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Phenylephrine 2.5% Eyedrop
Phenylephrine 2.5% Eyedrop is a Small molecule drug developed by Eyenovia Inc.. It is currently in Phase 2 development.
Phenylephrine 2.5% Eyedrop is used to treat conditions such as ptosis and mydriasis. It is an alpha-adrenergic agonist, as indicated by its listing in ChEMBL, which suggests its mechanism of action.
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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).
| 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 name | Phenylephrine 2.5% Eyedrop |
|---|---|
| Sponsor | Eyenovia Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Phenylephrine Versus Eyelid Taping for Muller's Muscle-Conjunctival Resection (MMCR) Evaluation (PHASE4)
- Pharmacodynamics of a Fixed Dose Combination of 0.34% Tropicamide and 2.5% Phenylephrine Hydrochloride, Eye Drop, Solution (PHASE1, PHASE2)
- Contribution of the Kinematic Theory in the Early Differential Diagnosis of the Parkinson's Disease
- Safety and Efficacy of Fixed Combination Phenylephrine-Tropicamide for Pupil Dilation (PHASE4)
- The Effects of Mydriatic Eye Drops in Retinopathy of Prematurity Examinations
- Study of the Safety, Efficacy and PK of EYN-1601 in Dilation of the Pupil (PHASE2)
- Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation (PHASE3)
- Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial 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:
- Phenylephrine 2.5% Eyedrop CI brief — competitive landscape report
- Phenylephrine 2.5% Eyedrop updates RSS · CI watch RSS
- Eyenovia Inc. portfolio CI
Frequently asked questions about Phenylephrine 2.5% Eyedrop
What is Phenylephrine 2.5% Eyedrop?
Who makes Phenylephrine 2.5% Eyedrop?
What development phase is Phenylephrine 2.5% Eyedrop in?
Related
- Manufacturer: Eyenovia Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing