- Completed dose-finding, multi-center, active-controlled, randomized Phase IIb study for bimatoprost eluting Contact lens in open-angle Glaucoma patients.
- Results show clinically meaningful and sustained IOP reduction over the duration of 3 weeks which is statistically comparable to 0.01% bimatoprost eye drops.
- Company is planning for its EOPII meeting with FDA and gearing for Phase III program.
MediPrint Ophthalmics announced the completion of its glaucoma SIGHT-2, phase 2b study.
The Phase IIb trial was an active-controlled, randomized, dose-finding, multi-center study, evaluating the company’s lead candidate (LL-BMT1) versus a control group on bimatoprost 0.01% ophthalmic solution.
LL-BMT1 is a novel, preservative-free, weekly drug-eluting contact lens leveraging company’s proprietary 3D printing technology. SIGHT-2 study evaluated safety and efficacy of LL-BMT-1 in 28 patients diagnosed with open-angle glaucoma for three weeks.
Both groups achieved sustained reduction of about 30% from the baseline IOP which is comparable to the reported literatures of Lumigan 0.01% eye drops. There were no serious treatment emergent adverse events reported and the lenses were well tolerated. An evaluation of dry eye and end of the day comfort for contact lens carried out per CLDEQ-8 questionnaire also showed significant improvements in dry eye and contact lens comfort.
Houman Hemmati, MD, PhD, a member of the Scientific Advisory Board at MediPrint Ophthalmics, is excited about the new clinical data, "We are pleased with thephase 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."
“The successful completion of the study is an important milestone as it validates our company’s technology and will help address significant unmet need for patients suffering from glaucoma or ocular hypertension. We are looking forward to progressing this product to phase 3 while actively developing our pipeline of other ophthalmic products. Improving end of the day comfort and dry eye are our next two products inline.” said Praful Doshi, founder and CEO of MediPrint Ophthalmics.
The company has developed a scalable manufacturing process at its facility in San Diego and plans to approach the FDA with the end of phase 2 meeting and progress this product to phase 3. The company looks to share the details of the data at the upcoming meetings.