LENZ Therapeutics, Inc. has submitted a new drug application (NDA) to the FDA for LNZ100 (1.75% aceclidine), its investigational ophthalmic solution intended to treat presbyopia.
First up: this company.
LENZ is a San Diego, California-based, late-stage biopharmaceutical company targeting the development and commercialization of vision-improving therapeutics.
- Note: Earlier this year, the company merged with Graphic Bio, Inc to focus on and advance its lead investigational candidates: LNZ100 and LNZ101 (1.75% aceclidine and brimonidine).
Talk about LNZ100.
LNZ100 is formulated as preservative-free, single-use, once-daily eye drops intended to treat presbyopia.
About its key ingredient: Aceclidine is a small-molecule muscarinic acetylcholine receptor agonist that can cause miosis, potentially resulting in a “pinhole” effect to improve near vision and prevent a myopic shift.
- Note: Prior research has supported the use of aceclidine for the treatment of open-angle glaucoma (OAG); in fact, in Europe, it’s been marketed for this indication for over half a century.
What’s the clinical data on it?
This submission is based on promising findings from the company’s pivotal phase 3 CLARITY program consisting of two 6-week efficacy trials, which evaluated LNZ100 and LNZ101:
- CLARITY 1 (NCT05656027)
- CLARITY 2 safety study (NCT05753189)
The outcome measure: Percentage of participants who achieved a 3-line or greater improvement from baseline in the study eye with no loss in best-corrected distance visual acuity (BCDVA) at 5 letters or more of distance vision (at 4 months) as measured at 3 hours post-treatment.
For a rundown on those studies, see our coverage.
And the gist of those findings?
Released in March 2024, the company reported that LNZ100 achieved all its primary and secondary near-vision improvement endpoints in both phase 3 trials.
The primary endpoint (3 hours post-treatment):
- CLARITY 1: 64% and 83% of participants achieved three- and two-lines or greater improvement, respectively
- CLARITY 2: 71% and 91% of participants achieved three- and two-lines or greater improvement, respectively
Plus: LNZ100 was found to be well tolerated with no serious treatment-related adverse events (TRAEs) noted following 30,000+ treatment days of monitoring.
So what’s the significance of this?
LENZ President and CEO Eef Schimmelpennink noted the potential of LNZ100 as a “pupil-selective and long-lasting therapeutic option” for treating presbyopia.
And what’s next?
Now we wait! The FDA has 60 days to review the NDA submission and determine whether it’s complete and acceptable (see what they’ll look for).
If found successful, this would pave the way toward an eventual regulatory approval and U.S. commercialization.