Eye drops to treat presbyopia meet efficacy endpoints in phase 3 trials
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An investigational presbyopia treatment met primary efficacy endpoints in two phase 3 clinical trials, reaching statistical significance in near vision improvement, according to a press release.
AGN-190584 ophthalmic solution (pilocarpine 1.25%, Allergan) demonstrated positive topline results in the GEMINI 1 and 2 clinical trials, in which 750 patients were randomly assigned in a one-to-one ratio to receive AGN-190584 or placebo bilaterally once daily for 30 days.
In GEMINI 1, a significantly greater proportion of participants treated with AGN-190584 than vehicle gained three lines or more in mesopic, high contrast, binocular distance corrected near visual acuity at 30 days. In GEMINI 2, statistically significantly more patients treated with AGN-190584 than vehicle gained three lines or more in mesopic, high contrast, binocular distance corrected near visual acuity without loss of more than five letters in corrected distance visual acuity at 30 days.
The trials met most secondary endpoints as well, including increases in vision-related reading ability and reductions in the impact of presbyopia on daily life.
No treatment-emergent serious adverse events were observed. The most common non-serious adverse events, occurring in 3% or more of participants treated with AGN-190584, included headache, conjunctival hyperemia, blurred vision and eye pain, the release said.
Data from the studies will form the basis of a new drug application submission to the FDA in the first half of 2021.
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