Drugs / AZR-MD-001
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT05548491 | Nov 2022 → Oct 2023 | contact lens corneal edema | Azura Ophthalmics | Completed | Met primary |
| Phase 2 | NCT04391959 | Jul 2020 → Jan 2021 | eye adnexa disorder | Azura Ophthalmics | Completed | No outcome recorded |
| Phase 2 | NCT03972501 | Oct 2019 → Dec 2020 | eye disorder | Azura Ophthalmics | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT04314362 | Jul 2020 → Jan 2021 | eye adnexa disorder | Azura Ophthalmics | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT06329791 | May → Dec 2024 | dry eye syndrome | Azura Ophthalmics | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2024-03-28 | Azura Ophthalmics | Results Azura Ophthalmics to Present New Data Supporting the Potential of AZR-MD-001 to be the First Ophthalmic Keratolytic for Ocular Surface Diseases azuraophthalmics.com ↗
New and updated data show investigational AZR-MD-001 demonstrates durability of response in improving ocular signs and symptoms of Meibomian Gland Dysfunction (MGD) after six months of treatment |
| 2023-12-18 | Azura Ophthalmics | Results Azura Ophthalmics Announces Positive Results from Phase 2 Clinical Trial of AZR-MD-001 in Patients with Contact Lens Discomfort azuraophthalmics.com ↗
The trial met its primary endpoint of showing a statistically significant improvement in Meibomian Glands Yielding Liquid Secretion (MGYLS; number of open glands). |
| 2023-04-20 | Azura Ophthalmics | Results Azura Ophthalmics to Present New Data on AZR-MD-001 in Meibomian Gland Dysfunction at American Society of Cataract and Refractive Surgery and Association for Research in Vision and Ophthalmology Annual Meetings azuraophthalmics.com ↗
Azura Ophthalmics Ltd., a clinical-stage biopharmaceutical company developing a new therapeutic class of Ophthalmic Keratolytics for ocular surface diseases, today announced multiple presentations featuring positive efficacy and safety data from a Phase 2b study of the company’s lead drug candidate, AZR-MD-001, in Meibomian Gland Dysfunction (MGD). |
| 2022-12-09 | Azura Ophthalmics | Results Azura Ophthalmics Presents Positive Results from Phase 2b Clinical Trial of AZR-MD-001 in Meibomian Gland Dysfunction at Ophthalmology Innovation Summit XII azuraophthalmics.com ↗
The results from Azura’s Phase 2b study of AZR-MD-001 0.5% in MGD were presented during the “Spotlight on Dry Eye” session at OIS XII. |
| 2022-11-17 | Azura Ophthalmics | Results Azura Ophthalmics Announces Positive Results from Phase 2b Clinical Trial of AZR-MD-001 in Meibomian Gland Dysfunction azuraophthalmics.com ↗ |
| 2022-09-28 | Azura Ophthalmics | Regulatory Azura Ophthalmics Provides Update on AZR-MD-001 Phase 2 Clinical Program Targeting Meibomian Gland Dysfunction azuraophthalmics.com ↗
Receives IND clearance for Phase 2b program in U.S. |
| 2021-03-03 | Azura Ophthalmics | Results Azura Ophthalmics Announces Positive Topline Results from Phase 2 Program of the Company’s Investigational Treatment for Meibomian Gland Dysfunction azuraophthalmics.com ↗
AZR-MD-001 met its primary endpoints showing improvements in signs and symptoms of MGD, reaching statistical significance compared to control. |
| 2020-12-21 | Azura Ophthalmics | Results Azura Ophthalmics Announces Primary Endpoints Met in Topline Results from Phase 2 Trial of the Company’s Investigational Treatment for Contact Lens Discomfort azuraophthalmics.com ↗
The ECLIPTIC study examining Azura’s lead asset, AZR-MD-001, met its primary endpoints by showing statistically significant improvements in multiple measures of Meibomian gland secretion and patients’ ability to wear contact lenses as desired. |
All press releases naming this drug 11 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AZR-MD-001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05548491 ↗ |
| Route | Topical | “AZR-MD-001 sterile ophthalmic ointment 0.5%” NCT06329791 ↗ |