Purchase this article with an account.
Michael M Burr, Sarah Molokhia, Balamurali Ambati; Evaluation of the Biocompatibility of a New Dexamethasone Implant in the Rabbit Eye (GLP study). Invest. Ophthalmol. Vis. Sci. 2016;57(12):4014.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
To evaluate the biocompatibility and safety of a new bioerodible dexamethasone implant (IVMED-20) allowing for sustained release of dexamethasone, after implantation within the capsular bag in rabbit eyes.
The study will be conducted in accordance with the requirements of the Food and Drug Administration (FDA) Good Laboratory Practices (GLP) regulations. The study includes 60 eyes of 38 rabbits. The New Zealand white rabbits used in this study will undergo endocapsular cataract extraction by phacoemulsification with intraocular lens (IOL; HOYA iSert® 231 Yellow Preloaded IOL System; power range: +16.0 to +24.0 D) placement within the capsular bag. There will be three groups of eyes evaluated in this study: The first test group (low dose) will have implantation of 1 IVMED-20 implant; the second test group (high dose) will have implantation of 2 IVMED-20 implants; the control group will receive topical dexamethasone drops. The rabbits will then be followed at regular intervals postoperatively to evaluate reactions up to 10 weeks. The rabbits will subsequently be sacrificed and pathological evaluation will be performed.
All test rabbit eyes receiving either 1 or 2 implants were quiet for the entirety of the study. The IVMED-20 remained in the lens capsule for the duration of study. No histopathological test article related changes were observed in rabbit eye tissues.
The IVMED-20 is a bioerodible implant containing dexamethasone as the active ingredient, designed to release the drug for approximately 6 weeks after implantation in the inferior fornix of the lens capsular bag following cataract surgery in patients at elevated risk of cystoid macular edema (e.g., patients with diabetes, uveitis). IVMED-10 is a lower dexamethasone dose used for routine postcataract inflammation. Toxicokinetic and other toxicology parameters were collected and are currently being analyzed. The successful outcome of this GLP study will support an IND submission for Phase 1/2a clinical trial.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
This PDF is available to Subscribers Only