Azura Ophthalmics to Present New Data Supporting the Potential of AZR-MD-001 to be the First Ophthalmic Keratolytic for Ocular Surface Diseases
Azura Ophthalmics announced multiple presentations highlighting positive efficacy and safety data from phase 2 studies of the company’s lead drug candidate, AZR-MD-001, in meibomian gland dysfunction (MGD). This includes new, long-term data at ASCRS of the company’s lead drug candidate, AZR-MD-001, showing improvement in both signs and symptoms in MGD and contact lens discomfort (CLD). Data from 10 abstracts will be featured at the upcoming annual meetings for the American Society of Cataract and Refractive Surgery (ASCRS), April 5-8 in Boston, and the Association for Research in Vision and Ophthalmology (ARVO), May 5-9 in Seattle.
“Together, the data set we are presenting at these prestigious conferences show multiple potential patient benefits and mild, transient side effects in a topical medicine, supporting the potential of AZR-MD-001 as an entirely new approach targeting the underlying cause of many ocular surface diseases,” Marc Gleeson, Chief Executive Officer of Azura, said in a company news release. “We look forward to initiating our phase 3 trial in Q2 2024 and working with investigators and patients to advance our goal of bringing symptom relief to people burdened by MGD and associated ocular surface conditions.”
Details for the poster presentations are as follows:
ASCRS sessions:
Abstract title | Abstract presentation details |
Correlation of Patient Outcomes with Indicators of Meibomian Gland Dysfunction Following Treatment with AZR-MD-001 | Session Date & Time: April 6 1:30-1:35 p.m. EDT |
Improvement in Ocular Signs and Symptoms of Meibomian Gland Dysfunction (MGD) after 6 Months of AZR-MD-001 Treatment | Session Date & Time: April 8, 9:10-9:15 a.m. EDT |
ARVO sessions:
Abstract title | Abstract presentation details |
AZR-MD-001 Improved Corneal and Conjunctival Damage in Patients with CLD and MGD | Posterboard number: B0505 |
AZR-MD-001 Opens Meibomian Glands, Improves Meibum and Tear Quality Resulting in Increased Wear Time and Desired Lens Use in Patients With CLD | Posterboard number: B0513 |
AZR-MD-001 Efficacy in Resolving the Signs and Associated Symptoms of Contact Lens Discomfort in a Phase 2 Trial | Posterboard number: A0130 |
Validity of the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and its comprehensiveness in assessing disease impact after the widespread adoption of digital media in patients with Contact Lens Discomfort (CLD) and concomitant Meibomian Gland Dysfunction (MGD) | Posterboard number: B0315 |
Safety and Efficacy of Topical AZR-MD-001 for the Treatment of Meibomian Gland Dysfunction in a 6-Month Study | Posterboard number: B0265 |
Sign and Symptom Improvement Rates Among MGD Patients Following Treatment With AZR-MD-001 for 6 Months | Posterboard number: B0269 |
AZR-MD-001 Improved Tear Film Stability and Ocular Symptoms in Patients with Meibomian Gland Dysfunction: 6-Month Results | Posterboard number: B0270 |
AZR-MD-001 Ophthalmic Ointment Opens Meibomian Glands, Improves Meibum Quality, and Tear Film Stability Over 3 Months of Dosing in Patients with Contact Lens Discomfort | Posterboard number: B0271 |
Azura’s lead clinical-stage, investigational drug candidate AZR-MD-001 harnesses the power of selenium sulfide (SeS2) in an ophthalmic ointment preparation applied directly to the meibomian glands in the lower eyelid. It is transferred to the meibomian glands in the upper eyelid when the patient blinks. AZR-MD-001 is thought to have a multi-modal mechanism of action that treats the pathophysiology of MGD 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 clinical signs of MGD. This product has not been approved by the FDA.