MediPrint Ophthalmics released new findings from its phase 2b clinical trial regarding its lead asset: LL-BMT1, a proprietary and drug-eluting contact lens (CL) under clinical investigation for managing mild-to-moderate glaucoma.
The results were presented earlier this month during the 2024 annual meeting of the American Academy of Optometry (AAO) in Indianapolis, Indiana, by Ian Ben Gaddie, OD, of the Gaddie Eye Centers in Kentucky.
Quick refresher on MediPrint.
The San Diego, California-based MediPrint clinical-stage eyecare pharmaceutical company is working to develop and commercialize a proprietary and non-invasive ocular drug delivery portfolio.
Its target ocular conditions:
- Glaucoma
- Dry eye
- Post-cataract
- Ocular comfort enhancement
- Ocular allergy
And what kind of science is its portfolio based on?
The name: MediPrint process.
- What it is: A proprietary printing technology and ink that are consolidated into a drug delivery platform designed to deliver a sustained, continuous release of FDA-approved ophthalmic drugs via FDA-approved CLs to treat ocular diseases
- Take a closer look at what this five-step process entails.
The intended result: A novel mechanism for treating ocular diseases and conditions via a “non-invasive, cost-effective treatment,” according to the company.
Interesting … now explain LL-BMT1.
This weekly medicated, 3D-printed, preservative-free, extended-wear CL is designed to release bimatoprost—printed directly on an ocufilcon D soft hydrophilic CL—via MediPrint’s proprietary inkjet printer.
In other words: The lens delivers therapeutics directly to the eye in lieu of via traditional topical application (i.e., eye drops).
And its clinical journey thus far?
LL-BMT1 is under clinical investigation in the Sustained Innovative Glaucoma and ocular Hypertension Treatment (SIGHT) clinical program.
Included in this program:
- SIGHT-1 study (NCT04747808)
- SIGHT-2 study (NTC not available)
- Phase 2b, group 1 (low-dose) findings reported in June 2023
- Study completed in March 2024
- Phase 2b, group 1 (low-dose) findings reported in June 2023
And this new data is based on …
The SIGHT-2 study, which was designed as the following
- Participants: (n = 28) Diagnosed with open-angle glaucoma (OAG)
- Setup: Two groups:
- Group 1: Treated with LL-BMT1
- Group 2 (control): Treated with bimatoprost 0.01% ophthalmic solution
- Evaluation period: 3 weeks
Now these findings.
Per MediPrint, the study “demonstrated that the 32-µg dose of LL-BMT1 achieved equivalence to the efficacy of bimatoprost 0.01% in reduction of intraocular pressure (IOP).”
Further: LL-BMT1-treated patients (group 1) required only six lens insertions over the 3-week evaluation period.
- This equates to an 86% reduction in treatment frequency (versus standard daily eye drops).
Why this is significant: Lower dosing frequency translates to an increased potential for LL-BMT1 to improve both patient compliance and outcomes for glaucoma management.
How did it perform for ocular comfort and health?
Thanks to its infusion of hyaluronic acid (HA), LL-BMT1 “significantly improved patient-reported comfort and relief from dry eye symptoms.”
The numbers: For participants within the 32-µg dose range, both comfort and dry eye symptoms improved by an estimated 38% and 40%, respectively.
- Why this is significant: Aside from its apparent therapeutic benefits, MediPrint noted that this indicates LL-BMT1 is potentially suitable for weekly and extended wear.
Moving on to safety and tolerability.
The lenses were found to be both “safe and well–tolerated among all participants,” with no serious adverse events (AEs) observed for either group.
What this means: With a less invasive option from laser or surgical procedures, LL-BMT1 is also a notably “less burdensome alternative” to daily eye drops, according to Dr. Gaddie.
This definitely sounds promising … so how does it compare to prior data?
For a brief rundown on LL-BMT1’s performance in the SIGHT-1 study, click here.
- Hint: The CL demonstrated a favorable safety profile with 100% tolerability.
And as for the SIGHT-2 study: See its most recent findings (reported in March 2024).
- One more hint: LL-BMT1 demonstrated a clinically meaningful reduction (5.5 mmHg) in IOP versus a timolol 0.5%(the reference drug), which was maintained throughout the study period.
Nice! So what’s next?
With this latest promising data, MediPrint is turning its focus to kicking off two new clinical programs in 2025:
- The first program: Focused on comfort improvement with HA in the daily disposable lens market
- The second program: Initiation of the phase 3 clinical study for LL-BMT1 for glaucoma
As always, stay tuned for more details!