Leang Ronika S, Kloft Lisa J, Gray Brad, Gwon Arlene E, Huang Ling C
Biological Sciences, Johnson & Johnson Surgical Vision, Inc., Santa Ana, CA, USA.
Gavin Herbert Eye Institute, University of California, Irvine, CA, USA.
Ophthalmol Ther. 2019 Mar;8(1):101-114. doi: 10.1007/s40123-019-0167-9. Epub 2019 Feb 18.
To establish the preclinical safety and equivalency of ophthalmic viscosurgical devices (OVDs) comprised of bacterially sourced sodium hyaluronate (HA) to animal sourced HA using pyrogenicity and aqueous exchange models in rabbits and a novel mini-pig model to evaluate corneal endothelial cell protection in vivo.
HEALON OVD and HEALON5 OVD containing animal-derived HA and HEALON PRO OVD and HEALON5 PRO OVD containing bacterial-derived HA were used. Two rabbit aqueous exchange studies were conducted where aqueous humor was exchanged with OVDs in six animals each to observe potential ocular inflammation, intraocular pressure (IOP) response, corneal health and pachymetry until 7 days post procedure, as well as overall assessment of the OVDs. Endothelial cell protection was evaluated in a Yucatan mini-pig cataract surgery model where HEALON PRO and HEALON5 PRO OVDs were compared to HEALON and HEALON5 OVDs, respectively. Following cataract surgery with use of OVDs in six animals per study, animals were evaluated for ocular and general health, IOP, corneal thickness, ocular inflammation, and endothelial cell protection on days 1, 3, 7 and 14 post-surgery.
All rabbit studies demonstrated equivalence between bacterial-derived and animal-derived OVDs. Mild, post-surgical irritation, IOP increase, and corneal thickness measurements were not significantly different in HEALON PRO OVD and HEALON5 PRO OVD compared to HEALON and HEALON5 OVDs, respectively. The mini-pig model developed to investigate endothelial cell protection was successful in demonstrating equivalence between the OVDs studied. Changes in IOP mirrored actual surgical procedures, while corneal pachymetry and endothelial cell density remained constant for all OVDs used. Slit lamp observations showed expected inflammation following surgical procedures, likely due to challenges encountered during surgical procedures.
Rabbit pyrogenicity and aqueous exchanged paired with a novel simulated cataract surgery mini-pig model demonstrate equivalence of OVDs regardless of HA source. Albeit with challenges, the mini-pig model was shown to be a promising tool for endothelial cell evaluation during the development of new OVDs for ophthalmic use.
Johnson & Johnson Surgical Vision, Inc.
利用家兔的热原性和房水交换模型以及一种新型小型猪模型，在体内评估角膜内皮细胞保护作用，以确立由细菌来源的透明质酸钠（HA）组成的眼科粘弹剂（OVD）与动物来源的HA的临床前安全性和等效性。
使用含动物源性HA的HEALON OVD和HEALON5 OVD，以及含细菌源性HA的HEALON PRO OVD和HEALON5 PRO OVD。进行了两项家兔房水交换研究，每组六只动物，将房水与OVD进行交换，观察术后7天内潜在的眼部炎症、眼压（IOP）反应、角膜健康状况和角膜厚度，以及对OVD的总体评估。在尤卡坦小型猪白内障手术模型中评估内皮细胞保护作用，将HEALON PRO和HEALON5 PRO OVD分别与HEALON和HEALON5 OVD进行比较。每项研究中，每组六只动物在白内障手术中使用OVD后，在术后第1、3、7和14天对动物的眼部和全身健康状况、眼压、角膜厚度、眼部炎症和内皮细胞保护作用进行评估。
所有家兔研究均表明细菌来源的OVD与动物来源的OVD等效。与HEALON和HEALON5 OVD相比，HEALON PRO OVD和HEALON5 PRO OVD术后的轻度刺激、眼压升高和角膜厚度测量结果无显著差异。为研究内皮细胞保护作用而建立的小型猪模型成功地证明了所研究的OVD之间的等效性。眼压变化反映了实际手术过程，而所有使用的OVD的角膜厚度和内皮细胞密度保持不变。裂隙灯观察显示手术后出现预期的炎症，可能是由于手术过程中遇到的挑战。
家兔热原性和房水交换与新型模拟白内障手术小型猪模型相结合，证明了无论HA来源如何，OVD均具有等效性。尽管存在挑战，但小型猪模型被证明是开发新型眼科用OVD过程中评估内皮细胞的一种有前景的工具。
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