The trial assessed TTHX1114 to protect endothelial cells from damage due to cataract surgery in FECD patients. Credit: Alexas_Fotos from Pixabay.

Trefoil Therapeutics has reported additional results from the Phase ll STORM trial of TTHX1114  to protect endothelial cells from damage due to cataract surgery in Fuchs endothelial corneal dystrophy (FECD) patients receiving Descemet Stripping Only (DSO).

The results showed that TTHX1114 activated a dose-dependent response in corneal oedema resolution and improved best corrected visual acuity (BCVA) after surgery in all the patients.

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The percentage of patients with complete resolution of corneal oedema in the high-dose groups at 28 days post-surgery was similar to patients with DSO in comparison with those with DSO and cataract surgery.

Furthermore, at 28 days following surgery, the percentage of patients who recovered from adequate BCVA was also similar between these patient groups, showing 58% of the DSO only patients as against 61% of the DSO and cataract surgery patients.

Trefoil Therapeutics president and CEO David Eveleth said: “Corneal endothelial diseases, like FECD, affect millions of Americans, and today there are limited treatment options.

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“Therefore, it is imperative that we continue to explore new therapies to allow these patients to retain functional vision.

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“It is exciting to see TTHX1114 perform well in controlling post-surgical oedema in at-risk patients undergoing cataract surgery.”

In September 2022, Trefoil announced positive Phase ll study data of TTHX1114, indicating corneal regeneration and vision recovery following DSO surgery.

Meanwhile, in January this year, Trefoil announced the dosing of first subject in the Phase I trial, completing the Phase l epithelial trial in March.

Phase I examined the safety and dosing of topical TTHX1114 to minimise the duration and effect of corneal epithelial defects.