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Prednisolone acetate1%,
Prednisolone acetate1%, is a Small molecule drug developed by Aravind Eye Care System. It is currently in Phase 1 development. Also known as: pred forte (Prednisolone acetate1% ).
Prednisolone acetate 1% is a topical ophthalmic suspension used to treat conditions such as non-infectious anterior uveitis. It works as a glucocorticoid receptor agonist, a type of small molecule that activates the glucocorticoid receptor.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Prednisolone acetate1%, |
|---|---|
| Also known as | pred forte (Prednisolone acetate1% ) |
| Sponsor | Aravind Eye Care System |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Loteprednol Etabonate Versus Prednisolone Acetate for Anterior Chamber Granulomas (PHASE4)
- Dextenza Versus Topical Steroid Eye Drops for Postoperative Management Following Corneal Crosslinking (PHASE1, PHASE2)
- Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes (PHASE4)
- Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery (PHASE4)
- ACP Max™ PRP System for Knee Osteoarthritis: A Feasibility Trial (NA)
- Dextenza in the Post-op Management of Vitreoretinal Surgeries (PHASE4)
- The TRIBECA Study (TRIessence/Byqlovi for Easier CAtaract Surgery) (PHASE4)
- In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery (PHASE4)
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:
- Prednisolone acetate1%, CI brief — competitive landscape report
- Prednisolone acetate1%, updates RSS · CI watch RSS
- Aravind Eye Care System portfolio CI
Frequently asked questions about Prednisolone acetate1%,
What is Prednisolone acetate1%,?
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Related
- Manufacturer: Aravind Eye Care System — full pipeline
- Also known as: pred forte (Prednisolone acetate1% )
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing