Preclinical Safety Evaluation of Ophthalmic Viscosurgical Devices in Rabbits and a Novel Mini-Pig Model
Abstract Introduction 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...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Adis, Springer Healthcare
2019-02-01
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| Series: | Ophthalmology and Therapy |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1007/s40123-019-0167-9 |
| _version_ | 1819289538594340864 |
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| author | Ronika S. Leang Lisa J. Kloft Brad Gray Arlene E. Gwon Ling C. Huang |
| author_facet | Ronika S. Leang Lisa J. Kloft Brad Gray Arlene E. Gwon Ling C. Huang |
| author_sort | Ronika S. Leang |
| collection | DOAJ |
| description | Abstract Introduction 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. Methods 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. Results 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. Conclusion 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. Funding Johnson & Johnson Surgical Vision, Inc. |
| first_indexed | 2024-12-24T03:08:27Z |
| format | Article |
| id | doaj.art-2b7ac06696e941dca90e0074def1bc74 |
| institution | Directory Open Access Journal |
| issn | 2193-8245 2193-6528 |
| language | English |
| last_indexed | 2024-12-24T03:08:27Z |
| publishDate | 2019-02-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Ophthalmology and Therapy |
| spelling | doaj.art-2b7ac06696e941dca90e0074def1bc742022-12-21T17:17:54ZengAdis, Springer HealthcareOphthalmology and Therapy2193-82452193-65282019-02-018110111410.1007/s40123-019-0167-9Preclinical Safety Evaluation of Ophthalmic Viscosurgical Devices in Rabbits and a Novel Mini-Pig ModelRonika S. Leang0Lisa J. Kloft1Brad Gray2Arlene E. Gwon3Ling C. Huang4Biological Sciences, Johnson & Johnson Surgical Vision, Inc.Biological Sciences, Johnson & Johnson Surgical Vision, Inc.Biological Sciences, Johnson & Johnson Surgical Vision, Inc.Gavin Herbert Eye Institute, University of CaliforniaBiological Sciences, Johnson & Johnson Surgical Vision, Inc.Abstract Introduction 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. Methods 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. Results 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. Conclusion 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. Funding Johnson & Johnson Surgical Vision, Inc.http://link.springer.com/article/10.1007/s40123-019-0167-9Cataract surgeryEndothelial cellHEALON OVDHEALON PRO OVDOphthalmic viscosurgical deviceSodium hyaluronate |
| spellingShingle | Ronika S. Leang Lisa J. Kloft Brad Gray Arlene E. Gwon Ling C. Huang Preclinical Safety Evaluation of Ophthalmic Viscosurgical Devices in Rabbits and a Novel Mini-Pig Model Ophthalmology and Therapy Cataract surgery Endothelial cell HEALON OVD HEALON PRO OVD Ophthalmic viscosurgical device Sodium hyaluronate |
| title | Preclinical Safety Evaluation of Ophthalmic Viscosurgical Devices in Rabbits and a Novel Mini-Pig Model |
| title_full | Preclinical Safety Evaluation of Ophthalmic Viscosurgical Devices in Rabbits and a Novel Mini-Pig Model |
| title_fullStr | Preclinical Safety Evaluation of Ophthalmic Viscosurgical Devices in Rabbits and a Novel Mini-Pig Model |
| title_full_unstemmed | Preclinical Safety Evaluation of Ophthalmic Viscosurgical Devices in Rabbits and a Novel Mini-Pig Model |
| title_short | Preclinical Safety Evaluation of Ophthalmic Viscosurgical Devices in Rabbits and a Novel Mini-Pig Model |
| title_sort | preclinical safety evaluation of ophthalmic viscosurgical devices in rabbits and a novel mini pig model |
| topic | Cataract surgery Endothelial cell HEALON OVD HEALON PRO OVD Ophthalmic viscosurgical device Sodium hyaluronate |
| url | http://link.springer.com/article/10.1007/s40123-019-0167-9 |
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