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I: Basic Product Information
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Category |
Details |
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Product Overview |
On July 28, 2025, LENZ Therapeutics announced that its partner, Ji Xing Pharmaceuticals (Corxel Pharmaceuticals), has submitted a New Drug Application (NDA) in China for LNZ100 ophthalmic solution (1.75% aceclidine) for the treatment of presbyopia (commonly known as age-related farsightedness). [If approved, this drug would become the first eye drop in China indicated for vision improvement!]{.mark} LNZ100 is an eye drop for presbyopia; its main component is aceclidine. This drug is a small molecule acetylcholine receptor agonist that [causes pupil contraction, creating a pinhole effect, thereby improving near vision.]{.mark} Presbyopia is an age-related physiological phenomenon where seeing nearby objects gradually becomes blurry. It occurs due to the gradual hardening and reduced elasticity of the eye's lens, coupled with the declining function of the ciliary muscle, leading to decreased accommodative ability. This prevents the eye from focusing images of near objects onto the retina, resulting in poor near vision. [Presbyopia is an inevitable age-related physiological process. Studies show its onset typically occurs around age 38, with a prevalence nearing 100% by age 52 (affecting approximately 1.8 billion people globally). Clinically, patients can choose from two correction methods based on need. The most common traditional method is wearing reading glasses or contact lenses. However, for today's middle-aged population seeking improved visual quality and work/life efficiency, reading glasses are often insufficient, leading more patients to explore surgical options or pharmacological treatments.]{.mark} Aceclidine hydrochloride is an eye drop requiring [just once-daily administration, offering significant improvement within 30 minutes of use, with effects lasting up to 10 hours.]{.mark} |
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Generic Name |
Aceclidine Hydrochloride |
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CAS Number |
6109-70-2 |
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Dosage Form & Strength |
Ophthalmic Solution 1.75% Aceclidine (single agent), 1.75% Aceclidine + 0.08% Brimonidine (combination) |
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Approval/Launch Date |
July 31, 2025 (Refers to NDA submission date in context; actual approval pending) |
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English Name |
Aceclidine hydrochloride |
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Originator/Developer |
LENZ Therapeutics Inc. |
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Key Excipients |
Polysorbate 80 (non-ionic surfactant, stabilizes solution, improves solubility, prevents protein precipitation, commonly used in ophthalmic formulations to reduce irritation), Mannitol (tonicity adjuster), Hypromellose (viscosity-increasing agent & humectant), Edetate disodium dihydrate (chelating agent), Sodium citrate dihydrate (buffering agent, enhances drug stability and ocular comfort), Water for Injection, Hydrochloric acid/Sodium hydroxide (pH 4.5~5.5). [Preservative-free. (Discard single-dose vial after opening)]{.mark} (Image: Excipients table - would be embedded here) |
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Formulation Assessment |
Stable Drug Type: Terminal sterilization process; formulation filled and sealed then sterilized (e.g., autoclaving). Heat-sensitive Drug Type: Aseptic processing throughout; solution filtered through 0.22μm membrane filter for sterilization, filled in Grade A clean environment. Ophthalmic surgical/trauma preparations: Single-dose ampoules, aseptic processing throughout without preservatives or buffers. Each single-dose container is made of transparent low-density polyethylene (LDPE). Five single-dose containers are packaged in an aluminum pouch. Carton packaging contains 25 single-dose containers (5 pouches x 5 units, 0.4 mL each). |
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Indications |
Presbyopia |
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Dosage & Administration |
Once daily. |
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Mechanism of Action / Target |
CHRM1 agonist; CHRM3 modulator |
Note: Based on Originator's Prescribing Information.
II: Patent Status
[No compound or crystal form patents for the active pharmaceutical ingredient (API) were identified in China currently. The formulation/composition patent expires in August 2034.]{.mark}
Note: Patent information sourced from CDE's marketed drug patent registry and Pharmadl.
III: Competitive Landscape Analysis
Global Innovative Drug Pipeline for Presbyopia
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Drug Name (Generic) |
Drug Type |
Target |
Approved Indications |
Indications in Development (Total) |
Originator / Developer |
Partner |
Highest Global Phase |
Global Phase Date |
Highest China Phase |
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Aceclidine hydrochloride |
Innovative Drug |
CHRM1; CHRM3 |
Presbyopia |
Presbyopia |
LENZ Therapeutics Inc |
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. |
Approved |
2025-07-31 |
Phase III |
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CBT-199 |
Innovative Drug |
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Presbyopia |
Cloudbreak Therapeutics LLC |
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Preclinical |
2025-01-03 |
None |
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CBT-145 |
Innovative Drug |
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Presbyopia |
Cloudbreak Therapeutics LLC |
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Preclinical |
2025-01-03 |
None |
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Aceclidine; Brimonidine tartrate |
Innovative Drug |
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Presbyopia |
LENZ Therapeutics Inc |
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. |
Phase III |
2022-12-09 |
Phase III |
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CBT-168 |
Innovative Drug |
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Presbyopia |
Bausch + Lomb Pharmaceutical (Guangzhou) Co., Ltd. |
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Preclinical |
2023-10-30 |
None |
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WO2023278464A1 |
Innovative Drug |
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Cataract; Presbyopia |
Plex |
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Preclinical |
2022-06-28 |
None |
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CLX-OPH-162 |
Innovative Drug |
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Presbyopia |
Cellix Bio Pvt Ltd |
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Preclinical |
2022-01-01 |
None |
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UNR-844 |
Innovative Drug |
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Presbyopia |
Encore Vision Inc; Novartis |
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Phase II |
2021-03-16 |
None |
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AGN-241622 |
Innovative Drug |
ADRA2 |
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Presbyopia |
AbbVie |
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Phase I |
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None |
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Presbysol |
Innovative Drug |
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Presbyopia |
AbbVie; Allergan |
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Phase III |
2019-05-07 |
None |
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Lipoic acid choline ester chloride |
Innovative Drug |
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Presbyopia |
Encore Vision Inc |
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Phase II |
2019-01-17 |
None |
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Aceclidine; Tropicamide |
Innovative Drug |
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Presbyopia |
LENZ Therapeutics Inc |
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Phase II |
2015-09-16 |
None |
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Oxymetazoline hydrochloride |
Innovative Drug |
ADRA1 |
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Presbyopia |
Allergan |
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Phase II |
2014-07-21 |
None |
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RTP-003B |
Innovative Drug |
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Cataract; Presbyopia |
Zhejiang Ruitong Biotechnology Co., Ltd. |
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Preclinical |
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None |
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SY-301 |
Innovative Drug |
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Presbyopia |
Guangdong Sage Kanghua Biopharmaceutical Co., Ltd. |
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Preclinical |
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None |
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TO-O-1005 |
Innovative Drug |
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Presbyopia |
Shuode Biotechnology Co., Ltd. |
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Preclinical |
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None |
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CLX-OPH-561 |
Innovative Drug |
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Presbyopia |
Cellix Bio Pvt Ltd |
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Preclinical |
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None |
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RTP-7 |
Innovative Drug |
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Presbyopia |
Zhejiang Ruitong Biotechnology Co., Ltd. |
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Preclinical |
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None |
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VP1-001 |
Innovative Drug |
CRYAB |
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Cataract; Presbyopia |
Tenpoint Therapeutics Ltd; ViewPoint Therapeutics |
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Preclinical |
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None |
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RTP-003A |
Innovative Drug |
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Presbyopia |
Zhejiang Ruitong Biotechnology Co., Ltd. |
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Preclinical |
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None |
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Undisclosed, Plex Pharmaceuticals(Presbyopia) |
Innovative Drug |
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Presbyopia |
Plex Pharmaceuticals |
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Preclinical |
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None |
Note: Data source: Pharmadl.
IV: API and Formulation Registration Status (Including Chinese Companies with FDA Filings)
[Active Pharmaceutical Ingredient (API)]{.mark}
[Domestic (China):]{.mark} None identified. (Based on searches, Yide Pharmaceutical has completed process validation and is awaiting filing; they source material internationally, focusing solely on the Chinese market.)
[International:]{.mark} Currently only 1 entity is filed with the FDA.
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Based on searches, currently 4 global suppliers can provide the API:
(Table: API Suppliers - would be embedded here)
[Formulation]{.mark}
[Domestic (China):]{.mark} Phase III clinical trials ongoing as of August 2023.
[International:]{.mark} Currently marketed only in the US.
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V: Synthesis Route and Key Intermediates
No corresponding synthesis route or intermediate information was retrieved.
VI: Market Information
According to the WHO's "World Report on Vision (2019)", globally, 1.8 billion people had presbyopia in 2015, including 826 million untreated cases. Studies show presbyopia onset typically occurs around age 38 (peaking at 42-44 years), with prevalence nearing 100% by age 52 (~1.8 billion people globally). According to the "2023 China Presbyopia Population Insight Report", 56.9% of China's population aged 35 and above, amounting to 390 million people, experience presbyopia. This indicates a vast potential drug market in the presbyopia space, with an estimated potential market size of approximately $28 billion USD.
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Note: Total number of presbyopia patients and proportion untreated by global region (units: millions). Source: WHO.
VII: Customs Data (Russia, India, Korea, Iran, USA)
Based on trade data queries, [no transaction records for this product were found for Russia, South Korea, or the USA.]{.mark} Trade activity for this product between India and China is relatively higher. Details below:
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VIII: Certificate of Analysis (COA)
Not available.
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