FDA Acceptance of NDA for LNZ100
LENZ received FDA acceptance of NDA for LNZ100 for presbyopia treatment with a PDUFA target action date of August 8th, 2025.
Positive Phase 3 CLARITY Trial Results
LNZ100 demonstrated a rapid onset with 71% achieving three lines of near vision improvement at 30 minutes and three hours, 95% achieved at least two lines of improvement, and 69% maintained improvement after 10 hours.
Strong Safety Profile of LNZ100
LNZ100 was well-tolerated with no treatment-related serious adverse events reported over 30,000 treatment days, and 95% of adverse events were mild and transient.
Market Research Indicating Strong ECP Support
78% of eye care professionals surveyed found LNZ100 to be an attractive and safe presbyopia treatment, with 83% likely to sample and 82% likely to prescribe.
Strong Financial Position
LENZ completed a $30 million PIPE financing, ending Q3 2024 with $217.2 million in cash, cash equivalents, and marketable securities, funding the company to post-launch positive operating cash flow.