LENZ submits UK application for VIZZ presbyopia treatment

LENZ Therapeutics submitted a UK marketing authorization application for VIZZ for presbyopia on April 20, 2026. The filing follows FDA approval in July 2025 and EMA validation in March 2026.

LENZ Therapeutics said it has submitted a Marketing Authorization Application to the United Kingdom’s Medicines and Healthcare products Regulatory Agency for the review and approval of VIZZ (aceclidine ophthalmic solution) for the treatment of presbyopia in adults. The company said the submission was made on April 20, 2026 and follows FDA approval in July 2025 and EMA validation of the VIZZ MAA in March 2026.

The company said the MHRA filing marks the sixth ex-U.S. regulatory submission for VIZZ and follows its recent MAA submission to the European Medicines Agency. VIZZ is described as a once-daily treatment for age-related blurry near vision.

The filing is supported by three Phase 3 CLARITY trials that met all primary and secondary endpoints. The company said VIZZ improved near vision within 30 minutes, lasting up to 10 hours, and showed no serious treatment-related adverse events in more than 30,000 treatment days.

The company said the submission is part of efforts to position VIZZ for broad international expansion as it advances the early product launch in the United States.

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References

  1. LENZ submits UK VIZZ application for presbyopia - Stock Titan · stocktitan.net
  2. LENZ Therapeutics seeks EMA nod for VIZZ presbyopia drop - Stock Titan · stocktitan.net
  3. South Korea's Presbyopia Market Braces for YUVEZZI, VIZZ Showdown · chosun.com