MediPrint Ophthalmics completes phase 2b trial of drug-eluting contact lens in OAG

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MediPrint Ophthalmics has announced the completion of its glaucoma SIGHT-2, phase 2b study evaluating their LL-BMT1 versus a control group on bimatoprost 0.01% ophthalmic solution. The active-controlled, randomized, dose-finding, multi-center study evaluated the safety and efficacy of LL-BMT1 in 28 patients diagnosed with open-angle glaucoma for 3 weeks.

LL-BMT1 is a novel, preservative-free, weekly drug-eluting contact lens created by the company’s proprietary 3D printing technology.

The study showed both groups achieved a sustained reduction of “about 30% from the baseline IOP which is comparable to the reported literatures of Lumigan 0.01% eye drops.” Furthermore, an evaluation of dry eye and end-of-day comfort with the contact lens, carried out per CLDEQ-8 questionnaire, showed significant improvements in dry eye and contact lens comfort. No serious treatment-emergent adverse events were reported and the lenses were well tolerated.

Houman Hemmati, MD, PhD, member of the Scientific Advisory Board at MediPrint Ophthalmics, stated, “We are pleased with the Phase 2b results showing that our innovative bimatoprost eluting contact lens that also releases the lubricant HA simultaneously not only achieves significant sustained IOP reduction but does so with the promise of enhanced patient comfort, compliance and convenience. This marks a significant leap forward in glaucoma management with contact lenses."

According to the company, it plans to approach the FDA with the End of Phase II meeting and progress LL-BMT1 to phase III.

References:

1. MediPrint® Ophthalmics Announces Successful Completion of Its Phase 2b Glaucoma Clinical Study with Positive Results.. Press release; March 6, 2024. Accessed March 11, 2024. https://www.businesswire.com/news/home/20240306536390/en/MediPrint%C2%AE-Ophthalmics-Announces-Successful-Completion-of-Its-Phase-2b-Glaucoma-Clinical-Study-with-Positive-Results.