Leo Lens Pharma has announced that its lead asset, LL-BMT1, is ready for IND submission and human clinical evaluation. LL-BMT1 is a therapeutic contact lens that delivers preservative-free bimatoprost to the eye to treat glaucoma for 1 week. After a pre-IND meeting with the FDA, Leo Lens has now completed GLP biocompatibility studies required by the FDA, secured a clinical research organization to oversee the initial human clinical trial, secured the clinical site, and executed an agreement with a contract manufacturing organization for cGMP manufacturing of the clinical test articles, according to a company news release. The company plans to submit an IND in the coming months and proceed to phase 2a clinical evaluation of LL-BMT1 in 2020.
Leo Lens Pharma has developed the MediPrint process, a proprietary printing technology that allows for the sustained, continuous release of ophthalmic drugs via FDA-approved contact lenses as the drug delivery system. For LL-BMT1, FDA approved bimatoprost is digitally printed onto the anterior surface of the contact lens. This product is designed to reduce elevated IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). LL-BMT1 is a novel product intended to continuously deliver bimatoprost, even while sleeping, to treat OAG and OHT. It has the potential to reduce the progression of glaucoma and the rate of vision loss in patients with glaucoma, due to better patient compliance, less IOP fluctuation, and reduced side effects compared to treatment with eye drops.
“I am impressed by the quality and expertise of the Leo Lens R&D team as we continue to strive to deliver the future of eye care,” said Dan Myers, CEO of Leo Lens Pharma. “I am also confident in our ability to conduct a successful clinical study once the IND is filed. Concurrently, the strong reception we have received from the investment community to date has been encouraging and the momentum we have achieved excites me for what is to come the remainder of the year.”