aceclidine (LNZ100) / LENZ Therap, CORXEL, Alvogen - LARVOL DELTA

LENZ Therapeutics and Lotus Pharmaceutical Announce Exclusive License and Commercialization Agreement for LNZ100 in the Republic of Korea and Southeast Asia (GlobeNewswire) - "LENZ Therapeutics, Inc...and Lotus Pharmaceutical Co., Ltd....today announced an exclusive license and commercialization agreement for Lotus to commercialize LNZ100 for the treatment of presbyopia in the Republic of Korea and certain countries in Southeast Asia....Under the terms of the licensing and commercialization agreement, LENZ will receive up to $125 million in upfront, regulatory and commercial milestone payments, as well as tiered, double-digit royalties on future net sales. Lotus will have exclusive development, manufacturing, registration and commercialization rights for LNZ100 for the treatment of presbyopia in the Republic of Korea and certain countries in Southeast Asia, including Thailand, Philippines, Vietnam, Malaysia, Brunei, Indonesia and Singapore....The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100, and noted it is not planning to hold an Advisory Committee Meeting to discuss this application."

Licensing / partnership • PDUFA • Ophthalmology

Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia (clinicaltrials.gov) - P3 | N=300 | Completed | Sponsor: Corxel Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology

LENZ Therapeutics Announces FDA Acceptance of New Drug Application for LNZ100 for the Treatment of Presbyopia (GlobeNewswire) - "LENZ Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for LNZ100 for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100. The FDA noted that it is not planning to hold an advisory committee meeting to discuss this application....The NDA submission for the treatment of presbyopia is supported by the positive data results from the pivotal Phase 3 CLARITY study."

FDA filing • PDUFA • Ophthalmology

Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia (clinicaltrials.gov) - P3 | N=300 | Active, not recruiting | Sponsor: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology

LENZ Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for LNZ100 for the Treatment of Presbyopia (GlobeNewswire) - "LENZ Therapeutics, Inc...announced that the Company has submitted a New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for LNZ100 (an aceclidine-based ophthalmic solution) for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States....The NDA submission is supported by positive data from the pivotal Phase 3 CLARITY study of LNZ100 for the treatment of presbyopia."

FDA filing • Ophthalmology

Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Chinese With Presbyopia (clinicaltrials.gov) - P1 | N=21 | Completed | Sponsor: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Apr 2024 | Trial primary completion date: Jul 2024 ➔ Apr 2024

Trial completion • Trial completion date • Trial primary completion date • Ophthalmology

Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Chinese With Presbyopia (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Ophthalmology

Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects With Presbyopia (clinicaltrials.gov) - P1 | N=21 | Not yet recruiting | Sponsor: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

New P1 trial • Ophthalmology

CLARITY: Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia (clinicaltrials.gov) - P3 | N=469 | Completed | Sponsor: LENZ Therapeutics, Inc | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology

CLARITY: Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia (clinicaltrials.gov) - P3 | N=469 | Active, not recruiting | Sponsor: LENZ Therapeutics, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology

Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Ophthalmology

Plasma Pharmacokinetics and Safety of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: LENZ Therapeutics, Inc | Recruiting ➔ Completed

Trial completion • Ophthalmology

Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

New P3 trial • Ophthalmology

Plasma Pharmacokinetics and Safety of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: LENZ Therapeutics, Inc

New P1 trial • Ophthalmology

Plasma Pharmacokinetics and Safety of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: LENZ Therapeutics, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Ophthalmology

Evaluation of the Safety and Effectiveness of Aceclidine (LNZ101) and Aceclidine + Brimonidine (LNZ100) in the Treatment of Presbyopia (clinicaltrials.gov) - P2 | N=58 | Completed | Sponsor: Alisyn Facemire | Recruiting ➔ Completed

Trial completion • Ophthalmology

CLARITY: Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia (clinicaltrials.gov) - P3 | N=435 | Recruiting | Sponsor: LENZ Therapeutics, Inc

New P3 trial • Ophthalmology

Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia (clinicaltrials.gov) - P2 | N=62 | Completed | Sponsor: LENZ Therapeutics, Inc | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology

Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia (clinicaltrials.gov) - P2 | N=61 | Active, not recruiting | Sponsor: LENZ Therapeutics, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology