MediPrint Ophthalmics announced positive results from its phase 2b clinical trial of its 3D-printed, drug-eluting contact lens LL-BMT1. The results, presented by Ian Ben Gaddie, OD, FAAO, at the American Academy of Optometry’s annual meeting in Indianapolis, demonstrate LL-BMT1’s potential as a solution for managing mild to moderate glaucoma, while also improving comfort for contact lens wearers by reducing dry eye symptoms. The sustained-release system combines bimatoprost with hyaluronic acid for added moisture.
The study demonstrated that the 32-µg dose of LL-BMT1 achieved equivalence to the efficacy of bimatoprost 0.01% in reduction of IOP. Patients with LL-BMT1 only required six lens insertions over 3 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.
“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,” Ian Ben Gaddie, OD, FAAO, said in a company news release. “These results are truly encouraging for both patients and practitioners seeking better treatment options.”
In addition to its efficacy in reducing IOP, LL-BMT1 lenses were designed to enhance patient comfort by incorporating hyaluronic acid, known for its hydrating properties. The study revealed that patients reported a 38% improvement in comfort and a 40% reduction in dry eye symptoms after wearing the lenses, indicating that LL-BMT1 could potentially support weekly and extended wear use.
The Phase 2b trial also provided strong safety data. The preservative-free LL-BMT1 lenses were well-tolerated by all participants, with no serious adverse events reported, according to MediPrint.
“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.”
With these Phase 2b results, MediPrint plans to initiate two major programs in 2025. The first will focus on comfort enhancement using hyaluronic acid in daily disposable lenses, while the second will begin the phase 3 clinical study of LL-BMT1 for glaucoma treatment. The company aims to bring LL-BMT1 to market by 2025.