Pred Forte

(Prednisolone acetate)

ApprovedSmall molecule

Prednisolone acetate is a steroid eye drop used to reduce inflammation and swelling in the eyes, often after surgery or for inflammatory eye conditions like uveitis.[2] Pred Forte is currently approved and in use across 9 indications[4].[1]

Pred Forte is one of 140 small molecule programs targeting Retinal Detachment. It is currently in Approved.

Indications

Total Trials

Active Trials

139

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Retinal DetachmentActive, not recruiting

Epiretinal MembraneActive, not recruiting

IritisActive, not recruiting

Multiple SclerosisUnknown

AnemiaUnknown

Corneal ScarringUnknown

Allergic ConjunctivitisUnknown

PneumoniaUnknown status

PterygiumCompleted

Retinal DetachmentApproved

Active, not recruiting

Epiretinal MembranePreclinical

Active, not recruiting

IritisPreclinical

Active, not recruiting

Multiple SclerosisPreclinical

Unknown

AnemiaPreclinical

Unknown

Corneal ScarringPreclinical

Unknown

Allergic ConjunctivitisPreclinical

Unknown

PneumoniaApproved

Unknown status

PterygiumApproved

Completed

Competition

Competitive Landscape

155 competitors in Pneumonia

#DrugCompanyPhaseTrials

Pred Forte

Novartis

Approved

1 2

Acanya

Pfizer

Preclinical

1 3

Prevacid

Takeda

Preclinical

1 4

Plaquenil

Jazz Pharmaceuticals

Preclinical

1 5

Innohep

Jazz Pharmaceuticals

Preclinical

1 6

Primsol

CConrado Roberto Hoffmann Filho

Preclinical

2 7

Zantac 150

CChattem

Preclinical

2 8

Retrovir

BBp Consulting, Inc

Preclinical

2 9

Mycifradin

PPharmacia and Upjohn

Preclinical

1 10

Ofev

Boehringer Ingelheim

Preclinical

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

Timeline

Expected Milestones

Q2 2027

N/ARecruiting

Refractory

NCT03415828

Clinical

Trials by Indication[1]

Cataract6 trials

Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery

Completed·BBp Consulting, Inc·Phase 4·NCT00758199·49 enrolled

KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children

Terminated·KKala Pharmaceuticals, Inc.·Phase 3·NCT03596723·2 enrolled

A Study to Compare Ocular Safety and Tolerability of Eye Drops Containing Prednisolone Acetate in Patients With Intraocular Inflammation After Cataract Surgery

Completed· Novartis logo

Novartis·Phase 4·NCT00170729·62 enrolled

Show 3 more trials

In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery

Completed·VVance Thompson Vision·Phase 4·NCT05023304·30 enrolled

Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract

Recruiting·EEyePoint Pharmaceuticals, Inc.·Phase 4·NCT05191706·60 enrolled

Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population

Recruiting·SSalvat·Phase 3·NCT05724446·60 enrolled

Prednisolone3 trials

A Study to Compare Ocular Safety and Tolerability of Prednisolone Acetate 0.5% Eye Drops Versus Vehicle in Healthy Volunteers

Completed· Novartis logo

Novartis·Phase 4·NCT00134992·30 enrolled

A Comparison of Three Different Formulations of Prednisolone Acetate 1%

Completed·IIndiana University School of Medicine·Phase 4·NCT00345046·60 enrolled

A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%

Completed·RResearch Insight LLC·Phase 4·NCT04273282·31 enrolled

Macular Edema2 trials

Nepafenac Once Daily for Macular Edema - Study 1

Completed·AAlcon Research·Phase 3·NCT01853072·881 enrolled

Nepafenac Once Daily for Macular Edema - Study 2

Completed·AAlcon Research·Phase 3·NCT01872611·819 enrolled

Anterior Uveitis2 trials

A Phase 2 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis

Completed·VVivaVision Biotech, Inc·Phase 2·NCT06679153·89 enrolled

A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis

Completed·AAldeyra Therapeutics, Inc.·Phase 2·NCT02406209·45 enrolled

Uveitis2 trials

Study of Difluprednate in the Treatment of Uveitis

Completed·SSirion Therapeutics, Inc.·Phase 3·NCT00501579

Macular Edema Nepafenac vs. Difluprednate Uveitis Trial

Terminated·UUniversity of California, San Francisco·Phase 4·NCT01939691·9 enrolled

17 more indications

Epiretinal membrane1 trial

Topical Use of Corticosteroid to Prevent Epiretinal Membrane Following Retinal Tear

Completed·UUnity Health Toronto·N/A·NCT02412059·200 enrolled

Retinal Vein Occlusion1 trial

To Study the Effectiveness and Safety of Niacin and a Topical Steroid Eye Drop to Treat Retinal Vein Occlusions

Completed·PPalo Alto Medical Foundation·Phase 2/3·NCT00493064·63 enrolled

Refractory1 trial

Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

Recruiting·GGelscom SAS·N/A·NCT03415828·230 enrolled

Inflammation1 trial

Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections

Terminated·RRetina Vitreous Associates of Florida·Phase 4·NCT04563299·10 enrolled

Recovery1 trial

Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing FLACS With Premium IOL

Unknown status·SSight Medical Doctors PLLC·Phase 4·NCT04863742·30 enrolled

Prostate Cancer1 trial

The Efficacy and Safety of Docetaxel Combined With Platinum for Metastatic Hormone-sensitive Prostate Cancer

Unknown status·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 2·NCT05461261·50 enrolled

Pterygium1 trial

Dextenza for Post-operative Treatment of Pterygium

Completed·BBrandon Eye Associates, PA·Phase 4·NCT04351737·20 enrolled

Rejection1 trial

Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)

Completed·PPrice Vision Group·Phase 2·NCT01448213·264 enrolled

Pneumonia1 trial

Research on the Treatment of Severe Community-acquired Pneumonia in Children

Unknown status·BBaoping XU·Phase 4·NCT05768204·160 enrolled

Ketorolac1 trial

Efficacy of Topical Ketorolac Versus Placebo for Improving Visual Outcomes Following Multifocal IOL Implantation

Completed·IInnovative Medical·Phase 4·NCT00433225

Sciatica1 trial

Efficacy of corticoïd Infiltration Via Sacro-coccygien Hiatus in Discal Sciatica

Terminated·NNantes University Hospital·Phase 3·NCT01482897·13 enrolled

ESS1 trial

Assessing Dextenza Insert After SMILE Procedure

Completed·WWilliam Wiley, MD·Phase 4·NCT04380857·20 enrolled

Non-Infectious Anterior Uveitis1 trial

Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis

Completed·EEyegate Pharmaceuticals, Inc.·Phase 3·NCT02517619·251 enrolled

Diabetic Retinopathy1 trial

A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients

Completed·AAlcon Research·Phase 2·NCT00782717·263 enrolled

Retinal Detachment1 trial

Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment

Terminated·MMidwest Eye Institute·Phase 4·NCT04464629·7 enrolled

Dexamethasone1 trial

Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study

Completed·SSight Medical Doctors PLLC·Phase 4·NCT04168112·20 enrolled

Unspecified1 trial

Use of Topical Euphrasia, a Homeopathic Remedy in Ophthalmology

Withdrawn·LLarkin Community Hospital·N/A·NCT02416128

Regulatory

FDA Approval Timeline[5]

Nov 26, 1974

PRED FORTE

NDA NDA017011

Aug 5, 1975

PRED FORTE

NDA NDA017011

Nov 19, 1979

PRED FORTE

NDA NDA017011

Jan 22, 1980

PRED FORTE

NDA NDA017011

Aug 13, 1982

PRED FORTE

NDA NDA017011

Sep 2, 1982

PRED FORTE

NDA NDA017011

Sep 3, 1982

PRED FORTE

NDA NDA017011

Jul 11, 1983

PRED FORTE

NDA NDA017011

Apr 15, 1986

PRED FORTE

NDA NDA017011

Jun 13, 1986

PRED FORTE

NDA NDA017011

Jun 13, 1986

PRED FORTE

NDA NDA017011

Apr 30, 1987

PRED FORTE

NDA NDA017011

Nov 3, 1987

PRED FORTE

NDA NDA017011

Feb 17, 1988

PRED FORTE

NDA NDA017011

Sep 9, 1988

PRED FORTE

NDA NDA017011

Oct 12, 1989

PRED FORTE

NDA NDA017011

Oct 30, 1989

PRED FORTE

NDA NDA017011

May 10, 1995

PRED FORTE

NDA NDA017011

Aug 3, 1995

PRED FORTE

NDA NDA017011

Dec 5, 1996

PRED FORTE

NDA NDA017011

Sep 30, 1997

PRED FORTE

NDA NDA017011

May 19, 1998

PRED FORTE

NDA NDA017011

Oct 2, 2000

PRED FORTE

NDA NDA017011

Apr 12, 2001

PRED FORTE

NDA NDA017011

Jul 24, 2001

PRED FORTE

NDA NDA017011

Sep 28, 2001

PRED FORTE

NDA NDA017011

Dec 4, 2001

PRED FORTE

NDA NDA017011

Apr 12, 2002

PRED FORTE

NDA NDA017011

May 4, 2017

PRED FORTE

NDA NDA017011

Jun 6, 2018

PRED FORTE

NDA NDA017011

Sources

References

[1]
ClinicalTrials.gov — 32 trial records for Prednisolone acetate. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Pred Forte drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Prednisolone acetate compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Prednisolone acetate. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA017011). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Glucocorticoid Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

Pred Forte

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Trials by Indication[1]

Cataract6 trials

Prednisolone3 trials

Macular Edema2 trials

Anterior Uveitis2 trials

Uveitis2 trials

Epiretinal membrane1 trial

Retinal Vein Occlusion1 trial

Refractory1 trial

Inflammation1 trial

Recovery1 trial

Prostate Cancer1 trial

Pterygium1 trial

Rejection1 trial

Pneumonia1 trial

Ketorolac1 trial

Sciatica1 trial

ESS1 trial

Non-Infectious Anterior Uveitis1 trial

Diabetic Retinopathy1 trial

Retinal Detachment1 trial

Dexamethasone1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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