Ophthalmic biologics and device company Allotex Inc. announced a shift in executive leadership this month to support the continued commercialization plans for its allogeneic corneal tissue technology.
First, tell me about Allotex.
The startup was co-founded in 2014 by Michael Mrochen, PhD, and David Muller, PhD, founder of two other startups:
- Summit Technologies, Inc. → Recipient of one of the first FDA approvals for using excimer laser in LASIK procedure for nearsightedness and astigmatism
- Avedro, Inc. → Acquired by Glaukos Corporation in 2019; Original developer of the KXL System, the first and only FDA-approved proprietary corneal remodeling platform involving corneal crosslinking (CXL)
To note: Dr. Muller has served as CEO since the company was established.
And its approach?
With office locations in Boston, Massachusetts, and across Europe, Allotex was launched with the intent to develop and advance a natural, biological approach to vision correction.
- What this was based on: Non-allogeneic, synthetic corneal implants that have already received varying marketing approvals across the globe, including in the U.S. and Europe, for refractive purposes.
Specifically: The company is developing novel therapeutic solutions that use “precisely-shaped” human corneal allografts to create a biocompatible inlay—essentially: a permanent, living contact lens or lens insert—that integrates with the eye's natural structure.
- Its target patients: Those diagnosed with presbyopia and hyperopia.
Talk more about this solution.
The name: Allotex TransForm Lenticule.
- What it is: A piece of acellular cornea sterilized with electron beam radiation and formed to a specific shape via a femtosecond laser.
The details: This biocompatible lenticule (which is stored at room temperature) is made of sterile allogeneic corneal tissue that alters the shape of the cornea’s anterior surface—moving the point of focus to the retina.
- A note about this sterilization: Allotex uses the nonprofit ocular tissue agency VisionGift to acquire, clean, sterilize, and ship corneas to the company.
And how does the clinical process work, exactly?
The step-by-step process entails:
- The TransForm lenticule is first placed directly on top of a patient’s stroma (exposed via a laser-created corneal flap)
- Once positioned, the corneal flap is closed and the lenticule can be smoothed over for a more normal appearance.
See a visual breakdown of how this is performed—and watch a video here.
And that’s it?
That’s it. The entire outpatient procedure takes around 10 minutes.
Once sculpted by the laser, the final shape is roughly 2 to 3.5 mm in diameter with a central thickness of 15 to 25 microns (µm).
The expectation: Allotex noted that this new diameter size is designed to give a patient “improved near and intermediate vision” as well as enable them to “retain distance vision from the rays entering the pupil around the periphery of the TransForm lenticule.”
- Plus: The implant itself is flexible, enabling adjustments or removal, if needed.
Is it still under clinical investigation?
In the United States—yes.
But outside the country: Allotex has already received market clearance and is currently “executing a controlled market launch” of the TransForm procedure to the following regions:
- Australia
- Canada
- Europe
- The Netherlands (just this month)
- Turkey
So what’s the plan for expanding into the U.S.?
That’s where the company’s new CEO comes in: Co-Founder Michael Mrochen, PhD.
Take note: Since Allotex’s launch 11 years ago, the 30-year industry veteran has largely led the research and development activities as well as clinical trials of the company’s technology.
- And outside of Allotex: Dr. Mrochen has founded, led, and worked with companies specializing in the development and commercialization of multiple ophthalmic technologies and procedures.
What will his new role entail?
With experience on the scientific and commercial side of ophthalmic technology development, Dr. Mrochen will reportedly lead the company’s regulatory efforts to pursue commercialization of Allotex’s technology in the United States.
Importantly: Dr. Muller is said to be supporting this transition—”Michael is the right person to lead Allotex into its next chapter,” he was quoted—and will continue with the company as scientific advisor.
Now talk about these commercialization plans.
In the U.S., the company shared that regulatory efforts are progressing—with a goal to submit an investigational device exemption (IDE) sometime before the end of Q2 2025.
- Refresh: An IDE enables an investigational device to be used in a U.S. clinical study so safety and effectiveness data can be collected.
And take note: Q2 ends next month (June 30).
That said—stay tuned for developments on this!