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Phenylephrine 10% Eyedrop
Phenylephrine 10% Eyedrop is a Small molecule drug developed by Eyenovia Inc.. It is currently in Phase 2 development.
Phenylephrine 10% Eyedrop is used to treat conditions such as Corneal Endothelial Cell Loss, Mydriasis, Cataract, Macular Edema, and Cystoid Macular Edema. It works by causing mydriasis, which is the dilation of the pupils, likely through its action as an alpha-1 adrenergic receptor agonist, as indicated by its entry in ChEMBL.
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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 10% Eyedrop |
|---|---|
| Sponsor | Eyenovia Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Effectiveness of Periocular Drug Injection in CATaract Surgery (PHASE3)
- Efficacy Mydrane ® for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma. (NA)
- Study of the Safety, Efficacy and PK of EYN-1601 in Dilation of the Pupil (PHASE2)
- Comparison Mydriasis by Mydrane With Topical Drop Application (PHASE4)
- The Pathophysiology of Orthostatic Hypotension (PHASE1)
- Implantable Phakic Lens (IPCL) VS Implantable Collamer Lens (NA)
- Effect of Intracameral Injection of Mydriatic Plus Anaesthetic Combination on Corneal Endothelial Count in Phaco (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 10% Eyedrop CI brief — competitive landscape report
- Phenylephrine 10% Eyedrop updates RSS · CI watch RSS
- Eyenovia Inc. portfolio CI
Frequently asked questions about Phenylephrine 10% Eyedrop
What is Phenylephrine 10% Eyedrop?
Who makes Phenylephrine 10% Eyedrop?
What development phase is Phenylephrine 10% Eyedrop in?
Related
- Manufacturer: Eyenovia Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing