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SkQ1 Ophthalmic Solution
SkQ1 Ophthalmic Solution is a Mitochondrially-targeted antioxidant Small molecule drug developed by Mitotech, SA. It is currently in Phase 3 development for Treatment of dry age-related macular degeneration. Also known as: Visomitin.
SkQ1 Ophthalmic Solution is a mitochondrially-targeted antioxidant that aims to protect retinal cells from oxidative stress.
SkQ1 Ophthalmic Solution is being studied as a potential treatment for Dry Eye Syndrome and Keratoconjunctivitis Sicca in clinical trials. SkQ1 is an oligosaccharide modality, according to ChEMBL, which is being investigated in various doses in these trials.
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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 | SkQ1 Ophthalmic Solution |
|---|---|
| Also known as | Visomitin |
| Sponsor | Mitotech, SA |
| Drug class | Mitochondrially-targeted antioxidant |
| Target | Mitochondrial electron transport chain |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
SkQ1 works by accumulating in the mitochondria of retinal cells, where it scavenges reactive oxygen species and reduces oxidative damage. This is thought to slow the progression of age-related macular degeneration and other retinal diseases.
Approved indications
- Treatment of dry age-related macular degeneration
Common side effects
- Eye irritation
Key clinical trials
- Study of SkQ1 as Treatment for Dry-eye Syndrome (PHASE3)
- Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome (PHASE3)
- A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES) (PHASE2)
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:
- SkQ1 Ophthalmic Solution CI brief — competitive landscape report
- SkQ1 Ophthalmic Solution updates RSS · CI watch RSS
- Mitotech, SA portfolio CI
Frequently asked questions about SkQ1 Ophthalmic Solution
What is SkQ1 Ophthalmic Solution?
How does SkQ1 Ophthalmic Solution work?
What is SkQ1 Ophthalmic Solution used for?
Who makes SkQ1 Ophthalmic Solution?
Is SkQ1 Ophthalmic Solution also known as anything else?
What drug class is SkQ1 Ophthalmic Solution in?
What development phase is SkQ1 Ophthalmic Solution in?
What are the side effects of SkQ1 Ophthalmic Solution?
What does SkQ1 Ophthalmic Solution target?
Related
- Drug class: All Mitochondrially-targeted antioxidant drugs
- Target: All drugs targeting Mitochondrial electron transport chain
- Manufacturer: Mitotech, SA — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Treatment of dry age-related macular degeneration
- Also known as: Visomitin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing