VIZZ Advances in Asian Markets: LENZ Therapeutics and Lotus Pharma Push Regulatory Milestones in South Korea

LENZ Therapeutics Inc. continues expanding its presbyopia treatment footprint as partner Lotus Pharmaceutical Co., Ltd. moves toward market approval in South Korea. The collaboration, formalized through a May 2025 commercialization agreement covering the Republic of Korea and select Southeast Asian nations—including Thailand, Philippines, Vietnam, Malaysia, Brunei, Indonesia, and Singapore—has now entered a critical regulatory phase with the filing of a New Drug Application (NDA) to South Korea’s Ministry of Food and Drug Safety.

The Drug Profile and Clinical Foundation

VIZZ represents a novel approach to presbyopia management, delivered as a preservative-free, single-use eye drop administered once daily. The formulation harnesses aceclidine, a pupil-selective miotic agent that works by temporarily narrowing the pupil to enhance depth of focus for presbyopic patients. This mechanism addresses the age-related deterioration in near vision that characterizes presbyopia, enabling patients to refocus on close-distance tasks that become increasingly difficult with age.

The regulatory submission in South Korea draws validation from three randomized, double-masked Phase 3 studies termed the CLARITY trials, conducted across U.S. sites. Data from these trials demonstrated that VIZZ met all primary and secondary efficacy endpoints for near vision enhancement, with the drug reaching therapeutic effect within 30 minutes and sustaining benefit for up to 10 hours per application.

Financial Terms and Market Positioning

The partnership structure reflects substantial confidence in VIZZ’s commercial potential. LENZ stands to receive milestone payments totaling up to $125 million—comprising upfront fees, regulatory clearance bonuses, and commercial achievement thresholds—alongside double-digit tiered royalties on net sales in these territories. This financial arrangement underscores the projected value of capturing presbyopia treatment demand across a significant Asian patient population.

The South Korea NDA represents the first official regulatory filing stemming from this exclusive licensing and commercialization agreement, signaling the partnership’s commitment to methodical market entry. VIZZ has already secured U.S. market approval for presbyopia in adults as of July, establishing clinical credibility heading into international submissions.

Market Context

Presbyopia affects a substantial demographic, particularly as global populations age. The condition stems from gradual stiffening of the eye’s crystalline lens, rendering near vision progressively blurry. With an aging population across East Asia and Southeast Asia, regulatory approvals in these markets address significant unmet patient need and represent meaningful commercial opportunities for both LENZ and Lotus Pharma.

At Monday’s close, LENZ shares traded at $30.40, reflecting recent trading patterns in the biotech sector.