LENZ Therapeutics Announces Positive Topline Data from Phase 3 CLARITY Presbyopia Trials - Seite 2

“These positive CLARITY study data build on the compelling results from our INSIGHT trials, demonstrating a robust safety and efficacy profile for the use of aceclidine to treat presbyopia,” said Marc Odrich, Chief Medical Officer of LENZ Therapeutics. “Presbyopes often experience an abrupt change in their daily life as the symptoms become progressively pronounced starting in their mid-40s, when reading glasses or other corrective aids often become necessary to read, text or conduct close-up work. The statistically significant data and clinically meaningful outcomes observed in the CLARITY trials support the potential paradigm-shifting impact LNZ100 can have as an alternative and convenient therapeutic option to reading glasses.”

CLARITY Phase 3 Study Topline Data Highlights:

CLARITY is a Phase 3 multi-center, double-masked, randomized, controlled, efficacy and safety study for LNZ100 and LNZ101 for the treatment of presbyopia. It is comprised of two six-week efficacy trials, CLARITY 1 and 2, and a six-month safety trial, CLARITY 3. The trials enrolled a total of 1,059 participants ranging from ages 45 to 75, and a refractive range of -4.0D SE to +1.0D SE, and included users who previously had LASIK surgery or are pseudophakes. The primary efficacy endpoint in both CLARITY 1 and 2 is the percentage of participants who achieve three-lines or greater improvement in BCDVA at near without losing one-line (5 letters or more of distance vision) at 3 hours post-treatment.

In both the vehicle-controlled CLARITY 2 trial and the brimonidine-controlled CLARITY 1 trial, our lead product candidate LNZ100 (1.75% aceclidine) achieved all primary and secondary near vision improvement endpoints, including demonstrating (in all cases, p<0.0001):

• Rapid onset: at 30 minutes, for CLARITY 2, 71% and 91% of participants achieved three- and two-lines or greater improvement, respectively, and for CLARITY 1, 72% and 87% of participants achieved three- and two-lines or greater improvement, respectively;
• At 3 hours (primary endpoint for three-lines): for CLARITY 2, 71% and 91% of participants achieved three- and two-lines or greater improvement, respectively, and for CLARITY 1, 64% and 83% of participants achieved three- and two-lines or greater improvement, respectively; and
• Long duration: at 10 hours, for CLARITY 2, 40% and 69% of participants achieved three- and two-lines or greater improvement, respectively, and for CLARITY 1, 27% and 61% of participants achieved three- and two-lines or greater improvement, respectively.

Near vision improvement was reproducible and consistent across both CLARITY 1 and 2 throughout the four-week study periods.