MediPrint Ophthalmics Announces Completion of SIGHT-1 Phase 2a Clinical Study

Source: MediPrint Ophthalmics

MediPrint Ophthalmics announced 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 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,” David Wirta, MD, the Eye Research Foundations’ Medical Director and SIGHT-1’s principal investigator, said in a company news release. “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.”

For more information, please visit www.mediprintlens.com.

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