Everest Medicines acquires Greater China rights to Aceclidine Presbyopia Eye Drop (VIZZ)

Everest Medicines, a Hong Kong–listed biopharmaceutical company, has agreed to acquire from Corxel Pharmaceuticals the rights to develop, manufacture, and commercialize aceclidine ophthalmic solution 1.44% (VIZZ; LENZ Therapeutics) in Greater China—encompassing the Chinese mainland, Hong Kong SAR, Macao SAR, and Taiwan. The announcement marks a pivotal step in the global rollout of the first aceclidine-based pharmacological therapy for presbyopia, a near-universal age-related condition affecting an estimated 1.8 billion people worldwide.¹

For eye care clinicians, the development is noteworthy not primarily for its commercial structure but because it signals continued regulatory momentum for aceclidine in a market where presbyopia management remains dominated by spectacle correction. A New Drug Application (NDA) for aceclidine ophthalmic solution was submitted to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) in September 2025, following Phase 3 data generated by Corxel in the Chinese patient population; regulatory approval is anticipated in the first quarter of 2027.

Trial and regulatory background

Aceclidine ophthalmic solution received US FDA approval in July 2025, supported by data from the pivotal Phase 3 CLARITY program.^2,3 In the CLARITY 1 and CLARITY 2 efficacy trials, the 1.44% met its primary endpoint: a statistically significant proportion of participants achieved a ≥3-line improvement in monocular best-corrected distance visual acuity (BCDVA) at near without losing ≥1 line in distance visual acuity.⁴ In CLARITY 2, 71% of LNZ100-treated participants achieved this threshold at 3 hours post-dose, with 40% maintaining that level of improvement at 10 hours.⁴ No serious treatment-related adverse events were reported across more than 30,000 treatment days in the combined CLARITY dataset.⁴

The China-specific Phase 3 program, designated JX07001, was a multicenter, randomized, double-blind, vehicle-controlled study conducted by Corxel that enrolled Chinese adults with presbyopia. The trial followed a 4-week efficacy period and a 5-month extension safety period.⁵ Topline data announced in October 2024 showed that LNZ100 met its primary endpoint and key secondary endpoints in this population: 74% of treated participants achieved a ≥3-line improvement in BCDVA at near at 3 hours post-dose, and participants maintained optimal distance visual acuity (defined as no loss of ≥5 letters).⁵ The consistency of these results with those observed in the US CLARITY program across a different ethnic population and study design adds meaningful external validity to the efficacy profile, though cross-trial comparisons must be interpreted with appropriate caution given differences in population characteristics, study design, and measurement conditions.

Clinical context: presbyopia and the treatment landscape

Presbyopia, the age-related progressive loss of accommodative amplitude, affects virtually all individuals by the sixth decade of life. A 2024 British Contact Lens Association (BCLA) CLEAR report estimated global functional presbyopia prevalence at approximately 1.8 billion in 2015, with projections of 2.1 billion by 2030.¹ In China alone, the rapidly aging population constitutes one of the largest untreated presbyopia cohorts in the world.

Prior to the emergence of pharmacological miotic drops, management of presbyopia was confined to spectacle correction (reading glasses and progressive lenses), contact lens strategies (monovision and multifocal lenses), and surgical approaches including laser vision correction and refractive lens exchange. Each modality carries limitations—spectacles require removal and handling, monovision contact lenses involve a compromise of binocular distance acuity, and surgical options carry procedural risk. The introduction of once-daily topical pharmacotherapy has created a new treatment category in the United States and potentially in China.

In the US market, 3 miotic eye drops now carry FDA approval for presbyopia: pilocarpine 1.25% (Vuity; AbbVie), pilocarpine 0.4% (Qlosi; Orasis Pharmaceuticals), and aceclidine 1.44% (VIZZ). No pharmacological presbyopia treatment has yet received NMPA approval. If aceclidine receives approval as anticipated in early 2027, it would represent the first such agent approved in China—a market where spectacle correction has historically been the near-exclusive non-surgical option.

Drug background: mechanism of action and selectivity profile

Aceclidine is a direct-acting muscarinic agonist and a new chemical entity in the United States, where it was not previously approved for any indication prior to the VIZZ NDA.² Its proposed differentiation within the miotic drug class lies in its preferential affinity for the iris sphincter muscle relative to the ciliary body. In preclinical and clinical characterization, aceclidine has been described as a predominantly pupil-selective miotic: it contracts the iris sphincter to achieve a consistent sub-2mm pupil diameter, generating a pinhole effect that extends depth of focus and improves near vision, while demonstrating limited stimulation of the ciliary muscle.^3,4

This mechanistic selectivity is clinically relevant because ciliary muscle contraction—the mechanism underlying pilocarpine's induced pseudoaccommodation—has been associated with a myopic shift and headache in some patients. Whether the reduced ciliary muscle engagement of aceclidine translates into a meaningfully differentiated tolerability advantage over pilocarpine in real-world practice has not been directly established in head-to-head trials. A 2025 systematic review and meta-analysis of pilocarpine ophthalmic solution for presbyopia published in the American Journal of Ophthalmology noted that headache and conjunctival hyperemia were the most commonly reported adverse events with pilocarpine-based therapies, occurring in more than 5% of participants in phase 3 data.⁸ The aceclidine CLARITY trials did not report serious treatment-related adverse events, though the approved prescribing information should be consulted for the complete safety characterization.

Commercial and licensing structure

Under the terms of the asset purchase agreement, Everest Medicines acquires the rights and obligations originally established under the LENZ-Corxel license agreement executed in April 2022. LENZ Therapeutics is eligible to receive up to $85.0 million in remaining regulatory and sales milestone payments, in addition to tiered mid-single-digit to low-double-digit royalties on net sales in Greater China. LENZ is also eligible for additional payments tied to the execution of the Corxel-Everest agreement itself.

Corxel's role in the transaction was primarily as clinical executor and regulatory steward of the China development program. The transfer of rights to Everest—a company with an established integrated commercialization platform in China across ophthalmology and other therapeutic areas—reflects a strategic move to place the asset with an organization that has commercialization infrastructure in the target market.

Interpretive considerations

Clinicians should interpret the commercial milestones announced here as a licensing and regulatory-readiness development rather than a clinical efficacy update. The Phase 3 JX07001 trial data, reported in October 2024, are the most relevant clinical reference for the Chinese program; full peer-reviewed publication of these results does not appear to have been identified in the literature at the time of this report, and clinicians should await that publication for a complete assessment of study design details, subgroup analyses, and the durability of the safety signal over the 5-month extension period.

The consistency between the JX07001 China data (74% responder rate at 3 hours) and the US CLARITY 2 results (71% responder rate at 3 hours) is reassuring with respect to ethnic and geographic generalizability, but the studies used slightly different primary endpoint parameters and were not powered for direct comparison.^4,5 Additionally, VIZZ has been commercially available in the US market only since October 2025, meaning real-world effectiveness, adherence, and long-term safety data remain limited at the time of publication.

The NMPA regulatory timeline—with NDA submission in September 2025 and approval targeted for Q1 2027—is subject to the standard uncertainties of the regulatory review process, including potential requests for additional data or manufacturing review timelines.

Limitations and outstanding questions

Several clinically meaningful questions remain unanswered. No published head-to-head trials comparing aceclidine to pilocarpine-based agents have been identified in the peer-reviewed literature. The long-term safety profile of once-daily aceclidine beyond 6 months in real-world use, including the risk of retinal detachment in predisposed populations (a known theoretical concern with any miotic agent), has not been systematically reported in publication form. Patient-reported outcome data quantifying the quality-of-life benefit are available from the CLARITY trials but have not yet been independently synthesized in peer-reviewed reviews. Finally, the question of how aceclidine will be positioned and priced within China's healthcare reimbursement framework remains open.

References

1. Wolffsohn JS, Bhatt U, Bhatt PR, et al. BCLA CLEAR Presbyopia: epidemiology and impact. Contact Lens Anterior Eye. 2024;47(4):102155. https://www.contactlensjournal.com/article/S1367-0484(24)00049-3/fulltext

2. U.S. Food and Drug Administration. VIZZ (aceclidine ophthalmic solution) 1.44%—NDA approval. July 31, 2025. SEC Form 8-K Exhibit 99.1. https://www.sec.gov/Archives/edgar/data/0001815776/000181577625000059/exhibit991-73125fdaapprova.htm

3. Drugs.com. Vizz (aceclidine) FDA approval history. https://www.drugs.com/history/vizz.html

4. LENZ Therapeutics, Inc. LENZ Therapeutics announces positive topline data from Phase 3 CLARITY presbyopia trials [press release]. April 3, 2024. https://ir.lenz-tx.com/news-events/press-releases/detail/11/lenz-therapeutics-announces-positive-topline-data-from-phase-3-clarity-presbyopia-trials

5. Corxel Pharmaceuticals; LENZ Therapeutics, Inc. CORXEL and LENZ Therapeutics announce positive topline data from China Phase 3 presbyopia trial of LNZ100 [press release]. October 27, 2024. https://ir.lenz-tx.com/news-events/press-releases/detail/23/corxel-and-lenz-therapeutics-announce-positive-topline-data-from-china-phase-3-presbyopia-trial-of-lnz100

6. AbbVie/Allergan. U.S. Food and Drug Administration approves VUITY (pilocarpine HCl ophthalmic solution 1.25%) for the treatment of presbyopia [press release]. October 29, 2021. https://news.abbvie.com/2021-10-29-U-S-Food-and-Drug-Administration-Approves-VUITY-TM-pilocarpine-HCI-ophthalmic-solution-1-25-,-the-First-and-Only-Eye-Drop-to-Treat-Presbyopia-Age-Related-Blurry-Near-Vision

7. Lavia LA, Bhatt DK, Braga-Mele R, Garg A. The emerging era of presbyopia-correcting eye drops: what's next? Ophthalmology Times. Published online 2026. https://www.ophthalmologytimes.com/view/the-emerging-era-of-presbyopia-correcting-eye-drops-what-s-next-

8. Patel S, Bhatt DK, Bhatt UK, et al. Short-term efficacy and safety of pilocarpine ophthalmic solution for presbyopia: a systematic review and meta-analysis. Am J Ophthalmol. 2025. https://www.ajo.com/article/S0002-9394(25)00439-8/abstract