Marinomed Biotech AG (VSE:MARI), an Austrian science-based biotech company with globally marketed therapeutics derived from innovative proprietary technology platforms, announced today the topline results for its Phase II clinical trial of Tacrosolv eye drops to treat ocular hay fever symptoms. The placebo-controlled Phase II clinical trial was conducted at the Vienna Challenge Chamber (Austria) to assess safety and efficacy of two different dose of Tacrosolv in a crossover design. The applied doses contained only 2.5 % and 5 % of the dose used in Tacrolimus eyedrops that are marketed in Japan for the treatment of vernal conjunctivitis. After one week of treatment, the higher dose resulted in a statistically significant reduction of ocular symptoms in the time period starting 3.5 hours after the challenge (p < 0.05). A comparison of the ocular symptoms on day 1 with day 8 showed a significant reduction of symptoms in the case of Tacrosolv treatment [LMH1] (p < 0.01) without any effect of the placebo treatment. Additionally, nasal symptoms were assessed and showed a significant reduction at day 8 (between 0 to 4 hours after the challenge, p < 0.05). These results indicate the high potential of tacrolimus being an effective treatment of ocular inflammation exemplified by allergic conjunctivitis and other allergic manifestations.
“The higher dose showed significant relief of allergic symptoms in the eyes and also in the nose. The latter is surprising and supports the effectiveness of Tacrolimus also in allergic rhinitis. This topline data strongly supports our hypothesis that a fully solubilized Tacrolimus can be developed as an effective therapy for ocular inflammation including dry eye disease and rhinoconjunctivitis,” commented Dr. Eva Prieschl-Grassauer, Chief Scientific Officer of Marinomed.
The study was conducted as a randomized, placebo-controlled, crossover, double-blind, single site Phase II clinical trial. Patients received Tacrosolv eye drops (50 µg / ml eye drop) in either a high (two drops per day) or low dose (one drop per day) compared to placebo (3 % propylene glycol in saline) in two treatment cycles. In the first treatment cycle, patients were administered Tacrosolv or placebo for 8 days. This was followed by a washout period of at least 13 days. In the second treatment cycle, treatment was switched to placebo or Tacrosolv eye drops, respectively.