Subconjunctival sirolimus-loaded liposomes may be effective in dry eye disease
A novel sirolimus liposomal formulation was beneficial for the treatment of signs and symptoms of moderate to severe dry eye disease, according to a study.
In his presentation at the virtual Association for Research in Vision and Ophthalmology meeting, Alejandro Navas, MD, PhD, said that current treatment options for severe cases of dry eye disease are limited.
“Owing to its powerful immunosuppressive effects, local application of sirolimus could potentially play a significant role in the treatment of immune-mediated ocular surface diseases,” he said.
Researchers conducted a randomized, triple-masked phase 2 clinical trial comprising 38 eyes of 19 patients. They assigned 10 patients to receive three doses of subconjunctival liposome-encapsulated sirolimus and nine to receive three doses of liposomal suspension without sirolimus (sham).
They measured Ocular Surface Disease Index, as well as corrected distance visual acuity, conjunctival hyperemia, tear osmolarity, Schirmer’s test, corneal/conjunctival staining and matrix metalloproteinase-9 before and after treatment.
In the treatment group, OSDI scores improved from 62.19 to 37.8 (P = .0024), and in the sham group, they changed from 60.02 to 36.02 (P = .01). In the treatment group, conjunctival hyperemia changed from 2 to 0.83 (P < .0001), and in the sham group, it changed from 1.33 to 0.94 (P = .048).
Patients in the treatment group also experienced improvements in corneal/conjunctival staining score (P = .0015), lipid layer interferometry (P = .006) and inferior meibomian gland dropout (P = .038).
“Moderate and severe dry eye is challenging, and new effective therapies and treatment modalities are still needed,” Navas said. “Novel sirolimus liposomal formulation could be used in ocular surface diseases.”
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Navas A, et al. Subconjunctival sirolimus-loaded liposomes for the treatment of moderate to severe dry eye disease. Presented at: Association for Research in Vision and Ophthalmology annual meeting; May 1-7, 2021 (virtual meeting).
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