Development and pharmacodynamic evaluation of recombinant human lysozyme eye drops

Dry eye disease (DED) is a multifactorial ocular surface disease. The commonest treatment is artificial tears. A novel artificial tears is urgently required to treat DED pathophysiologically, more than symptoms relief. In this study, a novel artificial tears with highly purified recombinant human lysozyme (rhLYZ), high homologous with natural tear, was obtained for DED treatment on a established rabbit DED model. 36 models were divided into 6 groups (n = 6), and treated with different concentration of novel artificial tears 180µl of drops daily, continuously for 4 weeks. To evaluate pathophysiologic therapeutic effect of the novel artificial tears, rabbit eyes were performed to the schirmer I test, tear ferning test, and corneal fluorescein staining test in 0, 1, 2, 3 and 4 weeks post-administration, respectively. The sacrificed models' corneas in 4 weeks were performed by pathological section staining. In the project, the quality of the artificial tears including rhLYZ was up to the quality standards of pharmacopoeia. RhLYZ eye drops, especially in the medium (0.15% of rhLYZ) and the high(0.30% of rhLYZ) concentration, enable to improve dry eye symptoms effectively, benefit to anti-inflammatory function and promote corneal repair. The novel artificial tears is a promising pathophysiological therapeutic agent in DED treatment.