Marinomed Biotech Reports Promising Phase 2 Results for Tacrosolv Eye Drops in Treating Allergic Rhinoconjunctivitis

Marinomed Biotech has announced clinical data from its phase 2 dose-finding clinical trial on Tacrosolv, a novel eye drop formulation for treating allergic rhinoconjunctivitis. The results, now published in the peer-reviewed journal Clinical Ophthalmology, indicate that Tacrosolv, formulated using the company’s proprietary Marinosolv technology, significantly reduces both ocular and nasal symptoms associated with allergic conjunctivitis. The trial results are particularly noteworthy given the ultra-low dose of Tacrolimus used in the treatment, according to Marinomed. 

The placebo-controlled trial evaluated two doses of Tacrosolv in patients who suffer from allergic rhinoconjunctivitis. The higher dose, containing just 0.005% Tacrolimus, was found to significantly alleviate symptoms of allergic conjunctivitis. It also showed effectiveness in reducing nasal symptoms typically associated with allergic reactions, such as itching and sneezing. This success was achieved with a concentration of Tacrolimus 20 times lower than the only other Tacrolimus-based eye drop currently available on the market, which is sold exclusively in Asia, Marinomed stated in a company news release.

“Tacrolimus is an immunosuppressive agent commonly used for organ transplant patients or to treat inflammatory skin and eye conditions. However, existing formulations, like the one marketed in Asia, are suspensions with very low water solubility, leading to poor bioavailability in inflamed tissue. This limits their efficacy, and it can take days or weeks to achieve results," said Eva Prieschl-Grassauer, Chief Scientific Officer of Marinomed. "Our Marinosolv technology has overcome this hurdle by improving the solubility of Tacrolimus in a water-based formulation, significantly increasing its bioavailability. This allows for lower doses and a faster onset of action.”

In the study, participants with a history of allergic conjunctivitis were randomized to receive either Tacrosolv or a placebo over an 8-day period. Controlled allergen exposure was used to trigger symptoms on days 1 and 8. Participants recorded their allergy symptoms throughout, focusing on ocular, nasal, and respiratory symptoms. The trial’s primary endpoint was the Total Ocular Symptom Score (TOSS) on day 8, with additional evaluations of safety and effectiveness.

Results showed that on day 8, Tacrosolv reduced ocular symptoms, such as redness and watery eyes, more effectively than the placebo. Unexpectedly, nasal symptoms—typically harder to treat with eye drops—also showed significant improvement, with some relief appearing after just one application.