Dompé enrolls first patients in phase 3 trial of Isocyclosporin for atopic keratoconjunctivitis

Biopharmaceutical company Dompé has enrolled the first patients in its phase 3 study of Isocyclosporin for the treatment of atopic keratoconjunctivitis (AKC). The multicenter, randomized, double-masked study will compare isocyclosporin against a vehicle control in the improvement of ocular signs and symptoms after 6 weeks of treatment, according to a news release.¹

“This milestone underscores Dompé’s commitment to groundbreaking science with the potential for life-changing patient impact,” said Marcello Allegretti, chief scientific officer at Dompé, in the release. “The dual mechanism of isocyclosporin has the potential to redefine treatment and quality of life for patients living with poorly managed AKC. It also marks an important moment for Dompé as we advance a new asset into late-stage development for a disease with significant unmet need.”

Isocyclosporin is a dual inhibitor of transient receptor potential (TRP) cation channel, mucolipin subfamily, member 2 (TRPML2), and calcineurin, all of which are the key regulators of immune and inflammatory response in chronic inflammatory eye diseases.¹ Currently, there are no FDA-approved treatment options for AKC, with the following therapies leaned on for treatment by eye care providers:

• Topical antihistamines
• Corticosteroids
• Immunomodulators
• Emerging biologics²

“Today, patients with AKC are faced with limited treatment options often intended for short-term use due to severe side effects,” said Ahmed Enayetallah, chief development officer at Dompé, in the release. “The inability to achieve long-term disease control diminishes day-to-day quality of life and exposes patients to potential vision loss from complications like scarring and ulceration. Isocyclosporin is designed to break this cycle by targeting two key disease pathways for more comprehensive long-term control.”

Isocyclosporin was previously evaluated in a pivotal phase 2 study that demonstrated statistically significant improvements in measures of AKC-associated signs and symptoms after 4 weeks of treatment, compared to vehicle control. No discontinuations due to Isocyclosporin-related adverse events were conducted, with no difference in post-installation comfort scores in comparison with vehicle control reported. Dompé stated that a publication detailing the results of the phase 2 study is currently in the works.¹

References

1. Dompé doses first patients in Europe and US in phase 3 study of Isocyclosporin for atopic keratoconjunctivitis. News release. Businesswire. December 16, 2025. Accessed December 16, 2025. https://www.businesswire.com/news/home/20251215885369/en/Domp-Doses-First-Patients-in-Europe-and-US-in-Phase-3-Study-of-Isocyclosporin-for-Atopic-Keratoconjunctivitis

2. Chen JJ, Applebaum DS, Sun GS, Pflugfelder SC. Atopic keratoconjunctivitis: A review. J Am Acad Dermatol. 2014;70(3):569-575. doi:10.1016/j.jaad.2013.10.036