SCIENTIFIC ASPECTS AND CLINICAL RESULTS

By inhibiting RASP, which are elevated in a variety of inflammatory diseases, reproxalap represents a novel mechanism for diminishing ocular inflammation in allergic conjunctivitis. In clinical trials, reproxalap has consistently demonstrated statistically significant and clinically relevant activity. [12].

Figure : Mechanism of Reproxalap [12].

As we have known, most immunological drugs shut down specific molecules, obstructing the immune system, and leading to toxicity. In contrast, modulation of the immune system maintains immune function, but allows for a lower level of inflammation. Therefore, Reproxalap is a novel approach for immune system regulation.

Empiric results for Reproxalap success are documented by scientific publications and clinical trials. In the latest US Phase 3 trial, the product showed clearly favorable outcomes when compared to the recent standard of care.

Although a 2017 phase IIb trial reproxalap failed to meet the primary endpoint of showing a one-point improvement over placebo on a scale of eye itching, which make some might see designing the Alleviate phase III trial along similar lines to the phase IIb as a risky move, the company claims a victory on a key secondary endpoint, the two-point responder rate. The primary endpoint achieved is a significant reduction in ocular itching with reproxalap, as assessed by area under the ocular itch score curve from 10 to 60 minutes after allergen challenge