Allotex, Inc. announced the submission of an investigational drug exemption (IDE) to the FDA for its human collagen-based corneal implant—dubbed Allo-1.
Let’s start with this company.
Allotex is an ophthalmic biologics and device company based in the U.S. and Europe.
Its focus involves using tissue addition technology to develop a biological approach for vision correction via its corneal implants, designed to restore vision by “adding”—instead of removing—tissue to the eye.
- To note: The company has so far received regulatory clearance across several countries and regions (launching in Canada just last week)—excluding the United States (so far).
Hold up: Didn’t they just have a major announcement?
Indeed. Earlier this month, the company underwent a leadership change, with co-founder Michael Mrochen, PhD, replacing long-time CEO (and co-founder) David Muller, PhD, as the company progresses in its U.S. and global commercialization efforts.
- Read up on those details here.
Circle back to that ‘tissue addition’ technique.
Also referred to as corneal tissue addition keratoplasty (CTAK), this surgical procedure is considered an alternative to other tissue-removal techniques like LASIK, PRK, and laser-assisted lenticule extraction (LALE).
Importantly: It improves vision and corneal curvature by adding customized tissue (allograft material) to the eye.
- A few notable benefits of this process:
- Suitable for thin corneas
- No corneal tissue is removed from the eye (as is done in corneal transplants)
- Less invasive than a corneal transplant
- Can be customized for each eye
Got it. Now, explain how Allotex’s procedure works.
Known as the TransForm Procedure, this process utilizes the Allotex TransForm lenticule (Allo-1), which comprises a sterile allogeneic corneal tissue designed to alter the shape of the anterior surface of the cornea.
Specifically: This lenticule is a piece of acellular cornea that is sterilized via an electron beam radiation and then shaped using a femtosecond laser.
- Click here for a step-by-step look at how this process works.
And take note: The tissue used is obtained from human corneas via an Eye Bank Association of America (EBAA)-approved eye bank.
So what does the implant look like after laser sculpting?
The implant is flexible enough to allow for any adjustments or removal (if needed).
As for its final shape: It’s approximately 2 to 3.5 mm in diameter and 15 to 25 microns (µm) in central thickness.
Why that specific size: This is intended 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 (Allo-1).”
And which ocular conditions are targeted?
At the moment, Allotex is targeting presbyopia and hyperopia.
“We’ve built a platform that merges the precision of laser-shaped optics with the elegance of natural tissue,” stated Dr. Mrochen. “It’s designed to fit seamlessly into the daily workflows of refractive surgeons.”
Alrighty, I’m up to date. Let’s talk IDE.
What it is: An investigational device exemption is a regulatory submission to the FDA that permits an investigational device (such as Allo-1) to be evaluated in a clinical trial and have safety and effectiveness data collected on it.
- Typically: Such clinical studies are conducted to support a premarket approval (PMA) submission for FDA clearance.
The timeline for this: Once submitted, the FDA has 30 days to review and provide a response to the company (either approval, approval with conditions, or a rejection).
Noted. So, do we know what this proposed clinical trial might look like?
Pending IDE acceptance, the company shared that the study will evaluate the safety and efficacy of Allo-1 in patients with age-related near vision challenges (including presbyopia).
The plan: To launch at multiple investigational sites across the United States.
- No other details have been released so far.
Sounds like it might be a larger study … are there any prior studies conducted on it?
There are!
A 2019 prospective pilot study published in Clinical and Experimental Ophthalmology evaluated the TransForm Procedure and implant for presbyopia correction among 12 adult patients (aged 46 to 57) with a 6-month follow-up.
The general conclusion: Based on preliminary findings, the sterile allograft lenticules (implants) were found to “enhance the visual performance” of presbyopia patients—though long-term data was stressed as a necessary next step to further determine effectiveness and safety.
- See here for specific data numbers.