24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients
| Autor: | E. Randy Craven, Douglas G. Day, Marina Bejanian, Michael R. Robinson, Richard A. Lewis, Margot L. Goodkin, Michelle Y. Chen, William C. Christie, Thomas R Walters, Veronica Wangsadipura |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Intraocular pressure Time Factors genetic structures Glaucoma 03 medical and health sciences 0302 clinical medicine Ophthalmology Absorbable Implants medicine Clinical endpoint Humans Pharmacology (medical) Original Research Article Prospective Studies Prospective cohort study Adverse effect Antihypertensive Agents Intraocular Pressure Aged Bimatoprost Dose-Response Relationship Drug business.industry Middle Aged medicine.disease eye diseases Prostaglandin analog Treatment Outcome 030220 oncology & carcinogenesis Female Implant sense organs Injections Intraocular business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Drugs |
| ISSN: | 1179-1950 0012-6667 |
| Popis: | Objective The objective of this study was to evaluate the safety and intraocular pressure (IOP)-lowering effects over 24 months of biodegradable bimatoprost sustained-release implant (Bimatoprost SR) administration versus topical bimatoprost 0.03% in patients with open-angle glaucoma (OAG). Methods This was a phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial. At baseline following washout, adult patients with OAG (N = 75) received Bimatoprost SR (6, 10, 15, or 20 µg) intracamerally in the study eye; the fellow eye received topical bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or single repeat administration with implant was permitted. The primary endpoint was IOP change from baseline. Safety measures included adverse events (AEs). Results At month 24, mean IOP reduction from baseline was 7.5, 7.3, 7.3, and 8.9 mmHg in eyes treated with Bimatoprost SR 6, 10, 15, and 20 µg, respectively, versus 8.2 mmHg in pooled fellow eyes; 68, 40, and 28% of pooled study eyes had not been rescued/retreated at months 6, 12, and 24, respectively. AEs in study eyes that occurred ≤ 2 days post-procedure typically were transient. After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes. Conclusions Bimatoprost SR showed favorable efficacy and safety profiles up to 24 months, with all evaluated dose strengths demonstrating overall IOP-reducing effects comparable to those of topical bimatoprost. Targeted and sustained delivery of bimatoprost resulted in protracted IOP lowering, suggesting that Bimatoprost SR may represent a transformational new approach to glaucoma therapy. Clinicaltrials.gov identifier: NCT01157364 Electronic supplementary material The online version of this article (10.1007/s40265-019-01248-0) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
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