Johnson & Johnson announced it will be co-leading Series A funding of a new refractive surgery-focused start-up company: TECLens.
No intro needed on J&J… let’s get a rundown on TECLens.
Founded in 2013, the New York City, New York-based private medical device manufacturing company is headed up by three ophthalmic device industry vets and a Medical Advisory Board (MAB) of ophthalmic key opinion leader (KOL) experts.
Its focus: Developing corneal cross-linking (CXL) technology to potentially address keratoconus, progressive pediatric myopia, and elective vision correction procedures.
Before we get to this tech, who are these ophthalmic experts?
Led by CEO Tom Dunlap, former executive at various healthcare companies—such as HOYA Surgical Optics, Centricity Vision, Allergan Medical Optics, and Bausch + Lomb—as well as Executive Chairman David E. Acker, Sc.D., and Chief Operating Officer Patrick Lopath, the TECLens’ MAB comprises five notable eyecare professionals:
- Roy S. Chuck, MD, PhD
- Eric D. Donnenfeld, MD
- Deborah S. Jacobs, MD
- Paul Karpecki, OD
- Peter J. McDonnell, MD
Alrighty, now let’s talk tech.
The company’s proprietary technology is dubbed the Quantitative Corneal Cross-linking (qCXL), developed with the intent to reshape the cornea for the following corrections:
- Reading distance vision among presbyopes
- Progressive pediatric myopia control
- Adult refractive errors (ie: hyperopia, low-order myopia)
Explain how it works.
The qCXL technology consists of a device (CXLens) that is applied directly to the eye’s scleral surface following a topical administration of riboflavin (Vitamin B2) ophthalmic solution.
What it does: The device releases patterned ultraviolet (UV) light to “crosslink” (illuminate) specific, selected zones of the cornea.
- This illumination continues until an on-board sensor and algorithms deem that “certain biomechanical properties of the corneal stroma have been adjusted to pre-planned values,” according to TECLens.
What biomechanical properties are measured?
These real-time parameters include:
- Increase in corneal stiffness
- Collagen fiber tightening
- Corneal thickness changes
Gotcha. And this enables…?
Such “closed-loop dosing” results in precise control over corneal shape—with the capability to “predictably improve a patient’s vision.”
- Refresh: Closed-loop dosing involves selective stiffening of the corneal surface
And what other features does it include?
The scleral lens platform also provides:
- Integrated real-time ultrasound elastography
- Proprietary riboflavin-driver tech for intact corneal epithelium procedures
- Possibility for bilateral treatment
Click here for a visual of the procedure.
So how long does the entire process take?
The treatment is estimated to take less than 30 minutes.
How are patients taken into consideration during the procedure?
The company noted that, as a non-invasive, transepithelial approach, the CXLens scleral design was developed to be both comfortable for the patient and stable on the eye.
- In fact: Patients can be treated with either their eyes opened or closed, sitting upright in a chair or lying down.
- Note: No lid speculum is required.
Why should clinicians consider this for their practice?
The company has noted that the qCXL offers a “technologically-advanced (CXL) platform” without needing to skimp on operational simplicity (it has a small clinical footprint) or affordability.
Along the lines of affordability, it’s also reported to be designed as an “inexpensive” control system that offers an easy market entry access for clinicians to both qCXL and refractive correction.
- As a bonus: The system can simultaneously treat multiple eyes and patients—with no assistant required.
And what’s the overall significance of this?
This technology could potentially offer relief for a wider range of patients—including those who may not be the best candidates for other refractive procedures, or those interested in alternative treatments to standard refractive surgeries.
Plus, Johnson & Johnson noted that the treatment may even (in the future) support cataract patients who are candidates for presbyopia-correcting intraocular lenses (PC-IOLs).
This sounds promising… has the system undergone any clinical research yet?
Yes, in fact. TECLens noted it successfully conducted a pilot study that evaluated the system’s capabilities for providing qCXL treatment in nine corneal transplant candidates with advanced keratoconus.
What was measured: Maximum keratometry, thinnest corneal thickness, and endothelial cell density between screening and 6 months after qCXL.
Plus: Differences in best-corrected visual acuity (BCA) between screening and 6 months post-qCXL
And the findings?
Published in Translational Vision Science & Technology in April 2021, the results included:At 6 months after the novel CXL procedure, the treatment eyes had:
- Average −1.0 ± 1.6 diopters decrease in the maximum keratometry (P = 0.049)
- Nonsignificant 2.3 ± 7.5 letter improvement in BCVA (P = 0.19)
- Nonsignificant −17 ± 14 µm decrease in thinnest corneal thickness (P < 0.01)
- Nonsignificant −86 ± 266 cells/mm2 decrease in endothelial cell density (P = 0.20)
The study authors concluded that the CXLens demonstrated feasibility in its treatment for keratoconus and was deemed ready for large-scale studies with longer follow-up periods.
With that in mind, any upcoming studies to know about?
Yes! TECLens reported it is currently in the planning stages of its first refractive-correction clinical studies for the CXLens device. So you know what that means…
Stay tuned!