MediPrint Ophthalmics, Inc. announced it has completed the SIGHT-2 phase 2b study evaluating its LL-BMT1, a proprietary and drug-elution contact lens for the treatment of open-angle glaucoma (OAG) and ocular hypertension (OHT).
Refresh me on this company.
Founded in 2001 and headquartered in San Diego, California, MediPrint (previously known as Leo Lens Pharma) is a clinical-stage eyecare pharmaceutical company dedicated to developing and commercializing a proprietary and non-invasive ocular drug delivery portfolio.
Its areas of focus include: glaucoma, dry eye, post-cataract, ocular comfort enhancement, and ocular allergy. Lead asset: LL-BMT1.
Talk about its science approach.
The company’s proprietary printing technology and ink are incorporated into a drug delivery platform designed for the sustained, continuous release of FDA-cleared ophthalmic drugs via FDA-cleared contact lenses.
Its name: the MediPrint process (click here for a step-by-step look at all five processes).
The intended result: per the company, this is “a novel way to treat various eye diseases and conditions with a non-invasive, cost-effective treatment. “
Now LL-BMT1.
LL-BMT1 is designed as a weekly medicated, preservative-free, extended-wear contact lens that releases bimatroprost—which is printed directly on 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) and SIGHT-2 study.
Before we get to this phase 2 study, what happened in SIGHT-1?
Completed in March 2021, the SIGHT-1 study found that LL-BMT1 demonstrated a favorable safety profile, with 100% tolerability and no significant adverse events from a single dose.
Findings also included an efficacy signal from a single dose—which was notably not one of the study’s intended endpoints. See here for details.
So about SIGHT-2 … weren’t findings already reported?
Yes, back in June 2023. However, those were based on the dose-finding, phase 2b group 1 (low-dose) portion of the active-controlled, randomized, multicenter study.
Quick study recap: The study evaluated LL-BMT1 vs a control group on bimatoprost 0.01% ophthalmic solution. A total of 28 participants (split into two groups) diagnosed with OAG were evaluated for 3 weeks.
Previous findings: LL-BMT1 was found to be well-tolerated with no serious treatment-emergent adverse events (TEAEs).
Further, the asset 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.
Click here for more data.
Now let’s talk new data.
According to MediPrint, “both groups achieved [clinically meaningful and] sustained reduction of about 30% from the baseline IOP,” which was comparable to that of the vehicle (bimatoprost)
Any adverse events?
Nope, no serious TEAEs were reported. In fact, the lenses were noted as being “well tolerated.”
Expert input?
Houman Hemmai, MD, PhD, a clinical advisor on the company’s Scientific Advisory Board, commented on the findings, which showed that LL-BMT1 “not only achieves significant sustained IOP reduction, but does so with the promise of enhanced patient comfort, compliance and convenience.”
And what’s next?
Per MediPrint Ophthalmics’ founder and CEO Praful Doshi, the company is looking to continue LL-BMT1’s development into phase 3 while also actively developing its other ophthalmic products.
With a “scalable manufacturing process at its facility in San Diego,” the company plans to initiate end-of-phase 2 discussions with the FDA in order to progress LL-BMT1 to phase 3.
Significance?
LL-BMT1 and other drug-eluting contact lenses have the potential to become an alternative therapeutic option for MediPrint Ophthalmics’ intended indications.