Jixing Pharma Inks Exclusive Deal for LNZ100, a Novel Presbyopia Treatment with NDA Accepted by FDA

Oct 22, 2024 15:17 CST Updated 15:17

CORXEL

Developer of Oral Small Molecule Cardiac Myosin Inhibitors

LENZ Therapeutics

Ophthalmic Drug Product Developer

On October 22, CORXEL's partner LENZ Therapeutics announced that the FDA had accepted the company'sTreatment of PresbyopiaLNZ100 New Drug Application（NDA）。

Screenshot source: Official WeChat account of the company

It is estimated that 1.8 billion people globally suffer from presbyopia, including 128 million in the United States. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date for LNZ100.（PDUFA）Target Action Date Set forAugust 8, 2025The FDA stated that it does not intend to hold an advisory committee meeting to discuss the application.

This timeNDA Submission is Based onKeyIII Positive Data Results from CLARIFY Clinical Study

InIII Phase Safety and Efficacy Trial(CLARITY 1 and 2)In China, LNZ100 (1.75% aceclidine) achieved the primary endpoint and key secondary endpoints,Best Corrected Near Vision(BCDVA)Significantly improved by three lines or more, while the distant vision did not decrease by one line or more.In CLARITY 2, clinical results showed rapid and sustained improvement in patients' vision:

Rapid onset: 71% of patients experienced ≥3 lines of vision improvement within 30 minutes。

Reached Primary Endpoint: 71% of Patients Within 3 HoursVisual acuity improvement ≥3 lines。

Long duration: 40% of patientsVision improvement ≥3 lines can be sustained10 Hours。

Near vision improvement in CLARITY 1 and 2 was repeatable and consistent over the four-week study period.

April 14, 2022CORXEL Obtains Commercialization Rights for LENZ Therapeutics' Two Presbyopia Drugs, LNZ100 and LNZ101, in Greater China (Including Mainland China, Hong Kong, Macao, and Taiwan).

According to the Insight database, this drug is currently in Phase III clinical trials in China.（CTR20232913）。

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