1 Effectiveness of Hyaluronidase as an adjuvant in vitrectomy Supported by Riemser Arzneimittel AG, Greifswald-Insel Riems, Germany  Schönfeld et al., COPHy, Prague, 2010 Carl-Ludwig Schönfeld 1, Florian Pinter 2, Matthias Remy 2, Anselm Kampik 2 1 Eye Hospital Herzog Carl Theodor, Munich, Germany. 2 Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany. Prague 4-7 March, 2010

2 INTRODUCTION Hyaluronidase added to regional anesthetics has a depolymerizing effect on hyaluronic acid, but without tangible results except in ocular surgery (Kallio et al. 2000). Hyaluronidase has particular advantages in peribulbar anesthesia where it accelerates the absorption of bupivacaine (Nathan et al. 1996). Majority of clinical studies state significant beneficial effects of Hyaluronidase including: - earlier onset and more complete anesthesia and akinesia - less requirement for re-injections - better surgical conditions To evaluate the benefits and safety of a Hylase ® “Dessau”, in patients undergoing combined cataract extraction + pars plana vitrectomy (PPV) or only PPV.  Schönfeld et al., COPHy, Prague, 2010

3 MATERIALS & METHODS In a 2-year, prospective, randomized, double-blind, placebo-controlled Phase III clinical study 82 patients were recruited. The study was conducted as per good clinical practice (GCP) guidelines. The study medication was labelled - German Federal Drug Law (§10 Arzneimittelgesetz, AMG). The verum group received a retrobulbar injection of 75 I.E Hyaluronidase in combination with the local anesthetic (bupivacaine 0.75 % 5 ml + mepivacaine 1% 2 ml), placebo group received anaesthetic only. The analgesic action was recorded using a visual analogue scale (VAS).  Schönfeld et al., COPHy, Prague, 2010

4 MATERIALS & METHODS Inclusion criteria: - male and female >18 years - elective cataract and vitrectomy surgery - inadequately controlled ocular disease - no current or previous participation in another clinical trial (last 4 weeks). Exclusion criteria: - intolerance to Hyaluronidase - bovine protein or gelatine preparations - pregnancy or lactation in female volunteers - history of local anesthetic complications - muscular or peripheral nerve diseases.  Schönfeld et al., COPHy, Prague, 2010

5 DISCUSSION Fig. 1 shows that complete anesthesia was achieved within minutes after application in 41 patients in the Hylase ® “Dessau” and 34 patients (82.9 %) in the placebo group, respectively (p<0.05). Tolerability was excellent with no side effects in either groups. Explorative data evaluation yielded a superior effect of Hylase in terms of ptosis (10 min) after local anaesthetics. Due to incomplete akinesia and pain, Hylase group (7 patients) and placebo group (15 patients) needed an additional anesthetic treatment. Figure 1: Percentage of patients with complete anesthesia after minutes.  Schönfeld et al., COPHy, Prague, 2010

6 DISCUSSION Hylase Group Placebo Group Incomplete Akinesia Pain and incomplete Akinesia Pain Figure 2: Additional supplemental injections of local anesthesia. Figure 2 shows that with regard to secondary outcome parameters, 9 patients (22%) of the Hylase group and 15 patients (34 %) of the placebo group required additional supplemental injections after minutes because of incomplete anesthesia and / or akinesia. No significant statistical difference was observed with respect to akinesia in any group. 9 (22 %) 15 (34 %) Number of patients  Schönfeld et al., COPHy, Prague, 2010

7 CONCLUSION For ophthalmosurgery, it is crucial to achieve optimal conditions. This holds particularly true for vitreoretinal surgery with its delicate procedures. Tolerability was very good in both groups, and there were no side effects in either group noticed. Hylase ® provided a higher level of patient comfort, without apparent risks. Compared to placebo, Hylase ® substantially enhanced the safety of the operation procedure due to a quicker onset of complete anesthesia and more complete ptosis. Therefore, its addition to the anesthetic regimen in combined cataract and ppV surgery is recommended to provide the best perioperative conditions possible for patient and surgeon. ACKNOWLEDGEMENTS Authors thank Dr. Amit Gulati (Department of Research & Development, Eye Hospital Bellevue, Kiel, Germany) for his contributions in this poster.  Schönfeld et al., COPHy, Prague, 2010