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KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75%

Phase 2

Persistent Corneal Epithelial Defect | Small molecule | Ophthalmology |Kiora Pharmaceuticals, Inc.|Last Updated: Apr 3, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% · 1 trial · 1 indication

Phase 2 1
NCT05436288A Study of the KIO-201 (Ocular Bandage Gel) for Improving Persistent Corneal Epithelial DefectsPersistent Corneal Epithelial Defect
COMPLETED10 Analytics
PHASE2COMPLETED
A Study of the KIO-201 (Ocular Bandage Gel) for Improving Persistent Corneal Epithelial Defects
Persistent Corneal Epithelial DefectUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Patients Achieving Corneal Healing (<0.5 mm2 Lesion Size) of the Persistent Corneal Epithelial Defect at 4 Weeks
4 weeks

Determined by corneal fluorescein staining and the effectiveness endpoint will also be evaluated by a reader using digital photography of fluorescein stained slit lamp photos and image analysis.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single arm activeEXPERIMENTALKIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S), up to 6 times a day for 4 weeks.

Interventions

NameTypeDescription
KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S)DRUGKIO-201 is a stand-alone drug therapy that acts as a barrier that minimizes mechanical lid friction and mechanically protects the ocular surface thereby reducing repeat injury and providing an environment that enables the body to repair the ocular surface whether the corneal epithelial defects are large or small.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients 18 years of age or older. * Patients with persistent corneal epithelial defects (PED) (Stage 1 and Stage 2 PED). * Patients with PED in one or both eyes, at least one eye meeting all study criteria. * Have PED of at least 2 weeks' duration refractory to one or more co...

Countries:Mexico
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Frequently asked questions about KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75%

What is KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% used for?

KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% is being developed for persistent corneal epithelial defect, an eye condition in which the cornea does not heal. It is an investigational ophthalmology product and is not approved for commercial use. Kiora Pharmaceuticals is studying it as an ocular bandage gel.

Who makes KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75%?

KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% is developed by Kiora Pharmaceuticals, Inc., which trades under the ticker KPRX. The company is the sponsor of the clinical program for this ocular bandage gel candidate.

What phase is KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% in?

KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% is in Phase 2 development. It is an investigational product and has not been approved by the FDA. The Phase 2 study has been completed, and no trials are currently active.

What clinical trials is KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% in?

KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% has been studied in one completed Phase 2 trial, NCT05436288, titled A Study of the KIO-201 (Ocular Bandage Gel) for Improving Persistent Corneal Epithelial Defects. The trial enrolled 10 participants in Mexico and was uncontrolled, with no randomization or blinding.

Is KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% the same as CMHA-S?

Yes. KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% is also known as CMHA-S, which stands for crosslinked thiolated carboxymethyl hyaluronic acid. Both names refer to the same investigational ocular bandage gel being developed by Kiora Pharmaceuticals for persistent corneal epithelial defect.