·278 enrolled

Retinopathy2 trials

Steroids for Early Treatment of Radiation Retinopathy

Withdrawn·TThe Cleveland Clinic·Phase 2/3·NCT03238157

Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy

Recruiting·JJaeb Center for Health Research·Phase 3·NCT05844982·600 enrolled

Occlusion1 trial

Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina

Terminated·AAlimera Sciences·Phase 2·NCT00770770·20 enrolled

2 more indications

Panuveitis1 trial

Pilot Study of a Fluocinolone Acetonide Intravitreal Insert (FA-i) to Treat Intermediate-, Posterior-, or Panuveitis

Completed·GGlenn Jaffe·Phase 1·NCT01781936·17 enrolled

Geographic Atrophy1 trial

Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy

Terminated·AAlimera Sciences·Phase 2·NCT00695318·17 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

SYNALAR

NDA NDA015296

Jan 1, 1982

SYNALAR-HP

NDA NDA016161

Jan 1, 1982

SYNALAR

NDA NDA013960

Jan 1, 1982

SYNALAR

NDA NDA012787

Aug 27, 1990

CAPEX

NDA NDA020001

Apr 8, 2005

RETISERT

NDA NDA021737

Nov 9, 2005

DERMOTIC

NDA NDA019452

Sep 26, 2014

ILUVIEN

NDA NDA201923

Oct 12, 2018

YUTIQ

NDA NDA210331

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Fluocinolone Acetonide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fluocinolone Acetonide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fluocinolone Acetonide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA210331). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Synalar. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Eurofarma Laboratorios S.A. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: EEurofarma Laboratorios S.A.

Patent Landscape[5]

Patent Cliff

Aug 12, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8871241Aug 12, 2027

7998108Jan 12, 2028

9849027Nov 7, 2028

Synalar

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2028

Q4 2029

Trials by Indication[1]

Diabetic Macular Edema4 trials

Uveitis2 trials

Safety and Efficacy2 trials

Retinopathy2 trials

Occlusion1 trial

Panuveitis1 trial

Geographic Atrophy1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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