Ilevro

(Nepafenac)

ApprovedSmall molecule

HHarrow Inc

Ilevro is one of 89 small molecule programs targeting Cystoid Macular Edema. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Cystoid Macular EdemaActive, not recruiting

CataractActive, not recruiting

UveitisActive, not recruiting

Cystoid Macular EdemaApproved

Active, not recruiting

CataractApproved

Active, not recruiting

UveitisApproved

Active, not recruiting

Competition

Competitive Landscape

219 competitors in Cataract

#DrugCompanyPhaseTrials

Pred Forte

Novartis

Phase 3

6 2

Ilevro

HHarrow Inc

Approved

5 3

Lotemax

BBausch & Lomb Incorporated

Phase 3

7 4

Aquasol E

NNational Eye Institute (NEI)

Phase 3

—5

KPI-121

KKala Pharmaceuticals, Inc.

Phase 3

1 6

Zolymbus

AbbVie

Preclinical

—7

Neurontin

VViatris Specialty LLC

Preclinical

3 8

Kenalog

BBassett Healthcare

Preclinical

1 9

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 10

Duragesic

CCephalon

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Cystoid Macular Edema

NCT05072262

Clinical

Trials by Indication[1]

Cataract5 trials

Effect of Nepafenac on Post-operative Macular Swelling Following Uncomplicated Cataract Surgery

Completed·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT00494494·82 enrolled

Therapeutic Variables in Cataract Surgery

Completed·IInnovative Medical·Phase 4·NCT00407017

Study Title: Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD With Extra (Pulse) Dose on Day of Surgery for Treatment of Ocular Inflammation Associated With Cataract Surgery in a Randomized, Single Masked Clinical Trial

Completed·SSilverstein Eye Centers·Phase 4·NCT03886779·57 enrolled

Show 2 more trials

Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis During Cataract Surgery

Unknown status·—·Phase 2·NCT03851172·75 enrolled

Cataract Surgery and Inflammation - the Role for Preoperative NSAIDs (Pre-CIN)

Unknown status·OOslo University Hospital·Phase 4·NCT05331690·500 enrolled

Cystoid Macular Edema2 trials

Anti-inflammatory Efficacy for Prophylaxis of Cystoid Macular Edema (CME) After Phacoemulsification

Completed·—·Phase 4·NCT02084576·40 enrolled

DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)

Recruiting·OOslo University Hospital·Phase 4·NCT05072262·300 enrolled

Diclofenac1 trial

Comparison of Diclofenac vs. Nepafenac Ophthalmic Drops: Patient Comfort

Unknown status·WWolfson Medical Center·N/A·NCT02506348·30 enrolled

Ketorolac1 trial

A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification

Completed·FFrank A. Bucci, Jr., M.D.·Phase 4·NCT01021761·126 enrolled

Macular Edema1 trial

Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

Completed·HHospital Juarez de Mexico·Phase 2·NCT00900887·84 enrolled

6 more indications

Uveitis1 trial

Macular Edema Nepafenac vs. Difluprednate Uveitis Trial

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

NAC1 trial

Comparison of Vitreous Levels of Acular LS 0.04%, Xibrom 0.09%, and Nevanac 0.1%

Completed·IInnovative Medical·Phase 4·NCT00377546

Intraocular Pressure1 trial

Effect of Nepafenac Eye Drops on Intraocular Pressure in Normal Eyes

Completed·DDr T V Patel Eye Institute·Phase 4·NCT01995890·327 enrolled

Outcome1 trial

Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1%

Completed·TToyos Clinic·Phase 4·NCT01310127·23 enrolled

Coagulation1 trial

Effect of Topical Nepafenac in Macular Thickening Related to Pan-retinal Photocoagulation

Terminated·AAsociación para Evitar la Ceguera en México·Phase 2·NCT00801905·50 enrolled

Pain Control1 trial

Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK

Completed·CCenter For Excellence In Eye Care·Phase 4·NCT00347204·40 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 19, 2005

NEVANAC

NDA NDA021862

Oct 16, 2012

ILEVRO

NDA NDA203491

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Nepafenac. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Nepafenac compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Nepafenac. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA203491). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Ilevro. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Harrow Inc company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: HHarrow Inc

Patent Landscape[5]

Patent Cliff

Jan 31, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7834059Jan 31, 2027

9662398Dec 1, 2030

8921337Mar 31, 2032

Ilevro

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Cataract5 trials

Cystoid Macular Edema2 trials

Diclofenac1 trial

Ketorolac1 trial

Macular Edema1 trial

Uveitis1 trial

NAC1 trial

Intraocular Pressure1 trial

Outcome1 trial

Coagulation1 trial

Pain Control1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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