Azura Ophthalmics to Present New Data on AZR-MD-001 in Meibomian Gland Dysfunction at ASCRS and ARVO

Azura Ophthalmics 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). Data will be featured at the upcoming Annual Meetings for the Association for Research in Vision and Ophthalmology (ARVO) April 23-27 in New Orleans, and the American Society of Cataract and Refractive Surgery (ASCRS) May 5-8 in San Diego.

“At Azura, we are addressing MGD in a completely new way and our mission is to bring relief to the countless patients who are burdened by it and associated ocular surface conditions,” Marc Gleeson, Chief Executive Officer of Azura, said in a company news release. “AZR-MD-001 is the first investigational medicine to achieve a positive sign and symptom outcome for Meibomian Gland Dysfunction. We are excited to present our data across multiple presentations at these prestigious conferences and we expect to advance AZR-MD-001 into a pivotal phase 3 trial this year.”

Details for the poster presentations are as follows:

ARVO sessions:

Title: B0313: Nonclinical assessment of repeated dosing of AZR-MD-001 to the lower eyelid (Selenium Sulphide, SeS2, sterile ophthalmic ointment): A novel therapy being developed for meibomian gland dysfunction
Session Date & Time: April 23, 8:00-9:45 a.m. CT
Presenter: Limor Miara, Azura Ophthalmics
Location: Exhibit Hall

Title: B0328: AZR-MD-001 efficacy in improving tear film stability and its impact on associated symptoms of meibomian gland dysfunction in a Phase 2 trial
Session Date & Time: April 26, 10:30 a.m.-12:15 p.m. CT
Presenter: Fiona Stapleton, University of South Wales Medicine & Health
Location: Exhibit Hall

Title: B0026: AZR-MD-001 efficacy in resolving the signs and associated symptoms of meibomian gland dysfunction (MGD) in a Phase 2 trial: responder status analysis
Session Date & Time April 27, 10:30 a.m.-12:15 p.m. CT
Presenter: Lisa M. Nijm, M.D., J.D., Warrenville EyeCare & Lasik, University of Illinois Eye & Ear Infirmary
Location: Exhibit Hall

Title: B0072: AZR-MD-001 restores gland function and improves signs and ocular symptoms of Meibomian Gland Dysfunction (MGD)
Session Date & Time: April 27, 10:30 a.m.-12:15 p.m. CT
Presenter: Preeya K. Gupta, M.D., Triangle Eye Consultants, Tulane University
Location: Exhibit Hall

ASCRS sessions:

Title: AZR-MD-001 Efficacy in Resolving the Signs and Associated Symptoms of Meibomian Gland Dysfunction (MGD): Phase 2 Trial Responder Status
Session Date & Time: May 7, 10:05-10:10 a.m. PT
Presenter: Lisa M. Nijm, M.D., J.D., Jennifer P Craig, O.D., Ph.D.
Location: SDCC – Upper Level, Room 4

Title: AZR-MD-001 Efficacy in Restoring Gland Function and Improving Signs and Ocular Symptoms of Meibomian Gland Dysfunction (MGD): A Phase 2 Trial
Session Date & Time: May 7, 10:55-11:00 a.m. PT
Presenter: Preeya K. Gupta, M.D.
Location: SDCC – Upper Level, Room 4

About AZR-MD-001

Azura’s lead clinical-stage drug candidate, AZR-MD-001, harnesses the power of selenium sulfide (SeS2) in an easy-to-use ophthalmic ointment preparation applied directly to the meibomian glands in the lower eyelid. AZR-MD-001 is thought to have a multi-modal mechanism of action that treats the pathophysiology of Meibomian Gland Dysfunction along with the resulting ocular surface symptoms. It breaks down the bonds between abnormal keratin proteins to soften the blockage, slows down the production of keratin to prevent future blockages and increases the quality and quantity of meibum produced by the meibomian glands.

AZR-MD-001 is currently being studied to evaluate the safety, efficacy, and tolerability of the study drug in patients with MGD. Azura expects to initiate a second pivotal multi-center clinical trial of AZR-MD-001 0.5% in 2023.