■ MediPrint Ophthalmics has completed the low-dose portion of its SIGHT-2 dose-finding phase 2b study of a bimatoprost-eluting contact lens for glaucoma. The company stated it is evaluating 3 potential preservative-free doses in its clinical program.
The medicated contact lens to treat open-angle glaucoma and ocular hypertension was administered to 11 patients for 3 weeks. The study subjects wore a new low-dose lens in each eye for 7 days continuously for 3 consecutive weekly lens insertion cycles. The reference arm group received timolol 0.5% drops twice a day for 3 weeks.
An interim analysis showed that the low-dose lens achieved a clinically meaningful reduction in intraocular pressure (IOP) of about 5.5 mmHg and was comparable to the reference treatment. Low IOP was maintained with minimal fluctuation for the study duration and there were no serious treatment-emergent adverse events. The lenses were well tolerated, the company reported in a news release.
“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,” said Praful Doshi, founder, chairman, and interim CEO.