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Tiespectus
Tiespectus is a Small molecule drug developed by EyeBiotech Ltd.. It is currently in Phase 2 development. Also known as: EYE201, MK-8748.
Tiespectus is being studied in clinical trials for conditions such as Macular Degeneration, Age-Related Macular Degeneration, Choroidal Neovascularization, Wet Macular Degeneration, and Diabetic Macular Edema (DME). It is being compared to Aflibercept and EYE201 in a randomized double-masked, multicenter, 3-arm, pivotal Phase 2/3 study.
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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 | Tiespectus |
|---|---|
| Also known as | EYE201, MK-8748 |
| Sponsor | EyeBiotech Ltd. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-003) (PHASE2, PHASE3)
- A 2-part Study Consisting of a Multiple Ascending Dose Safety Study in Participants With Macular Edema Following Branch Retinal Vein Occlusion and a Dose-finding Safety and Preliminary Efficacy Study in Participants With Either Diabetic Macular Edema or Neovascular Age-related Macular Degeneration (PHASE1, PHASE2)
- A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002) (PHASE2, 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:
- Tiespectus CI brief — competitive landscape report
- Tiespectus updates RSS · CI watch RSS
- EyeBiotech Ltd. portfolio CI
Frequently asked questions about Tiespectus
What is Tiespectus?
Who makes Tiespectus?
Is Tiespectus also known as anything else?
What development phase is Tiespectus in?
Related
- Manufacturer: EyeBiotech Ltd. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: EYE201, MK-8748
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing