Human Trial with Novel Glaucoma Treatment Rendered a Clinically Meaningful Efficacy Outcome and Positive Safety and Tolerability Data
SAN DIEGO–(BUSINESS WIRE)–Today, MediPrint® Ophthalmics (MediPrint), an emerging San Diego-based clinical stage eye care pharmaceutical company focused on enhancing vision for life, announces it has completed its SIGHT-2 dose-finding Phase 2b Group 1 (low dose) study for its proprietary drug-eluting contact lens for glaucoma. This is the first of potentially three doses in the second study of its clinical program SIGHT (Sustained Innovative Glaucoma and ocular Hypertension Treatment) for LL-BMT1, a preservative-free weekly medicated contact lens releasing bimatoprost to treat open angle glaucoma and ocular hypertension. SIGHT-2 is designed to assess dose optimization for the Company’s lead asset, LL-BMT1, and was preceded by the successful completion of the Company’s SIGHT-1 study that validated the MediPrint process and contact lenses for treating human subjects.
In the SIGHT-2 Group 1 study, MediPrint’s LL-BMT1 (low dose) was administered to 11 patients, whose average age was 52.0 years old and who had not previously worn contact lenses, for a duration of three (3) weeks. The study subjects wore a new LL-BMT1 (low dose) lens in each eye for seven (7) days continuously for three (3) consecutive weekly lens insertion cycles (21 days total). There was also a reference arm in the clinical trial in which the study subjects used timolol 0.5% topical eye drops twice a day for three (3) weeks.
An interim analysis of the SIGHT-2 Group 1 results for efficacy shows that the LL-BMT1 (low dose) lens achieved a clinically meaningful reduction in Intraocular Pressure (IOP) of about 5.5 mmHg and was comparable to the reference treatment. There was a sharp decline in IOP in the first week (-14% from baseline) with the LL-BMT1 (low dose) lens, IOP declined further in the second week (-18% from baseline) and in the third week (-19% from baseline) too. The low IOP was maintained with minimal fluctuation for the three-week study duration. The interim analysis results for safety and tolerability show that there were no serious treatment emergent adverse events (TEAEs) reported and the lenses were well tolerated. Also, as a result of its simultaneous release of lubricant HA, there were no protein deposits on lenses and comfort improved over the study duration.
The SIGHT-2 Phase 2b Group 1 results trajectory is positive and promising. The SIGHT-2 Phase 2b Group 2 study is planned with the LL-BMT1 (medium dose) lens. Its objective is to see a higher reduction in IOP.
“I am enthusiastic about the SIGHT-2 Phase 2b Group 1 clinical study results because they indicate that the path to get to our Phase 3 study and to an FDA approval is clear and achievable,” commented Praful Doshi, Founder, Chairman, and Interim CEO. “We realize we need to move to the LL-BMT1 medium dose lens in the SIGHT-2 Phase 2b Group 2 study, since a higher IOP drop is anticipated at a higher dose per contact lens. I also want to thank our MediPrint® team and our CRO partner, CBCC, who continue to strive every day to help fulfill eye care professionals’ and patients’ desire to find an alternative to administering ophthalmic drops.”
About MediPrint® Ophthalmics
MediPrint® Ophthalmics is an emerging San Diego-based clinical stage eye care pharmaceutical company focused on enhancing vision for life by developing and commercializing a proprietary contact lens based ocular drug delivery portfolio. There are over 40 million soft contact lens wearers in the United States alone and most of them will develop some eye disease or condition in their lifetime. Treating their disease or condition with eye drops is inconvenient and frustrating, leading millions to become non-compliant or to be forced to drop out of contact lens wear. The Company’s goal is to offer new treatment options that allow millions of patients to continue wearing their contact lens while the lens correcting their vision also delivers drugs to treat their underlying disease or condition. The Company is currently advancing its lead asset, a unique and complete glaucoma treatment, to the clinic while continuing to build out its product portfolio for dry eye and for allergy, and subsequently for other anterior and posterior segment conditions. Approximately 5% of glaucoma patients in the United States wear contact lenses and MediPrint’s innovative drug-eluting, comfort-enhancing, preservative-free contact lens may be an ideal treatment option for them. MediPrint Ophthalmics’ patented MediPrint process offers a unique value proposition for patients, practitioners, strategic partners, and payers.
For more information, please visit www.mediprintlens.com.
About CBCC Global Research™
CBCC Global Research is a full-service, specialty contract research organization offering a wide variety of clinical research services for the advancement of clinical development programs in Ophthalmology, Oncology, Neurology, Psychiatry and other therapeutic areas. CBCC offers end-to-end services for clinical trials, including clinical operations, site management, safety management, clinical data management & statistical analysis and medical & scientific writing.
For more information, please visit www.cbcc.global.