Tetratherix has reported early animal results for a cataract surgery gel that it says can be left in the eye without triggering the pressure spike, the most common early complication of the procedure.
The ASX-listed company told the market that it had completed a first preclinical performance study of Optimatrix, an ophthalmic viscosurgical device made from its Tetramatrix polymer.
In the study, none of the gel was washed out. Tetratherix said pressure in the treated eyes returned to pre-operative levels within six hours and had not risen again at 48 hours.
Viscosurgical devices are used in almost every cataract operation to hold the front chamber of the eye open while the clouded lens is removed and replaced. Every product on the market must be actively washed and suctioned out, because residual material can inflame the chamber and block the eye's drainage filter.
Animals in the study were operated on in both eyes on the same day by the same surgeon, with Optimatrix left in full in one eye and a sham balanced salt procedure removed as normal in the other, so each animal served as its own control. Tetratherix said the Optimatrix eyes sat 6.5 mmHg below the sham eyes at both six and 24 hours.
The company said the gel is a liquid in the syringe, sets on body heat, and returns to a liquid when irrigated with cooled saline. It said surgeons should not leave the product in place and that the retention test was designed to show that residual gel is tolerated.
Founder and chief technology officer Dr Ali Fathi said the study addressed a routine surgical risk.
"Our results show that with Optimatrix the eye settled back to where it started inside a day with zero product removed, reinforcing the safety profile of the entire Tetramatrix platform."
The results are preclinical and in a small animal model, with no human data and no published peer review. The formal preclinical study, which will remove the gel at the end of the operation and compare it against the standard of care over 90 days for safety and local tissue response, has only just begun. Tetratherix said it has engaged the United States Food and Drug Administration through a pre-submission process to confirm the product code and required studies, a step well short of clearing any approval pathway.
Tetratherix also said Optimatrix is fully synthetic, unlike marketed devices built on sodium hyaluronate, chondroitin sulfate or hydroxypropyl methylcellulose, and that two patents covering composition and use are in the PCT phase.
The company puts the addressable market at about US$3 billion across more than 20 million cataract operations a year. It does not intend to commercialise the product itself, saying a partner would own regulatory approval, reimbursement and market planning.
