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PRFM treatment

The New York Eye & Ear Infirmary · Phase 3 active Biologic

PRFM treatment is a Regenerative medicine / Autologous cell therapy Biologic drug developed by The New York Eye & Ear Infirmary. It is currently in Phase 3 development for Corneal epithelial defects and ocular surface disease.

PRFM (platelet-rich fibrin matrix) treatment uses autologous platelet-derived growth factors and fibrin scaffolding to promote tissue regeneration and healing.

PRFM (platelet-rich fibrin matrix) treatment uses autologous platelet-derived growth factors and fibrin scaffolding to promote tissue regeneration and healing. Used for Corneal epithelial defects and ocular surface disease.

Likelihood of approval
58.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2028–2030
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic namePRFM treatment
SponsorThe New York Eye & Ear Infirmary
Drug classRegenerative medicine / Autologous cell therapy
ModalityBiologic
Therapeutic areaOphthalmology / Regenerative Medicine
PhasePhase 3

Mechanism of action

PRFM is a regenerative medicine approach that concentrates platelets and fibrin from the patient's own blood to create a bioactive matrix. This matrix releases growth factors (PDGF, VEGF, FGF, TGF-β) that stimulate angiogenesis, cell proliferation, and tissue remodeling. The fibrin scaffold provides structural support for new tissue formation and is gradually resorbed as healing progresses.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about PRFM treatment

What is PRFM treatment?

PRFM treatment is a Regenerative medicine / Autologous cell therapy drug developed by The New York Eye & Ear Infirmary, indicated for Corneal epithelial defects and ocular surface disease.

How does PRFM treatment work?

PRFM (platelet-rich fibrin matrix) treatment uses autologous platelet-derived growth factors and fibrin scaffolding to promote tissue regeneration and healing.

What is PRFM treatment used for?

PRFM treatment is indicated for Corneal epithelial defects and ocular surface disease.

Who makes PRFM treatment?

PRFM treatment is developed by The New York Eye & Ear Infirmary (see full The New York Eye & Ear Infirmary pipeline at /company/the-new-york-eye-ear-infirmary).

What drug class is PRFM treatment in?

PRFM treatment belongs to the Regenerative medicine / Autologous cell therapy class. See all Regenerative medicine / Autologous cell therapy drugs at /class/regenerative-medicine-autologous-cell-therapy.

What development phase is PRFM treatment in?

PRFM treatment is in Phase 3.

What are the side effects of PRFM treatment?

Common side effects of PRFM treatment include Infection at application site, Inflammation, Delayed healing.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing