Azura’s Phase IIb for Meibomian Gland Dysfunction Trial Hits Co-Primary Endpoints

November 17, 2022

Meibomian Gland Dysfunction, or MGD, is a disease of the eyes that is caused by abnormal keratin production that causes blocked glands. This affects the amount and quality of meibum secretions in the upper and lower eyelids, causing inflammation of the surface of the eye, dry eye, pain, irritation and vision problems.

Tel Aviv, Israel and Melbourne, Australia-based Azura Ophthalmics announced positive three- months efficacy and safety data from a Phase IIb trial of AZR-MD-001 0.5% in MGD. The study hit the co-primary endpoints, improvements in Meibomian Glands Yielding Liquid Secretion (MGYLS, or the number of open glands), and Ocular Surface Disease Index (OSDI, or improved symptoms).

It also hit other clinically meaningful endpoints, such as improvements in meibum quality, improvements in tear stability, and improvements across multiple patient-reported outcome measures (SPEED and average VAS).

The drug is an ointment applied directly to the meibomian glands in the lower eyelid. The company says that the drug, which “harnesses the power of selenium sulfide” (their words), dissolves the bonds between abnormal keratin proteins, resulting in a softening of the blockage and slower keratin production.

“At Azura, we are taking a completely new approach to treating MGD which is the root cause of many downstream ocular surface conditions,” noted Marc Gleason, Azura’s CEO.

Gleeson went on to say, “These data clearly demonstrate consistency in efficacy across multiple sign and symptom endpoints. With as little as four applications of AZR-MD-001, improvement in glandular function was observed and continued to improve over three months. We are thrilled to build upon these positive results by advancing AZR-MD-001 to a pivotal Phase III clinical trial for MGD in 2023.”

According to a Coherent Market Insights report issued in 2021, the U.S. market alone was $1.976 billion in 2020 and expected to increase by a CAGR of 15.4% from 2020-2030. Other treatments on the market include TearScience’s LipiFlow and LipiScan. TearScience is a subsidiary of Johnson and Johnson Vision Care. Allergen, now AbbVie, has the Refresh Repair Lubricant Eye Drops. And OASIS Medical has Oasis Tears Omega 3 and Oasis Tears Vision.

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markdrewterry

A freelance writer and editor, Mark Terry writes extensively about the biopharma industry. His work includes news articles, white papers, webinar scripts, sponsored articles, survey reports, book-length market research reports and books.

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