LENZ submits UK marketing application for presbyopia treatment
LENZ Therapeutics Inc. (NASDAQ: LENZ) submitted a Marketing Authorization Application to the United Kingdom's Medicines and Healthcare products Regulatory Agency for VIZZ, an eye drop treatment for presbyopia in adults.
The submission represents the sixth regulatory filing outside the United States for VIZZ (aceclidine ophthalmic solution) 1.44% since the company received FDA approval in July 2025. LENZ previously submitted a Marketing Authorization Application to the European Medicines Agency in March 2026.
VIZZ is designed as a once-daily eye drop that provides near vision improvement for up to 10 hours. The drug uses aceclidine as its active ingredient and works by causing contraction of the iris sphincter muscle, creating a pinhole effect that extends depth of focus.
The application is supported by data from three Phase 3 clinical trials called CLARITY studies conducted in the United States. In these randomized, double-masked, controlled studies, VIZZ met all primary and secondary endpoints, demonstrating the ability to improve near vision within 30 minutes. The treatment was tested across over 30,000 treatment days with no serious treatment-related adverse events observed.
Common reported side effects included instillation site irritation affecting 20% of participants, dim vision in 16%, and headache in 13% of those studied. Most adverse reactions were described as mild, temporary, and self-resolving.
Presbyopia affects the ability to see objects clearly at close range and typically begins impacting people over age 45. The condition results from the gradual hardening of the eye's crystalline lens, which reduces its ability to change shape and focus on near objects.
LENZ Therapeutics is headquartered in San Diego, California, and focuses on commercializing VIZZ for presbyopia treatment. The company states that presbyopia affects approximately 1.8 billion people globally and 128 million people in the United States.
