Postoperative Ocular Inflammation: A Single Subconjunctival Injection of XG-102 Compared to Dexamethasone Drops in a Randomized Trial.
OBJECTIVE
To evaluate the efficacy and safety of XG-102 (brimapitide) compared to dexamethasone eye drops in the treatment of postoperative ocular inflammation.


METHODS
Multicenter, randomized, parallel group, double-masked, noninferiority clinical trial.


METHODS
Patients who underwent anterior and posterior segments combined surgery or glaucoma surgery or complex posterior segment surgery were eligible to participate. Patients were administered a single subconjunctival injection of 250 μL XG-102 90 μg (n = 47) or 900 μg (n = 48) or placebo (n = 50) at the end of ocular surgery. Subconjunctival injection for each group (XG-102 90 μg, XG-102 900 μg, or placebo) was followed by eye drops instilled 4 times per day for 21 days with placebo, placebo, or dexamethasone solution, respectively. The primary outcome measure was anterior chamber cell grades at day 28 comparing XG-102 900 μg with dexamethasone.


RESULTS
The anterior cell grades for both XG-102 groups were noninferior to dexamethasone (-0.054 anterior cell grade [95% confidence interval -0.350-0.242]; P < .001 for noninferiority) for XG-102 900 μg and -0.086 anterior cell grade (95% confidence interval -0.214-0.385; P = .003 for noninferiority) for XG-102 90 μg. Rescue medication was introduced for 10 (21%), 7 (15%), and 2 (4%) patients allocated to the XG-102 90 μg, XG-102 900 μg, and dexamethasone groups, respectively. The difference between XG-102 90 μg and dexamethasone was statistically significant (P = .013). The number of patients for whom adverse events were reported and the nature of the events reported was similar between the 3 treatment groups.


CONCLUSIONS
A single subconjunctival injection of XG-102 at the end of ocular surgery is noninferior to dexamethasone eye drops in the treatment of postoperative ocular inflammation.
Department of Ophthalmology, University Hospital, Grenoble, France. Electronic address: christophe.chiquet@inserm.fr.
Christophe
C
Chiquet
Department of Ophthalmology, University Hospital, Grenoble, France.
Florent
F
Aptel
Department of Ophthalmology, University Hospital Dijon, Dijon, France.
Catherine
C
Creuzot-Garcher
Department of Ophthalmology, University Hospital Nancy-Brabois, Vandoeuvre-lès-Nancy, France.
Jean-Paul
JP
Berrod
Department of Ophthalmology, Hôpital de la Croix Rousse, Lyon, France.
Laurent
L
Kodjikian
Department of Ophthalmology, Hôpital Lariboisière, Paris, France.
Pascale
P
Massin
Solid Drug Development SA, Genève, Switzerland.
Catherine
C
Deloche
Solid Drug Development SA, Genève, Switzerland.
Julien
J
Perino
SOCAR Research SA, Nyon, Switzerland.
Bridget-Anne
BA
Kirwan
SOCAR Research SA, Nyon, Switzerland.
Sophie
S
de Brouwer
Solid Drug Development SA, Genève, Switzerland.
Jean-Marc
JM
Combette
Department of Ophthalmology, Assistance Publique-Hôpitaux Paris, Hôpital Hôtel-Dieu, Paris, France.
Francine
F
Behar-Cohen
D003228:Conjunctiva; D003907:Dexamethasone / Q000008:administration & dosage* / Q000493:pharmacokinetics; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage / Q000493:pharmacokinetics; D006801:Humans; D007267:Injections; D008297:Male; D018696:Neuroprotective Agents / Q000008:administration & dosage / Q000493:pharmacokinetics; D009883:Ophthalmic Solutions; D013508:Ophthalmologic Surgical Procedures / Q000009:adverse effects*; D010455:Peptides / Q000008:administration & dosage* / Q000493:pharmacokinetics; D011183:Postoperative Complications / Q000188:drug therapy* / Q000209:etiology / Q000378:metabolism; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014606:Uveitis, Anterior / Q000188:drug therapy* / Q000209:etiology / Q000378:metabolism
D005938:Glucocorticoids; D018696:Neuroprotective Agents; D009883:Ophthalmic Solutions; D010455:Peptides; D003907:Dexamethasone; C478085:D-JNKI-1