US pharmaceutical company LENZ Therapeutics Inc (Nasdaq:LENZ) announced on Monday that it has submitted a marketing authorisation application (MAA) to the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) for VIZZ (aceclidine ophthalmic solution) 1.44%, a treatment for presbyopia in adults.
This submission follows validation of the VIZZ MAA by the European Medicines Agency in March 2026 and represents the sixth ex-US regulatory filing for VIZZ, supporting the company's international expansion strategy.
VIZZ is described as the first and only aceclidine-based eye drop for presbyopia. It received US Food and Drug Administration approval in July 2025, with LENZ continuing to pursue global commercialisation.
The regulatory filing is supported by Phase 3 CLARITY trial data demonstrating improvements in near vision within 30 minutes lasting up to 10 hours, with no serious treatment-related adverse events reported across more than 30,000 treatment days.
LENZ said the UK submission is a key step toward broader commercialisation in Europe and expanding access to patients affected by age-related loss of near vision.
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