Integral Biosystems, LLC — Department of Health and Human Services SBIR Phase I: B

Description

DESCRIPTION provided by applicant We propose the development of a novel self administered preservative free sustained release Travoprost containing drug product for the treatment of glaucoma One of the leading causes for visual impairment and blindness among the elderly is glaucoma and is due to progressive damage to the retina and the optic nerve Eye drops are widely used to deliver medications directly to the ocular surface Eye drops are administered by the patient and are relatively inexpensive products However eye drops have significant limitations especially when utilized for chronic diseases or when requiring frequent administrations The limitations include lack of patient compliance inefficient placement of the drop and losses of approximately of the dosage by naso lacrimal drainage requiring higher than efficacious concentrations be administered Thus of significant benefit to patients would be a self administered preservative free sustained release prostaglandin drug product delivered as a controlled sustained rate of lower but efficacious concentrations of the requisite drug Integral BioSystems scientists have invented a bioengineered sustained release prostaglandin containing product that can be placed in the conjunctival cul de sac by the patient every days The drug containing device will be designed to adhere to the ocular tissue immediately after placement The target product profile of our initial prototype is comprised of Travoprost incorporated in biocompatible biodegradable and mucoadhesive polymers specifically designed to release intact drug from a flexible conforming mesh over a period of days while bioabsorbing into the local tissue The nanomesh will be tailored to sufficiently biodegrade by days providing the space for the next placement In vitro release studies will also assess integrity of the encapsulated drug as the product biodegrades This innovation if clinically validated to be a safe and effective glaucoma product can potentially transform how other medications are administered to the ocular surface and the anterior chamber of the eye for other chronic as well as acute diseases PUBLIC HEALTH RELEVANCE One of the leading causes for blindness among the elderly is glaucoma Among the leading lines of therapies for glaucoma are prostaglandin eye drops administered once daily However treatment is confounded by lack of patient compliance inefficient placement of the drop and losses of approximately of the dosage to drainage by the tear duct Additionally most glaucoma medications contain preservatives that with chronic use cause ocular irritation We propose the development of a novel self administered preservative free sustained release biodegradable Travoprost containing product that can be placed in the conjunctival cul de sac by the patient every days