MediPrint Ophthalmics (MediPrint) announceD 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 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.”