Doctors may prescribe steroids or eye drops for patients with dry eye. But Azura Ophthalmics wants to do one better with a drug that tackles the root cause of the disease. To that end, it’s raised $20 million, which will bankroll a pivotal trial in the first quarter of 2021.
Unlike Allergan’s Restasis, an immunosuppressant, and Novartis’ Xiidra, an anti-inflammatory drug, Azura’s lead program, AZR-MD-001, is designed to address the abnormal buildup of proteins in the eyelids’ meibomian glands.
“There are about 20 glands in the lower lid and about 40 in the upper lid. They produce an oil every time you blink,” Azura CEO Marc Gleeson said. This oil, called meibum, coats the surface of the eye and stops the water in tears from evaporating. Over time, some people’s glands can become blocked with excess keratin proteins.
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“This can occur at the opening of the gland, or in the gland itself, and it changes both the ability of the meibum to come out of the gland and the consistency of the oil. That’s the fundamental problem,” Gleeson said.
“What most other therapies are targeting is the impact of meibomian gland dysfunction—symptoms like inflammation, itchiness and scratchiness that patients describe,” he added.
Both Restasis and Xiidra are eye drops, which tackle symptoms on the eye’s surface, but AZR-MD-001 is an ointment that goes on the eyelids. It is a reformulation of selenium disulfide—yes, the active ingredient in dandruff shampoo—that addresses meibomian gland dysfunction in three ways. It breaks the disulfide bonds that hold abnormal keratin aggregates together, slows down keratin production and boosts lipid production in the meibomian glands. It turns out an unwanted side effect in dandruff shampoo—an oily scalp—is a plus in treating dry eye.
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Beyond a pivotal trial in meibomian gland dysfunction, the new funding will support the development of AZR-MD-001 in other indications, including evaporative dry eye disease and contact lens intolerance. The company is also working on treatments for blepharitis, or inflammation of the eyelids, and aqueous deficient dry eye, in which patients don’t produce enough tears.
The funding comes from OrbiMed, TPG Biotech, Ganot Capital and Brandon Capital’s Medical Research Commercialisation Fund, and it follows a $16 million series B round in October 2017.