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Harrow (HROW) FDA Events

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FDA Events for Harrow (HROW)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Harrow (HROW). Over the past two years, Harrow has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as IHEEZO, TRIESENCE®, and VEVYE. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Harrow's Drugs in FDA Review

IHEEZO - FDA Regulatory Timeline and Events

IHEEZO is a drug developed by Harrow for the following indication: Chloroprocaine hydrochloride ophthalmic gel. 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.

TRIESENCE® - FDA Regulatory Timeline and Events

TRIESENCE® is a drug developed by Harrow for the following indication: For the treatment of sympathetic ophthalmia, temporal arteritis, uveitis. 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.

VEVYE - FDA Regulatory Timeline and Events

VEVYE is a drug developed by Harrow for the following indication: For treating both the signs and symptoms of dry eye disease (DED). 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.

Harrow FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Harrow (HROW) has reported FDA regulatory activity for the following drugs: VEVYE, TRIESENCE® and IHEEZO.

The most recent FDA-related event for Harrow occurred on April 10, 2025, involving VEVYE. The update was categorized as "Provided Update," with the company reporting: "Harrow announced an expansion of its VEVYE® Access for All("VAFA") program to include patients currently prescribed Klarity-C Drops®, a compounded cyclosporine 0.1% product manufactured and distributed by ImprimisRx®, Harrow's compounding subsidiary."

Current therapies from Harrow in review with the FDA target conditions such as:

  • For treating both the signs and symptoms of dry eye disease (DED). - VEVYE
  • For the treatment of sympathetic ophthalmia, temporal arteritis, uveitis - TRIESENCE®
  • Chloroprocaine hydrochloride ophthalmic gel - IHEEZO

More FDA Event Resources from MarketBeat

  • 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:HROW) was last updated on 7/10/2025 by MarketBeat.com Staff
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