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KPI-121 1.0%
KPI-121 1.0% is a Topical corticosteroid Small molecule drug developed by Kala Pharmaceuticals, Inc.. It is currently in Phase 3 development for Dry eye disease, Post-operative ocular inflammation. Also known as: KPI-121 1.0% Ophthalmic Suspension, Loteprednol etabonate 1.0%.
KPI-121 is a topical ophthalmic formulation that reduces ocular surface inflammation and promotes tear film stability through a mucoadhesive delivery system.
KPI-121 is a topical ophthalmic formulation that reduces ocular surface inflammation and promotes tear film stability through a mucoadhesive delivery system. Used for Dry eye disease, Post-operative ocular inflammation.
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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 | KPI-121 1.0% |
|---|---|
| Also known as | KPI-121 1.0% Ophthalmic Suspension, Loteprednol etabonate 1.0% |
| Sponsor | Kala Pharmaceuticals, Inc. |
| Drug class | Topical corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
KPI-121 is a 1.0% formulation of difluprednate, a potent corticosteroid, delivered via Kala's proprietary mucoadhesive technology (AMPPLIFY) that enhances corneal and conjunctival penetration while prolonging ocular residence time. This allows for reduced dosing frequency while maintaining anti-inflammatory efficacy for dry eye disease and post-operative inflammation.
Approved indications
- Dry eye disease
- Post-operative ocular inflammation
Common side effects
- Ocular irritation
- Conjunctival hyperemia
- Eye discomfort
- Increased intraocular pressure
Key clinical trials
- Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation (PHASE3)
- Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain (PHASE3)
- Exploratory Study of KPI-121 Effect on Intra- or Subretinal Fluid Due to Retinal Vein Occlusion/Diabetic Macular Edema (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:
- KPI-121 1.0% CI brief — competitive landscape report
- KPI-121 1.0% updates RSS · CI watch RSS
- Kala Pharmaceuticals, Inc. portfolio CI
Frequently asked questions about KPI-121 1.0%
What is KPI-121 1.0%?
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Is KPI-121 1.0% also known as anything else?
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Related
- Drug class: All Topical corticosteroid drugs
- Target: All drugs targeting Glucocorticoid receptor
- Manufacturer: Kala Pharmaceuticals, Inc. — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Dry eye disease
- Indication: Drugs for Post-operative ocular inflammation
- Also known as: KPI-121 1.0% Ophthalmic Suspension, Loteprednol etabonate 1.0%
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing