MediPrint Ophthalmics announced the completion of its SIGHT-2 dose-finding, phase 2b, group 1 (low-dose) study of its lead asset LL-BMT1—a proprietary and drug-elution contact lens for the treatment of open-angle glaucoma (OAG) and ocular hypertension (OHT).
Give me details on LL-BMT1.
LL-BMT1 is designed to be a weekly medicated, preservative-free, extended-wear contact lens that releases bimatroprost, which is printed directly on the lens—an ocufilcon D soft hydrophilic contact lens—via MediPrint Ophthalmics’ proprietary inkjet printer.
The drug-eluting lens is currently being assessed in the company’s Sustained Innovative Glaucoma and ocular Hypertension Treatment (SIGHT) clinical program, which includes the completed SIGHT-1 study (NCT04747808).
What happened in the SIGHT-1 trial?
LL-BMT1 demonstrated a favorable safety profile, with 100% tolerability and no significant adverse events from a single dose.
As an added bonus, findings also included an efficacy signal from a single dose—which was not one of the study’s planned endpoints.
Now talk about this phase 2b, group 1 trial.
The SIGHT-2 dose-finding trial administered one low dose of LL-BMT1 (of potentially three doses) to 11 patients (average age of 52 years) with no prior history of contact lens wear for 3 weeks.
Each patient wore a new low-dose LL-BMT1 lens in each eye for 7 days straight for 21 days total (consisting of 3 consecutive weekly lens insertion cycles).
Also of note: a reference arm in the trial included participants using timolol 0.5% topical eye drops twice a day (BID) for 3 weeks.
What’s the data showing so far?
According to the company, LL-BMT1 was well-tolerated with no serious treatment-emergent adverse events (TEAEs).
Further, due to the lenses’ simultaneous release of lubricant hyaluronic acid (HA), the lenses had no protein deposits. Lens comfort also improved over the 3-week period.
What about the IOP?
LL-BMT1 showed a clinically meaningful reduction (5.5 mmHg) in intraocular pressure (IOP) versus a reference drug (timolol 0.5%), which was maintained throughout the study period.
Give me specifics.
IOP sharply declined in the first week by 14% from baseline, and even further in the second week (19% from baseline).
So what’s next?
The company is planning for the SIGHT-2 phase 2b group 2 study, which will assess the use of a medium dose of LL-BMT1.
The goal of the study is to potentially achieve a higher IOP reduction along with finalizing the single dosage of LL-BMT1, which would pave the way for a phase 3 study and a potential FDA approval.
Significance?
LL-BMT1 and other drug-eluting contact lenses have the potential to become an alternative therapeutic option for glaucoma and other ocular diseases, including dry eye disease and seasonal ocular allergies.