IND Paves the Way to Phase 2a Clinical Study and Seed Round Lead Advances Company’s Efforts for Its Proprietary Continuous Ocular Drug Delivery Portfolio
FOR IMMEDIATE RELEASE
SAN DIEGO, CA, USA (Business Wire, November 12th, 2020) – Today, Leo Lens Pharma, an emerging San Diego-based pharmaceutical company focused on helping protect sight, announces the achievement of two significant milestones. The first is the filing in the United States of the Food and Drug Administration’s (FDA’s) Investigational New Drug (IND) application for its lead asset, a proprietary drug-eluting, comfort- enhancing contact lens to treat patients suffering from primary open-angle glaucoma or ocular hypertension. The second is the securement of a lead investor, the venture arm of a leading global ophthalmic pharmaceutical company, and initial funding in its Seed round fundraising efforts.
The U.S. FDA’s IND program charts the path by which a pharmaceutical company such as Leo Lens Pharma obtains permission to start human clinical trials before a marketing application for the drug has been approved. The Company’s IND submission is a key step toward being able to start its first human clinical trial with its lead asset, LL-BMT1, to treat primary open-angle glaucoma and ocular hypertension. Current plans are for the first patients in this Phase 2a clinical trial to be enrolled in the coming months.
The strategic lead investor in the Seed round fueled an initial close of the round that exceeded $3 million with $1.5 million coming from new investors. There will be a subsequent close of this round, likely before year-end, when the round is fully or over-subscribed. The funds raised in this round are targeted primarily to support the Phase 2a clinical study along with the end of Phase 2 meeting with the FDA.
“We are enthused to have executed against two pivotal goals that poise Leo Lens Pharma to continue to move forward successfully,” said Dan Myers, CEO of Leo Lens Pharma. “The IND submission step, which gets us closer to beginning our first in-human clinical study, is monumental. We are also excited that our Seed round strategic lead investor has placed their belief in us after significant due diligence to continue to advance our efforts to help glaucoma and ocular hypertension patients protect their sight. We are encouraged too by the excitement from other investors interested in the remaining portion of the round,” he elaborated.
About Leo Lens Pharma
Leo Lens Pharma (Leo Lens) is an emerging San Diego-based pharmaceutical company focused on helping protect sight by developing and commercializing a proprietary continuous ocular drug delivery portfolio. The Company is currently advancing its lead asset, a unique and complete glaucoma treatment, to the clinic while continuing to build out its product portfolio for dry eye, allergy, and other anterior segment conditions. Using its proprietary MediPrint™ process, Leo Lens will initially 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 U.S. market. Leo Lens’ patented MediPrint™ process offers a unique value proposition for patients, practitioners, strategic partners, and payers.
For more information please visit www.leolens.com.
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