Drug-eluting contact lens shows potential in first-in-human study
Posted: 17 March 2021 | Hannah Balfour (European Pharmaceutical Review) | No comments yet
The LLT-BMT1 drug releasing contact lens was safe, well tolerated and may have reduced the incidence of hyperaemia in an early glaucoma trial.
The first trial evaluating MediPrint™ Ophthalmics’ lead asset, LLT-BMT1 – a drug-eluting contact lens being developed to treat glaucoma, has been successfully completed.
LLT-BMT1 is a contact lens printed with bimatoprost – a US Food and Drug Administration (FDA)-cleared drug – using MediPrint’s proprietary process.
The trial, the first in the company’s SIGHT (Sustained Innovative Glaucoma and ocular Hypertension Treatment) clinical programme, demonstrated that LLT-BMT1 has a favourable safety and tolerability profile. Additionally, the investigators observed an efficacy signal from a single dose, which the company stated encourages them to “proceed swiftly with SIGHT-2, a Phase IIb dose-ranging clinical study intended to optimise dosage for efficacy”.
In SIGHT-1, LLT-BMT1 was administered to five patients, average age 77.4 years old, who had not previously worn contact lenses. The participants wore an LLT-BMT1 lens in each eye for seven days continuously.
The investigators reported that the treatment demonstrated 100 percent tolerability, with no significant adverse events reported. They also noted that the incidence of hyperaemia in SIGHT-1 was lower than that observed for bimatoprost drops, one of the standard of care treatments for glaucoma and ocular hypertension.
“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 Foundation’s 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, Chief Executive Officer 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 optimise dosage in our pending SIGHT-2 Phase IIb study and are confident we are on the right path to a successful SIGHT-3 Phase III trial.”
Clinical Trials, Drug Delivery Systems, Drug Safety, Medical Devices, Technology, Therapeutics