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Eyepoint Pharmaceuticals (EYPT) FDA Approvals

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Eyepoint Pharmaceuticals' Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Eyepoint Pharmaceuticals (EYPT). Over the past two years, Eyepoint Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as DURAVYU and EYP-1901. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

DURAVYU FDA Regulatory Timeline and Events

DURAVYU is a drug developed by Eyepoint Pharmaceuticals for the following indication: In patients with non-proliferative diabetic retinopathy (NPDR). 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.

EYP-1901 FDA Regulatory Events

EYP-1901 is a drug developed by Eyepoint Pharmaceuticals for the following indication: Wet age-related macular degeneration (AMD). 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.

Eyepoint Pharmaceuticals FDA Events - Frequently Asked Questions

In the past two years, Eyepoint Pharmaceuticals (EYPT) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, Eyepoint Pharmaceuticals (EYPT) has reported FDA regulatory activity for the following drugs: DURAVYU and EYP-1901.

The most recent FDA-related event for Eyepoint Pharmaceuticals occurred on July 29, 2025, involving DURAVYU. The update was categorized as "Enrollment Update," with the company reporting: "EyePoint Pharmaceuticals, Inc. announced it has completed enrollment of its Phase 3 pivotal program with the full enrollment of the LUCIA trial, the second of two identical ongoing pivotal non-inferiority trials evaluating DURAVYU™ for the treatment of wet age-related macular degeneration (wet AMD). The first pivotal trial, LUGANO, completed enrollment in May 2025."

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

  • In patients with non-proliferative diabetic retinopathy (NPDR). - DURAVYU
  • Wet age-related macular degeneration (AMD) - EYP-1901

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:EYPT) was last updated on 8/2/2025 by MarketBeat.com Staff
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