Key Takeaways
- Tarsus acquired iRenix Medical and IRX-101, an investigational ocular antiseptic for patients receiving intravitreal therapy.
- In the phase 2b/3 RELIEF trial, IRX-101 reduced postprocedural pain scores by approximately 50% and corneal fluorescein staining by approximately 25% versus povidone-iodine.
- Tarsus plans to begin a phase 3 study of IRX-101 in the first half of 2027, with results expected in 2028.
Tarsus has acquired iRenix Medical and its investigational ocular antiseptic IRX-101, a stable aqueous chlorine dioxide solution being developed to reduce postprocedural pain and corneal toxicity in patients receiving intravitreal therapy.
In a completed phase 2b/3 RELIEF trial of 154 patients, IRX-101 demonstrated statistically significant improvements versus povidone-iodine on two coprimary endpoints, according to Tarsus. Postprocedural pain scores were reduced by approximately 50% relative to povidone-iodine (P = .0003), and half of patients in the IRX-101 group reported a pain score of zero. Corneal fluorescein staining, a measure of corneal surface damage, was reduced by approximately 25% relative to povidone-iodine (P = .0003).
Tarsus said it plans to initiate a phase 3 study in the first half of 2027, following FDA feedback, to evaluate the tolerability and safety of IRX-101 compared with povidone-iodine. Results are expected in 2028.
More than 11 million intravitreal injections are performed annually in the United States, most using povidone-iodine as the preprocedural antiseptic, according to the company. Tarsus stated that discomfort and corneal toxicity associated with povidone-iodine exposure may be a recurring burden for patients with chronic retinal diseases who require repeated injections.
The transaction included approximately $75 million in upfront consideration, split evenly between cash and Tarsus common stock, with potential approval and commercial milestone payments of up to $490 million.
