A novel topical high-concentrated, crosslinked hyaluronic acid eye drop could expand the options that surgeons have available for improving wound care, healing, and regenerative medicine for a variety of corneal injuries.
SAFETY AND EFFICACY
The objective of the study was to assess the safety and efficacy of this high-concentration, crosslinked HA eyedrop (referred to as the "Ocular Bandage Gel" [OBG] in the trial) in humans with large corneal epithelial defects that were created during refractive surgery.7 OBG was applied topically in accelerating re-epithelialization of 9-mm corneal defects.
The subjects provide a homogenous patient population with a consistent and uniform defect size for comparison between treatment options.
In the randomized, open-label, prospective study, 39 subjects receiving bilateral PRK had both eyes treated immediately after surgery with either the OBG alone administered QID, OBG (QID) and a bandage contact lens (BCL), or a BCL with artificial tears (AT).
Subjects receiving a 9-mm epithelial defect for PRK on day 0 were followed through day 28.
The primary performance endpoint was time to corneal re-epithelialization post-PRK as assessed at the slit lamp. Safety assessments included adverse events, vision, pain, slit lamp, intraocular pressure, and fundus exams.
BARBARA WIROSTKO, MD
E: [email protected]
Dr. Wirostko is chief medical officer for EyeGate Pharmaceuticals; co-founder of Jade Therapeutics; and adjunct professor of ophthalmology, Moran Eye Center, University of Utah, Salt Lake City. She is also a stockholder in EyeGate.
1. Wirostko B, Mann BK, Williams DL, Prestwich GD. Ophthalmic uses of a thiol-modified hyaluronan-based hydrogel. Adv Wound Care (New Rochelle) 2014; 3:708-716.
2. Yang G, Prestwich GD, Mann BK. Thiolated carboxymethyl-hyaluronic-Acid-based biomaterials enhance wound healing in rats, dogs, and horses. ISRN Vet Sci 2011; Article ID 851593. doi: 10.5402/2011/851593. Accessed July 7, 2017 at http://dx.doi.org/10.5402/2011/851593
3. Williams DL, Mann BK. A crosslinked HA-based hydrogel ameliorates dry eye symptoms in dogs. Int J Biomater 2013, Article ID 460437. Accessed July 7, 2017 at http://dx.doi.org/10.1155/2013/460437
4. Yang G, Espandar L, Mamalis N, Prestwich GD. A crosslinked hyaluronan gel accelerates healing of corneal epithelial abrasion and alkali burn injuries in rabbits. Vet Ophthalmol 2010; 13:144-150.
5. Williams DL, Wirostko BM, Gum G, Mann B. Topical crosslinked HA-based hydrogel accelerates closure of corneal epithelial defects and repair of stromal ulceration in companion animals. Invest Ophthalmol Vis Sci. 2017;58:4616-4622. doi: 10.1167/iovs.16-20848.
6. Williams DL, Mann BK. Efficacy of a crosslinked hyaluronic acid-based hydrogel as a tear film supplement: a masked controlled study. PLoS ONE 2014; 9: e99766. doi:10.1371/journal.pone.0099766. Accessed July 7, 2017 at http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0099766
7. Daniel S. Durrie MD, Darcy Wolsey, MD, MPH, Vance Thompson, MD, Carol Assang, Brenda Mann, PhD, Barbara Wirostko, MD. Accelerating re-epithelialization after photorefractive keratectomy with an ocular bandage gel. Journal of Cataract and Refractive Surgery. Accepted and in press Nov 2017.