Glaucoma affects over 60 million people. It is the leading cause of irreversible blindness worldwide. Eye drop medications are available for treatment of glaucoma; however, nearly half of all glaucoma patients do not fully comply with their prescribed eye drop regimens, and many continue to lose vision in spite of available therapy. There is a significant need for sustained-release drug delivery systems to guarantee medication compliance and reduce the risk of vision loss from glaucoma. LayerBio is developing a sustained-release glaucoma implant that delivers an existing FDA-approved drug directly inside the eye. LayerBio has already demonstrated feasibility of this approach in terms of manufacturability and efficacy in a validated preclinical model. We have also consulted the FDA and obtained guidance regarding the appropriate regulatory pathway for product approval and the appropriate preclinical ocular pharmacokinetics (PK) and toxicology studies necessary to file an IND prior to initiation of clinical trials. Completion of these IND-enabling studies is the subject of this Phase 2 SBIR grant.
There is a critical need to improve compliance with glaucoma therapies. This 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 drops. Such a product has the potential to improve outcomes for patients with glaucoma and reduce societal costs associated with vision loss among glaucoma patients.
|Mandell, Kenneth J; Kudelka, Matthew R; Wirostko, Barbara (2011) Rho kinase inhibitors for treatment of glaucoma. Expert Rev Ophthalmol 6:611-622|