Title:Topical Bimatoprost Insert for Primary Open-Angle Glaucoma and Ocular Hypertension Treatment - A Phase II Controlled Study
VOLUME: 18
Author(s):Francine Rubião*, Alan Cezar Faria Araújo, João Bernardo Sancio, Bárbara Silva Nogueira, Juçara Ribeiro Franca, José Carlos Nogueira, Anderson José Ferreira, André Augusto Gomes Faraco, Giselle Foureaux and Sebastião Cronemberger
Affiliation:Medical School, Universidade Federal de Minas Gerais, Medical School, Universidade Federal de Minas Gerais, Medical School, Universidade Federal de Minas Gerais, Medical School, Universidade Federal de Minas Gerais, Department of Pharmaceutical Products, Universidade Federal de Minas Gerais, Department of Morphology, Universidade Federal de Minas Gerais, Department of Morphology, Universidade Federal de Minas Gerais, Department of Pharmaceutical Products, Universidade Federal de Minas Gerais, Department of Morphology, Universidade Federal de Minas Gerais, Department of Ophthalmology and Otorhinolaryngology, Universidade Federal de Minas Gerais
Keywords:Glaucoma, ophthalmic insert, sustained-release drug, chitosan, bimatoprost, drug delivery
Abstract:Background: The most common treatment for primary open-angle glaucoma (POAG) is the daily use of eye
drops. Sustained-release drug delivery systems have been developed to improve patient adherence by achieving prolonged
therapeutic drug concentrations in ocular target tissues while limiting systemic exposure. The purpose of this study is to
compare the efficacy and safety of bimatoprost inserts with bimatoprost eye drops in patients with POAG and ocular
hypertension (OH).
Methods: We include OH and POAG patients aged between 40 and 75 years-old. Both OH and POAG patients had
intraocular pressure (IOP) greater than 21 and ≤30 mmHg at 9:00 am without glaucoma medication and normal
biomicroscopy. Five normal patients with IOP≤14 mmHg constitute the control group. A chitosan-based insert of
bimatoprost was placed at the upper conjunctival fornix of the right eye. In the left eye, patients used one drop of
LumiganTM daily at 10:00 pm. For statistical analysis, we used a two-way analysis of variance (ANOVA), Student t-test,
and paired t-test.
Results: Sixteen POAG and 13 OH patients with a mean age of 61 years were assessed. In both eyes, IOP reduction was
similar during three weeks of follow-up (19.5±2.2 mmHg and 16.9±3.1 mmHg), insert, and eye drop, respectively;
P=0.165). The percentage of IOP reduction in the third week was 30% for insert and 35% for eye drops (P=0.165). No
intolerance or discomfort with the insert was reported. Among the research participants, 58% preferred the use of the insert
while 25% preferred eye drops, and 17% reported no preference.
Conclusions: Bimatoprost-loaded inserts showed similar efficacy to daily bimatoprost eye drops during three weeks of
follow up, without major side effects. This might suggest a possible change in the daily therapeutic regimen for the
treatment of POAG and OH.
