Mitotech begins phase 3 dry eye trial
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Mitotech S.A. has begun enrollment in VISTA-2, a phase 3 clinical trial of SkQ1, a dry eye disease treatment candidate, according to a press release.
SkQ1, a cardiolipin peroxidation inhibitor, addresses dry eye by acting on the mitochondria at a cellular level, the release said.
The phase 3 trial builds on positive results from the VISTA-1 multicenter, randomized, double-masked, placebo-controlled study, in which SkQ1 demonstrated broad action in the intent to treat group, even though primary endpoints of that trial were not met.
In VISTA-1, SkQ1 showed statistically significant reduction of ocular discomfort as early as after 4 weeks of treatment and conjunctival fluorescein staining showed statistically significant improvement vs. vehicle.
“VISTA-1 results revealed early onset of action of SkQ1 for a spectrum of clinically relevant symptoms and signs such as ocular discomfort and fluorescein staining. Combined with excellent drug tolerability profile this positions SkQ1 as an important potential treatment option for dry eye disease patients worldwide,” said Natalia Perekhvatova, CEO of Mitotech S.A.
VISTA-2 is similar in design to VISTA-1 but will include twice as many patients.