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

LENZ Therapeutics Announces NMPA Submission of New Drug Application for LNZ100 in China for the Treatment of Presbyopia (GlobeNewswire) - "LENZ Therapeutics, Inc...announced that CORXEL Pharmaceuticals ('CORXEL') has submitted the New Drug Application (NDA) for LNZ100 to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People’s Republic of China (PRC)...The NDA submission was supported by positive data from the Phase 3 JX07001 clinical trial of LNZ100 in patients with presbyopia in China...The submission of the NDA for LNZ100 results in the achievement of the first milestone under the License and Collaboration Agreement with CORXEL (the 'License')."

China filing • Ophthalmology

Lenz's Vizz wins FDA approval to crack 'large, untapped' market for presbyopia (Fierce Pharma) - "Lenz Therapeutics has earned the FDA’s go-ahead for its aceclidine eye drop to crack the large presbyopia market, where past efforts by other drug developers have mostly been unsuccessful. The aceclidine 1.44% solution is now cleared under the brand name Vizz to treat adults with presbyopia, a form of farsightedness that’s commonly known as age-related blurry near vision...While broader commercial supply will not be ready until around November, the company expects to offer samples of the drug as early as October...Two phase 3 trials of Vizz, dubbed Clarity 1 and 2, met all primary and secondary near vision improvement endpoints, showing the drug can improve near vision within 30 minutes and last up to 10 hours."

FDA approval • Ophthalmology

LENZ Therapeutics and Laboratoires Théa Announce Exclusive License and Commercialization Agreement for LNZ100 in Canada (GlobeNewswire) - "LENZ Therapeutics, Inc...and Laboratoires Théa...announced an exclusive license and commercialization agreement for Théa to register and commercialize LNZ100 for the treatment of presbyopia in Canada. LENZ Therapeutics is a pre-commercial stage biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, which has a US FDA PDUFA date of August 8, 2025."

Licensing / partnership • PDUFA • Ophthalmology

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