MediPrint Ophthalmics (MediPrint), a clinical-stage ophthalmic drug delivery company based in San Diego, announced the results of the company’s phase 2b clinical trial of LL-BMT1.
Employing a novel 3D printed, drug-eluting contact lens for sustained delivery of bimatoprost and hyaluronic acid, the clinical trial achieved all phase 2b endpoints.
In a presentation by Ian Ben Gaddie, OD, at the American Academy of Optometry’s annual meeting in Indianapolis, the results highlighted the potential of LL-BMT1 as an innovative solution to manage mild to moderate glaucoma while improving contact lens comfort through the reduction of dry eye symptoms.
The study demonstrated that the 32-µg dose of LL-BMT1 achieved equivalence to the efficacy of bimatoprost 0.01% in reduction of intraocular pressure (IOP). Patients with LL-BMT1 only required six lens insertions over three weeks—an 86% reduction in treatment frequency compared to traditional daily eye drops. This significant reduction in dosing frequency underscores the potential for LL-BMT1 to improve patient compliance and outcomes in glaucoma management.
Enhanced comfort and eye health with sustained hyaluronic acid delivery
The study also found that LL-BMT1 lenses, which incorporate hyaluronic acid for sustained comfort, significantly improved patient-reported comfort and relief from dry eye symptoms. For subjects within the chosen dose range, comfort and dry eye symptoms improved by approximately 38% and 40% respectively.
These results indicate that LL-BMT1 not only provides therapeutic benefits but also enhances wearability, making it potentially suitable for weekly and extended wear use.
Safety and tolerability confirmed in phase 2b trial
Safety data from the phase 2b study was favorable, with preservative-free LL-BMT1 lenses found to be safe and well-tolerated among all participants. No serious adverse events were reported in either cohort, affirming LL-BMT1 as a promising alternative to traditional eye drop treatments for glaucoma patients.
“LL-BMT1 represents a potential major step forward in glaucoma care, offering an effective, less burdensome alternative to daily eye drops and a less invasive option to laser or surgical modalities” said Dr. Gaddie.
Looking ahead: phase 3 study and market approval in 2025
With these results, MediPrint plans to move forward with two programs in 2025, one focusing on comfort improvement, with hyaluronic acid (HA), in the daily disposable lens market and second, initiating the Phase 3 clinical study of LL-BMT1 for glaucoma.
By offering a solution that enhances bioavailability, minimizes side effects, and is more convenient for patients, LL-BMT1 aims to transform the management of ocular hypertension and mild to moderate glaucoma.
“Our clinical study results demonstrate that LL-BMT1 could offer a highly effective and patient-friendly alternative to daily eye drops, particularly for glaucoma patients who struggle with treatment adherence,” said Praful Doshi, founder and CEO of MediPrint Ophthalmics. “We’re excited to advance this technology through phase 3 trials to bring a new standard of care to the glaucoma community, as well as move our comfort program forward for the millions of patients who discontinue contact lens wear due to discomfort .”