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APD-209 Eye drops

Adenovir Pharma AB · Phase 2 active Small molecule Under review

APD-209 Eye drops is a Small molecule drug developed by Adenovir Pharma AB. It is currently in Phase 2 development for Treatment of dry eye disease.

APD-209 Eye drops are designed to reduce inflammation in the eye by inhibiting the action of a specific enzyme.

APD-209 Eye drops are being studied for the treatment of Viral Conjunctivitis. The therapeutic efficacy of APD-209 Eye drops is being evaluated in the treatment of Epidemic Keratoconjunctivitis (EKC), a condition that is likely related to Viral Conjunctivitis.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% 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 2031–2034
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameAPD-209 Eye drops
SponsorAdenovir Pharma AB
ModalitySmall molecule
Therapeutic areaOphthalmology
PhasePhase 2

Mechanism of action

The exact mechanism of action of APD-209 Eye drops involves the inhibition of a particular enzyme that plays a key role in the inflammatory process. This inhibition leads to a reduction in the production of pro-inflammatory mediators, resulting in decreased inflammation in the eye. Further research is needed to fully understand the mechanism of action of APD-209 Eye drops.

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 APD-209 Eye drops

What is APD-209 Eye drops?

APD-209 Eye drops is a Small molecule drug developed by Adenovir Pharma AB, indicated for Treatment of dry eye disease.

How does APD-209 Eye drops work?

APD-209 Eye drops are designed to reduce inflammation in the eye by inhibiting the action of a specific enzyme.

What is APD-209 Eye drops used for?

APD-209 Eye drops is indicated for Treatment of dry eye disease.

Who makes APD-209 Eye drops?

APD-209 Eye drops is developed by Adenovir Pharma AB (see full Adenovir Pharma AB pipeline at /company/adenovir-pharma-ab).

What development phase is APD-209 Eye drops in?

APD-209 Eye drops is in Phase 2.

What are the side effects of APD-209 Eye drops?

Common side effects of APD-209 Eye drops include Eye irritation.

Related

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