LAYERBIO INC — Department of Health and Human Services SBIR Phase II: NEI

Description

PROJECT SUMMARY Glaucoma affects overmillion peopleIt is the leading cause of irreversible blindness worldwideEye drop medications are available for treatment of glaucomahowevernearly half of all glaucoma patients do not fully comply with their prescribed eye drop regimensand many continue to lose vision in spite of available therapyThere is a significant need for sustained release drug delivery systems to guarantee medication compliance and reduce the risk of vision loss from glaucomaLayerBio is developing a sustained release glaucoma implant that delivers an existing FDA approved drug directly inside the eyeLayerBio has already demonstrated feasibility of this approach in terms of manufacturability and efficacy in a validated preclinical modelWe have also consulted the FDA and obtained guidance regarding the appropriate regulatory pathway for product approval and the appropriate preclinical ocular pharmacokineticsPKand toxicology studies necessary to file an IND prior to initiation of clinical trialsCompletion of these IND enabling studies is the subject of this PhaseSBIR grant PROJECT NARRATIVE There is a critical need to improve compliance with glaucoma therapiesThis application seeks to address this need through development of a sustained release intraocular implant that delivers glaucoma medication locally within the eye thereby obviating the need for topical eye dropsSuch a product has the potential to improve outcomes for patients with glaucoma and reduce societal costs associated with vision loss among glaucoma patients