LENZ Therapeutics' Investigational Drug For Age-Related Blindness Aces Pivotal China Trial, Analyst Says Data Readout May Strengthen Position For Ex-U.S. Partnerships

On Sunday, Corxel Pharmaceuticals and LENZ Therapeutics LENZ released topline data from the Phase 3 JX07001 trial of LNZ100 in patients with presbyopia in China.

Presbyopia is a normal part of aging, making it difficult to see objects up close.

In this China Phase 3 safety and efficacy trial, LNZ100 (1.75% aceclidine HCl) achieved the primary endpoint and key secondary endpoints, with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near and maintaining their optimal distance visual acuity (i.e., not losing five or more letters).

More results showed (all p<0.0001):

• 84% and 69% achieved two-lines and three-lines or greater improvement at 30 minutes, respectively.
• 88% and 74% achieved two-lines and three-lines or greater improvement at 3 hours, respectively, and maintained their optimal distance visual acuity.
• 61% and 30% achieved two-line and three-line or greater improvement at 10 hours, respectively.
• LNZ100 was well-tolerated, and no serious treatment-related adverse events were observed in the trial.

With an Outperform rating, William Blair highlights the impressive consistency in efficacy across studies, similar to what was seen in the CLARITY trials, reinforcing the product’s strong profile.

Notably, the China study was conducted by a separate sponsor in a different region and included participants of a different ethnicity than those in the INSIGHT and CLARITY studies.

While these results aren’t expected to impact Lenz’s ongoing NDA review in the U.S., they increase confidence that the product will likely meet real-world performance expectations if approved by its August 8 PDUFA date.

Last week, the FDA accepted the company’s marketing application seeking approval for LNZ100 for presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million in the U.S.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100.

William Blair highlights that “Moreover, with Lenz yet to sign partnership for other ex-U.S. regions, this positive and consistent readout may incrementally strengthen Lenz’s position in discussions with potential partners for other regions, which could bring in additional sources of nondilutive financing over the coming year.”

Price Action: LENZ stock is up 452% at $28.24 at last check Monday.

Photo by Amanda Dalbjörn on Unsplash

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