Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aceclidine+ Brimonidine · 7 trials · 8 indications
Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision on Day 1
Number and Percentage of Participants with at least one Treatment-Related Treatment-Emergent Adverse Events (TEAE) were collected by systematic assessment and coded using MedDRA.
Proportion of subjects with at least a 3 line (15 letter) improvement in near visual acuity in the study eye at 1 hour post-treatment in the mITT population
Maximum plasma concentrations of LNZ100 and LNZ101
Time of maximum plasma concentrations of LNZ100 and LNZ101
Area under the concentration-time curve from time 0 to time t of LNZ100 and LNZ100
Area under the concentration-time curve from time 0 to infinity of LNZ100 and LNZ101
Terminal half-life of LNZ100 and LNZ101
| Arm | Type | Description |
|---|---|---|
| Aceclidine + Brimonidine (LNZ101) dosed bilaterally | EXPERIMENTAL | LNZ101: Aceclidine + Brimonidine ophthalmic solution |
| Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally | EXPERIMENTAL | LNZ100: Aceclidine ophthalmic solution |
| Vehicle Ophthalmic Solution dosed bilaterally | EXPERIMENTAL | Vehicle ophthalmic solution |
| Brimonidine ophthalmic solution dosed bilaterally | EXPERIMENTAL | Brimonidine ophthalmic solution |
| Combination ophthalmic solution (LNZ101) dosed bilaterally | EXPERIMENTAL | LNZ 101: Aceclidine/Brimonidine combination ophthalmic solution |
| Aceclidine+tropicamide combination | EXPERIMENTAL | Aceclidine+tropicamide combination single dose (PRX-100 Ophthalmic Solution) |
| Aceclidine | ACTIVE_COMPARATOR | Aceclidine single dose |
| Vehicle | SHAM_COMPARATOR | Vehicle single dose |
| LNZ101 | OTHER | Aceclidine 1.75% / Brimonidine combination (non-preserved) ophthalmic solution |
| LNZ100 | OTHER | Aceclidine 1.75% (non-preserved) ophthalmic solution |
| Name | Type | Description |
|---|---|---|
| Aceclidine+Brimonidine combination ophthalmic solution | DRUG | Aceclidine + Brimonidine combination ophthalmic solution |
| Aceclidine ophthalmic solution | DRUG | Aceclidine ophthalmic solution |
| Vehicle | DRUG | Proprietary vehicle ophthalmic solution |
| Brimonidine | DRUG | Brimonidine ophthalmic solution |
| Vehicle proprietary ophthalmic solution | DRUG | Proprietary Vehicle ophthalmic solution |
| Aceclidine+tropicamide combination | DRUG | Ophthalmic Solution |
| Aceclidine | DRUG | Ophthalmic Solution |
| Aceclidine + Brimonidine | DRUG | LNZ101 (Aceclidine/Brimonidine) non-preserved ophthalmic solution |
Inclusion Criteria: Subjects MUST: 1. Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed; 2. Be able and willing to follow all instructions and attend all study visits; 3....
Aceclidine+Brimonidine is an investigational ophthalmic small molecule combination being developed by LENZ Therapeutics, Inc. (ticker: LENZ) for presbyopia and other eye diseases. It is designed as a topical eye drop. The combination has been studied in completed clinical trials, including Phase 3 studies, but is not approved for marketing.
Aceclidine+Brimonidine is being developed for the treatment of presbyopia, a common age-related eye condition that reduces near vision. It is also being studied in the broader category of eye diseases. The investigational therapy is intended for adults with presbyopia, with clinical trials enrolling participants aged 45 years and older.
Aceclidine+Brimonidine is being developed by LENZ Therapeutics, Inc., a biopharmaceutical company that trades under the ticker symbol LENZ. LENZ Therapeutics is focused on developing therapies for presbyopia and other vision conditions. The company is the sponsor of the clinical trials evaluating this ophthalmic combination.
Aceclidine+Brimonidine has been evaluated in Phase 1 and Phase 3 clinical trials. The Phase 3 trials have been completed, and the Phase 1 trial has also been completed. As of the available information, the drug remains investigational and is not approved by the FDA for any indication.
Aceclidine+Brimonidine has been studied in several completed clinical trials, including NCT05936489 (Phase 1), NCT05753189 (Phase 3), NCT05728944 (Phase 3), and NCT05656027 (Phase 3). These trials enrolled adults with presbyopia and were conducted in the United States. All listed trials are completed.