Cutaneous and ocular toxicology · 2026
Safety and tolerability evaluation of a novel ophthalmic viscosurgical device containing bacterial-derived hyaluronic acid.
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Moreno Isabel Y, Kloft Lisa J, Gwon Arlene E, Ling C Huang
Аннотация
PURPOSE: The purpose of this study is to evaluate the pre-clinical safety and tolerability of a new ophthalmic viscoelastic device (OVD) containing bacterial-derived hyaluronic acid (HA) using an aqueous exchange model in rabbits.
METHODS: Intraocular pressure (IOP) and central corneal thickness (CCT) were measured to assess the ocular response of OVD use during cataract surgery. OVDs containing bacterial-sourced sodium hyaluronate (HA) (Healon EndoCoat brand) were used to exchange approximately 100 µL of the aqueous humor in 6 NZW rabbit eyes in vivo. IOP, central corneal thickness (CCT) and clinical ophthalmic examinations were measured in both eyes at post-operative 12 and 24 hours and days 3, 4, 8, 28 and 90.
RESULTS: There were no significant differences in the IOP and CCT measurements after aqueous exchange between HEALON EndoCoat and HEALON EndoCoat PRO OVDs. IOP returned to baseline values in both the test and control eyes by 24 hrs. CCT showed no difference between test and control eyes after day 8 and remained the same through days 28 and 90. Early postoperative results showed expected corneal haze, conjunctival congestion and swelling, and inflammatory cells in the anterior chamber of both eyes after aqueous exchange. By day 8, the ocular findings were similar between the two study eyes and within the normal range typically reported.
DISCUSSION: The results of this pre-clinical investigation support the safety and tolerability of the new bacterial-derived OVD in rabbits. There were no statistical differences in IOP and CCT measurements between the two OVDs whether the study endpoints occurred at 7 days or 3 months. Although the study was carried out for 90 days, no statistical differences in clinical performance were observed between OVDs after 7 days, indicating that a testing period that extends out to 90 days may not be medically necessary for pre-clinical studies.
METHODS: Intraocular pressure (IOP) and central corneal thickness (CCT) were measured to assess the ocular response of OVD use during cataract surgery. OVDs containing bacterial-sourced sodium hyaluronate (HA) (Healon EndoCoat brand) were used to exchange approximately 100 µL of the aqueous humor in 6 NZW rabbit eyes in vivo. IOP, central corneal thickness (CCT) and clinical ophthalmic examinations were measured in both eyes at post-operative 12 and 24 hours and days 3, 4, 8, 28 and 90.
RESULTS: There were no significant differences in the IOP and CCT measurements after aqueous exchange between HEALON EndoCoat and HEALON EndoCoat PRO OVDs. IOP returned to baseline values in both the test and control eyes by 24 hrs. CCT showed no difference between test and control eyes after day 8 and remained the same through days 28 and 90. Early postoperative results showed expected corneal haze, conjunctival congestion and swelling, and inflammatory cells in the anterior chamber of both eyes after aqueous exchange. By day 8, the ocular findings were similar between the two study eyes and within the normal range typically reported.
DISCUSSION: The results of this pre-clinical investigation support the safety and tolerability of the new bacterial-derived OVD in rabbits. There were no statistical differences in IOP and CCT measurements between the two OVDs whether the study endpoints occurred at 7 days or 3 months. Although the study was carried out for 90 days, no statistical differences in clinical performance were observed between OVDs after 7 days, indicating that a testing period that extends out to 90 days may not be medically necessary for pre-clinical studies.