A recombinant human hyaluronidase sustained release gel for the treatment of post-surgical edema

Int J Dermatol. 2014 Jun;53(6):777-85. doi: 10.1111/ijd.12304. Epub 2013 Oct 29.

Abstract

Background: Edema commonly accompanies surgical procedures and when excessive, can adversely affect surgical outcomes. The skin extracellular matrix, including one of its primary components, hyaluronan (HA), is a significant barrier to effective drainage of accumulated edematous fluid. Recombinant human hyaluronidase (rHuPH20) is a human hyaluronidase that acts transiently and locally to depolymerize HA. A non-liposomal gel formulation that provides a sustained release of rHuPH20 was tested in vivo in a preclinical murine model of acquired lymphedema.

Methods: Lymphedemic mice were injected 24 hours before surgery, and at 2 and 12 days following surgery with rHuPH20 sustained release gel (PH20 SR gel). Quantitative assessment of treatment response indicated that a single dose of PH20 SR gel resulted in accelerated resolution and reduced severity of post-surgical edema as compared to the gel vehicle (control).

Results: Statistically significant enzymatic degradation of HA was demonstrated up to 5 mm from the injection site, and histological analysis confirmed removal of HA up to 72 hours following PH20 SR gel administration.

Conclusions: These results demonstrate sustained hyaluronidase enzymatic activity that promotes diffusion of accumulated post-surgical edematous fluid, suggesting that PH20 SR gel may be a useful adjuvant in promoting postoperative edema resolution.

MeSH terms

  • Analysis of Variance
  • Animals
  • Delayed-Action Preparations / therapeutic use*
  • Disease Models, Animal
  • Hyaluronoglucosaminidase / therapeutic use*
  • Injections, Intralesional
  • Lymphedema / drug therapy*
  • Lymphedema / etiology
  • Mice
  • Postoperative Care
  • Postoperative Complications / diagnosis
  • Postoperative Complications / drug therapy*
  • Preoperative Care
  • Random Allocation
  • Recombination, Genetic
  • Reference Values
  • Time Factors
  • Treatment Outcome
  • Wound Healing / drug effects
  • Wound Healing / physiology

Substances

  • Delayed-Action Preparations
  • Hyaluronoglucosaminidase