SAN DIEGO--(BUSINESS WIRE)--Today, Leo Lens Pharma, an emerging San Diego-based pharmaceutical company focused on helping protect sight, is pleased to announce 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 one week. After a productive Pre-IND meeting with the FDA, Leo Lens has now successfully 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. 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 intraocular pressure (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,” commented 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,” he added.
About Leo Lens Pharma
Leo Lens Pharma (Leo Lens) is an emerging San Diego-based pharmaceutical company focused on helping protect sight. Using its proprietary MediPrint™ process, the Company will commercialize a drug-eluting, comfort-enhancing contact lens to treat millions of glaucoma patients worldwide. While eye drops have been around for over 40 years and remain the standard of care for over 90% of patients, they have only around a 50% compliance rate. This leads millions to suffer from disease progression and thousands to suffer from preventable blindness. There is a large unmet need for a better non-invasive treatment option in this $4B US market. Leo Lens’ patented MediPrint™ process offers a unique value proposition for patients, practitioners, strategic partners, and payers. Leo Lens is currently focused on advancing its lead asset, a unique and complete glaucoma treatment, to the clinic while continuing to build out its product pipeline for dry eye, allergy, and other anterior segment conditions.
For more information please visit www.leolens.com.