𝐏𝐫𝐞𝐜𝐢𝐬𝐢𝐨𝐧-𝐌𝐨𝐥𝐝𝐞𝐝 𝐓𝐎𝐏𝐀𝐒® 𝐂𝐎𝐂 𝐂𝐨𝐦𝐩𝐨𝐧𝐞𝐧𝐭𝐬 𝐄𝐧𝐚𝐛𝐥𝐞 𝐋𝐨𝐧𝐠-𝐓𝐞𝐫𝐦 𝐓𝐢𝐬𝐬𝐮𝐞 𝐏𝐫𝐞𝐬𝐞𝐫𝐯𝐚𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 𝐒𝐲𝐬𝐭𝐞𝐦 𝐑𝐞𝐥𝐢𝐚𝐛𝐢𝐥𝐢𝐭𝐲 𝐟𝐨𝐫 𝐂𝐨𝐫𝐧𝐞𝐚𝐥 𝐀𝐥𝐥𝐨𝐠𝐫𝐚𝐟𝐭𝐬

Allotex Inc., an ophthalmic biologics and medical device company pioneering Tissue Addition Technology – a new category of vision correction designed to restore vision using natural human tissue – is partnering with Daicel High Performance Polymers (HPP) and its TOPAS Advanced Polymers business to advance next-generation corneal allograft technologies.

This collaboration brings together Allotex’s expertise in human tissue-based implants with Daicel HPP’s advanced material science capabilities to develop a high-performance storage and delivery system designed to preserve tissue integrity, ensure product reliability, and support consistent outcomes in clinical use.

Allotex’s proprietary approach is based on using precisely shaped human corneal tissue to preserve the eye’s natural structure through a tissue-addition method that is both biocompatible and reversible.

Allotex’s lead product, the Allotex TransForm™ Allogenic Corneal Inlay, is a thin, laser-shaped disc of sterile corneal tissue designed to be implanted beneath a femtolaser flap, where it integrates seamlessly with the patient’s cornea. By adding tissue rather than removing or permanently altering it, the inlay represents a minimally invasive alternative to more disruptive procedures.

This approach is particularly well suited for specific patient profiles – including those at earlier stages of lens dysfunction with otherwise healthy ocular anatomy – who are seeking functional improvement while remaining cautious about procedures that permanently alter tissue or involve intraocular intervention.

COC-Based System Enables Long-Term Tissue Integrity

A critical element of Allotex’s technology platform is its corneal lens storage and delivery system, which incorporates precision molded components manufactured from TOPAS® cyclic olefin copolymer (COC). Allotex selected TOPAS® COC after evaluating multiple polymer options for its storage system. The biological corneal inlays must be maintained in a moist environment for up to 12 months, requiring material that can reliably preserve internal chamber conditions over extended shelf life.

TOPAS COC was selected due to several critical performance characteristics:

Exceptional material purity, supporting biologic compatibility

High chemical resistance, ensuring stability with storage media

Excellent moisture barrier properties, minimizing solvent loss over time

Optical transparency, compatible with E-beam sterilization processes

Many competing polymers permit gradual moisture transmission, leading to solvent loss, drying, and compromised tissue viability. In contrast, the low moisture permeability of COC helps maintain chamber humidity and preserve the structural and functional integrity of the corneal allograft throughout long-term storage.

“This collaboration reflects a shared commitment to advancing a more biologically aligned approach,” said Evan Sherr, COO, Allotex. “By combining our tissue-based platform with advanced material capabilities, we are building a system that supports both the integrity of the implant and the needs of the clinicians who use it.

“At Daicel High Performance Polymers, we see the greatest impact when material science helps solve complex challenges at the system level,” said Raghavendra “Raj” Maddikeri, Business Development Manager – Healthcare, Daicel High Performance Polymers. “Our collaboration with Allotex demonstrates how the right material can help preserve sensitive biologic components while supporting performance, quality, and scalability.

Clinical Development and Regulatory Status

Allotex operates in both the U.S. and Europe. The company’s biologic corneal implant technologies are approved for use in the European Union and are currently undergoing clinical development in the U.S. Allotex has submitted FDA Investigational Device Exemption (IDE) application to support clinical trials of its corneal implant platforms.

Presbyopia, a condition that gradually reduces the eye’s ability to focus on nearby objects, alone affects more than 1.8 billion people worldwide, with prevalence expected to increase as populations age. Allotex’s platform addresses this growing need through a reversible, tissue preserving solution enabled by biologic materials and precision engineered delivery systems.

The collaboration between Allotex and Daicel HPP underscores a shared commitment to advancing ophthalmic innovation through the integration of biologic design, material science, and precision manufacturing — ultimately delivering meaningful value for both patients and eye care providers.

source : Topas