Sustained Release Intravitreal Corticosteroid Injections

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DESCRIPTION (provided by applicant): The long term goal of this research is to reduce or eliminate blindness due to diseases of the back of the eye by developing sustained release intravitreal injectable formulations for anti-inflammatory drugs. In previous work, supported in part through SBIR Phase 1 and 2 funding, the Principal Investigator has developed the Vitrasert(r) sustained release implant approved by the FDA for the treatment of CMV retinitis in 1995, and the Retisert(tm) sustained release implant currently under NDA review by the FDA. The specific aims of this application are to: 1, formulate sustained release suspensions of fluocinolone acetonide; 2, test the in vitro release characteristics of these formulations into buffer; and 3, test the in vivo pharmacokinetics and the safety of the formulations after intravitreal injection in the rabbit. The team of investigators is expert in polymer chemistry, pharmacokinetics and drug development. We have experience in all aspects of the drug development process, from concept to approval and marketing. The successful completion of these specific aims will constitute a readily identifiable milestone which will permit us to continue with Phase 2 of this application where we will test the efficacy of the devices in animal models of posterior uveitis and complete the requisite laboratory work to apply for an Investigational New Drug Exemption from the FDA.