SAN DIEGO--(BUSINESS WIRE)--MediPrint® Ophthalmics, a clinical-stage ocular drug delivery platform technology focused on transforming ocular drug delivery, announces 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.
Dr. Houman Hemmati, member of the Scientific Advisory Board at MediPrint Ophthalmics, is excited about the new clinical data, "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."
“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 III 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 II meeting and progress this product to phase III. The company looks to share the details of the data at the upcoming meetings.
MediPrint Ophthalmics stands at the forefront of Ophthalmic innovation as a clinical-stage platform technology company revolutionizing ocular drug delivery. With a steadfast commitment to enhancing vision, our flagship product involves proprietary 3D printing of bimatoprost drug onto contact lenses, delivering sustained relief to patients battling Glaucoma or Ocular Hypertension. Affecting over 100 million individuals globally and more than 8 million in the US alone, Glaucoma and Ocular Hypertension are primarily treated by ophthalmic drops representing significant unmet needs. MediPrint has successfully completed its Phase IIb clinical study. Our robust pipeline is focused on products designed to enhance comfort, alleviate dry eye, and combat various ocular diseases. Based in San Diego, California, MediPrint is not just pioneering change; we are defining the future of ocular drug delivery.
