Last reviewed 2026-04-23 · How we verify

KPI-121 0.25%

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, Ocular surface inflammation.

At a glance

Mechanism of action

KPI-121 is a 0.25% ophthalmic suspension designed to deliver anti-inflammatory and lubricating agents directly to the ocular surface with enhanced residence time. The formulation uses Kala's proprietary mucoadhesive technology to maintain prolonged contact with the eye, improving therapeutic efficacy for dry eye disease and related inflammatory conditions.

Approved indications

• Dry eye disease
• Ocular surface inflammation

Common side effects

• Instillation site irritation
• Conjunctival hyperemia
• Eye discomfort

Key clinical trials

• Safety and Efficacy of KPI-121 in Subjects With DED (PHASE3)
• Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease (PHASE3)
• Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation (PHASE3)
• Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease (PHASE2)
• Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease (PHASE2)
• Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease (PHASE3)
• Exploratory Study of KPI-121 Effect on Intra- or Subretinal Fluid Due to Retinal Vein Occlusion/Diabetic Macular Edema (NA)

Primary sources

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