Meibomian Gland Treatment

Study finds ointment improves both signs and symptoms of MGD. Howard Larkin reports from ASCRS 2021 in Las Vegas, USA

Aselenium sulphide ointment has the potential to be the first pharmacotherapy effective for treating the signs and symptoms of meibomian gland disease (MGD), announced Edward J Holland MD at the annual meeting.

In a phase 2 study, both a 0.5% and a 1.0% preparation of AZR-MD-001 (Azura) significantly improved the percentage of patients with normal open meibomian glands compared with placebo after three months of treatment, Dr Holland said. Both doses significantly improved ocular symptoms as measured by the total ocular surface disease index (OSDI) as well.

The higher dose also significantly improved the percentage of patients with normal meibum. Having met FDA requirements for showing both sign and symptom improvements, the compound is advancing to phase 3 development, he added.

DISSOLVING SULPHIDE BONDS MGD results from the formation of aberrant disulphide bonds in the meibum, which thickens and solidifies it through hyperkeratinisation. This leads to blockage and eventual atrophy of the meibomian glands, Dr Holland explained.

AZR-MD-001 addresses the disease in three ways: First, it slows both the rate of keratinocyte proliferation and keratin production. Second, it softens the keratin plug by breaking down disulphide bonds. Third, it stimulates lipogenesis to increase the number of lipids the meibomian glands produce.

In a study involving 95 patients testing 0.1%, 0.5%, and 1.0% doses with a vehicle control, the two higher doses improved the number of open meibomian glands significantly more than the vehicle and baseline, with 46% of patients on the highest dose achieving normal open glands compared with 8% on vehicle, Dr Holland reported. The 1.0% preparation also significantly improved the number of patients with liquid meibum compared with controls. Both were primary sign endpoints.

Both higher doses also significantly improved OSDI scores from baseline, with 58% of patients on 0.6% and 42% of patients on 1.0% symptom-free compared with 16% of controls. This reached the primary symptom endpoint.

No serious adverse events were observed during the study, Dr Holland said. Eye pain, irritation, and increased lacrimation were noted in the higher doses, though 96% of adverse events were mild to moderate. Dosing was twice weekly at bedtime.

In addition to meeting its primary endpoints, AZR-MD-001’s “safety and tolerability profile was certainly satisfactory,” Dr Holland concluded.

Edward Holland MD is the Director of Cornea Services at Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati, Ohio, USA. He is also a past president of ASCRS. edward.holland@uc.edu, eholland@holprovision.com

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