MediPrint™ Ophthalmics Announces Successful Completion of Its SIGHT-1 Phase 2a Clinical Study
First-in-human Trial with Novel Glaucoma Treatment Confirmed Favorable Safety Profile and Signaled Efficacy
SAN DIEGO--(BUSINESS WIRE)-- Today, MediPrint™ Ophthalmics, an emerging San Diego-based clinical stage eye care pharmaceutical company focused on helping protect sight, announces the successful completion of the first study in its SIGHT (Sustained Innovative Glaucoma and ocular Hypertension Treatment) clinical program aimed at treating mild to moderate glaucoma and ocular hypertension. SIGHT-1 evaluated the Company’s lead asset, a unique and complete glaucoma treatment, in human eyes for the first time. This initial trial achieved its objectives by showing a favorable safety and tolerability profile and extended beyond its intended aims by demonstrating an efficacy signal from a single dose.
In SIGHT-1, MediPrint Ophthalmics’ lead asset, LLT-BMT1, a drug-eluting contact lens to treat glaucoma, was administered to five (5) patients in a trial designed following discussions with the FDA. The study subjects, whose average age was 77.4 years old and who had not previously worn contact lenses, wore an LLT-BMT1 lens in each eye for seven (7) days continuously during which the treatment regimen demonstrated 100% tolerability and no significant adverse events, confirming its safety profile. Bimatoprost is the FDA-cleared drug printed on the contact lens with the proprietary MediPrint process and, notably, the incidence of hyperemia detected in SIGHT-1 was lower than that observed for bimatoprost drops, one of today’s standards of care.
SIGHT-1 findings also included an efficacy signal from a single dose, which was not one of the study design’s planned endpoints. However, this indicator encourages the Company to proceed swiftly with SIGHT-2, a Phase 2b dose-ranging clinical study intended to optimize dosage for efficacy. SIGHT-2 will be a larger trial and will be followed by an even broader Phase 3 study, SIGHT-3.
“I was excited to study this investigational treatment and believe that LLT-BMT1’s unique product presentation and potential benefits differentiate it from other glaucoma treatments currently on the market,” commented Dr. David Wirta, the Eye Research Foundations’ Medical Director and SIGHT-1’s principal investigator. “Further, this initial clinical trial establishes an encouraging foundation for future studies to confirm LLT-BMT1’s potential benefits for glaucoma patients. The results of the SIGHT-1 study clearly point to LLT-BMT1’s ability to progress to the next step in its clinical program, during which dose optimization can occur.”
“We are encouraged by the results of the SIGHT-1 study because they validated the MediPrint™ process and contact lenses for treating human subjects, allowing our company to advance a number of assets in our pipeline to help protect sight for patients suffering from conceivably disabling eye diseases like glaucoma,” said Dan Myers, CEO of MediPrint Ophthalmics. “Additionally, between confirming LLT-BMT1’s tolerability and safety and observing a meaningful efficacy signal from a single dose, we are enthusiastic to optimize dosage in our pending SIGHT-2 Phase 2b study and are confident we are on the right path to a successful SIGHT-3 Phase 3 trial. We are grateful to Dr. Wirta and the patients involved in the SIGHT-1 study and I am proud of our MediPrint Ophthalmics team for achieving our most significant milestone to date.”
About MediPrint™ Ophthalmics
MediPrint™ Ophthalmics (formerly Leo Lens Pharma) is an emerging San Diego-based clinical stage eye care pharmaceutical company focused on helping protect sight by developing and commercializing a proprietary 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 and for allergy, and subsequently for other anterior and posterior segment conditions. Using its proprietary MediPrint process, MediPrint Ophthalmics will initially commercialize a drug-eluting, comfort-enhancing, preservative-free 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. MediPrint Ophthalmics’ patented MediPrint process offers a unique value proposition for patients, practitioners, strategic partners, and payers.
For more information, please visit www.mediprintlens.com.
Source: MediPrint Ophthalmics, Inc.