Last reviewed · How we verify
Citicoline eye drops 2%
Citicoline eye drops 2% is a Neuroprotective agent / Membrane repair agent Small molecule drug developed by Omikron Italia S.r.l.. It is currently in Phase 3 development for Dry eye disease, Corneal dystrophy, Retinal degenerative diseases.
Citicoline is a naturally occurring compound that enhances cell membrane phospholipid synthesis and promotes neuronal membrane repair and protection in ocular tissues.
Citicoline eye drops 2% is a small molecule intervention used in clinical trials for conditions such as cornea, neurodegenerative diseases, glaucoma, and open-angle glaucoma. Citicoline, also known as CDP-choline, is a compound that has been studied for its potential therapeutic effects in various conditions, including those related to the cornea and nervous system.
-
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).
| 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 name | Citicoline eye drops 2% |
|---|---|
| Sponsor | Omikron Italia S.r.l. |
| Drug class | Neuroprotective agent / Membrane repair agent |
| Target | Phospholipid synthesis pathway (CDP-choline pathway) |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Citicoline (cytidine 5'-diphosphocholine) is a precursor to phosphatidylcholine, a major component of cell membranes. When applied topically as eye drops, it penetrates ocular tissues and supports the synthesis and repair of damaged cell membranes, particularly in retinal and corneal cells. This mechanism helps restore cellular function and protect against degenerative processes in the eye.
Approved indications
- Dry eye disease
- Corneal dystrophy
- Retinal degenerative diseases
- Post-operative corneal healing
Common side effects
- Ocular irritation
- Conjunctival hyperemia
- Transient blurred vision
Key clinical trials
- Efficacy of Citicoline Eye Drops 2% on Visual Field Preservation in Patients With Open Angle Glaucoma (PHASE3)
- Citicoline Concentration in Human Vitreous (NA)
- Evaluation of the Efficacy of OMK2 in Recovering Corneal Neural Damage in Patients With Diabetes (NA)
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:
- Citicoline eye drops 2% CI brief — competitive landscape report
- Citicoline eye drops 2% updates RSS · CI watch RSS
- Omikron Italia S.r.l. portfolio CI
Frequently asked questions about Citicoline eye drops 2%
What is Citicoline eye drops 2%?
How does Citicoline eye drops 2% work?
What is Citicoline eye drops 2% used for?
Who makes Citicoline eye drops 2%?
What drug class is Citicoline eye drops 2% in?
What development phase is Citicoline eye drops 2% in?
What are the side effects of Citicoline eye drops 2%?
What does Citicoline eye drops 2% target?
Related
- Drug class: All Neuroprotective agent / Membrane repair agent drugs
- Target: All drugs targeting Phospholipid synthesis pathway (CDP-choline pathway)
- Manufacturer: Omikron Italia S.r.l. — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Dry eye disease
- Indication: Drugs for Corneal dystrophy
- Indication: Drugs for Retinal degenerative diseases
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing