Drugs / KIO-201
KIO-201
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT05436288 | Jul → Dec 2022 | corneal disorder | Kiora Pharmaceuticals, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2023-04-26 | Kiora Pharmaceuticals, Inc. | Results Kiora Pharmaceuticals' KIO-201 Heals Wounds in Phase 2 Trial of Patients with Persistent Corneal Epithelial Defects kiorapharma.com ↗
Outcomes from the trial demonstrated the following: 5 of 8 patients (62.5%) achieved the primary endpoint of healing over the 4-week period. |
| 2019-06-03 | Kiora Pharmaceuticals, Inc. | Regulatory EyeGate Receives Approval from FDA to Initiate PRK Pivotal Study kiorapharma.com ↗
EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG) ("EyeGate" or "the Company") announced today it has received approval from the U.S. Food and Drug Administration ("FDA") to initiate its photorefractive keratectomy ("PRK") pivotal study. |
| 2019-05-02 | Kiora Pharmaceuticals, Inc. | Regulatory EyeGate Files IDE with FDA for PRK Pivotal Study kiorapharma.com ↗
EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG) (''EyeGate'' or ''the Company'') announced today it has successfully submitted the Investigational Device Exemption (''IDE'') to the U.S. Food and Drug Administration (''FDA") regarding its photorefractive keratectomy (''PRK'') pivotal study. |
| 2018-11-13 | Kiora Pharmaceuticals, Inc. | Results EyeGate Pharma Announces Positive Results in Punctate Epitheliopathy Study kiorapharma.com ↗
EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG) today announced top-line data from its study evaluating the potential of EyeGate’s Ocular Bandage Gel (OBG) to help clinicians better manage patients with punctate epitheliopathies (PE) due to pathologies such as dry eye. |
| 2018-06-22 | Kiora Pharmaceuticals, Inc. | Regulatory EyeGate Addresses Final FDA Action Item with Submission of IDE Amendment for Ocular Bandage Gel kiorapharma.com ↗
EyeGate’s product is a cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S) platform being developed for the acceleration of re-epithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy (PRK). |
| 2018-05-30 | Kiora Pharmaceuticals, Inc. | Regulatory EyeGate Files Supplement to Investigational Device Exemption to Commence Study in Punctate Epitheliopathy using the EyeGate Ocular Bandage Gel kiorapharma.com ↗
EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), a clinical-stage, specialty pharmaceutical company with two proprietary platform technologies for treating diseases and disorders of the eye, today announced the filing of an Investigational Device Exemption (IDE) supplement for Punctate Epitheliopathy (PE), using the Company’s Ocular Bandage Gel (OBG) product. |
| 2018-05-22 | Kiora Pharmaceuticals, Inc. | Regulatory EyeGate Addresses Majority of FDA’s Action Items with Submission of Investigational Device Exemption Amendment for Ocular Bandage Gel kiorapharma.com ↗ |
| 2018-03-08 | Kiora Pharmaceuticals, Inc. | Regulatory EyeGate Pharma Submits Investigational Device Exemption Amendment for Second Pilot Study of Ocular Bandage Gel kiorapharma.com ↗ |
| 2017-05-04 | Kiora Pharmaceuticals, Inc. | Regulatory EyeGate Submits Investigational Device Exemption (IDE) Filing for Second Pilot Study of Ocular Bandage Gel kiorapharma.com ↗
The IDE submission is subject to review by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA), and must be approved prior to initiating this study. |
| 2017-01-30 | Kiora Pharmaceuticals, Inc. | Results EyeGate Pharma Announces Positive Top-line Data from First-in-Human Pilot Trial of Ocular Bandage Gel in Corneal Epithelial Defects kiorapharma.com ↗
EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), a specialty pharmaceutical company that focuses on developing and commercializing products for treating diseases and disorders of the eye, today announced topline results from the first-in-human pilot trial of its EyeGate Ocular Bandage Gel (“EyeGate OBG”) for the acceleration of re-epithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy (“PRK”). |
All press releases naming this drug 15 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | KIO-201 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05436288 ↗ |
| Known as | CMHA-S | “KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S), up to 6 times a day for 4 weeks.” NCT05436288 ↗ |
| Known as | Crosslinked Thiolated Carboxymethyl Hyaluronic Acid | “KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S), up to 6 times a day for 4 weeks.” NCT05436288 ↗ |
| Modality | Other / unclassified | “KIO-201 is a stand-alone drug therapy” NCT05436288 ↗ |
| Route | Topical | “topical KIO-201” NCT05436288 ↗ |