LENZ Therapeutics, Inc. announced an exclusive license and commercialization agreement with Laboratoires Théa for LNZ100, its investigational presbyopia eye drop, in Canada.
First up: Refresh me on these players.
We’ll start with Théa—a European pharmaceutical company specializing in the research, development, and commercialization of ophthalmic products available across 75 countries.
- To note: Its U.S. subsidiary is Thea Pharma, Inc.
LENZ is a late-stage biopharmaceutical company headquartered in San Diego, California, focused on advancing two presbyopia therapeutic candidates—most prominently: the development and commercialization of LNZ100, the first and only aceclidine-based eye drop for presbyopia.
- And in (relatively) recent news: The company merged with Graphite Bio, Inc. in 2024.
Talk more about LNZ100.
As the first of LENZ’s two presbyopia candidates, LNZ100 is formulated as a preservative-free (PF), single-use, and once-daily eye drop.
- Its unique component is the key active ingredient: aceclidine (with a 1.75% concentration).
- See here for some background on its long-standing efficacy (though it has yet to be approved for presbyopia in any country)
About aceclidine: Referred to by LENZ as a “pupil selective miotic,” this is a small-molecule acetylcholine receptor that causes miosis (excessive constriction of the pupil)—which, in turn, is intended to result in a “pinhole” effect that:
- Improves near vision
- Prevents a myopic shift
We’ll get to its clinical data in a moment.
So what does this agreement entail?
We’ll break it down by what’s in it for both companies:
- For Théa: The company will acquire the exclusive development, manufacturing, registration, and commercialization rights for LNZ100 to treat presbyopia in Canada
- For LENZ: The company will be eligible to receive +$70 million in upfront, regulatory, and commercial milestone payments—along with tiered, double-digit royalties on net sales
Take note: This marks the third commercialization partnership LENZ has entered into for LNZ00 outside of the United States (see here for its previous agreements in the Republic of Korea and certain Southeast Asian countries).
Just to be clear: This eye drop has yet to be approved in any country, correct?
That’s correct. However, back in the United States, LENZ submitted a new drug application (NDA) to the FDA last summer that the federal agency accepted for review in October 2024.
- Notably, there have been no delays or interruptions in this review process.
With a Prescription Drug User Fee Act (PDUFA) data set for next month (Aug. 8), the company is hoping to receive FDA approval in the United States by (or before) then.
Got it. So what clinical data was used to support this NDA submission?
That would be positive findings from the phase 3 CLARITY program—conducted in partnership with Ora, Inc.—involving the CLARITY 1 study (NCT05656027) and CLARITY 2 safety study (NCT05753189).
- Conducted over 6 weeks, these efficacy trials met their primary and secondary near-vision improvement endpoints. Check out the full data report here.
And when does the company anticipate a U.S. commercial launch?
When announcing the FDA’s NDA acceptance, LENZ President and CEO Eef Schimmelpennink had noted an anticipated (potential) launch of LNZ100 as early as H2 2025.
How about in Canada?
No specific timeline or timeframe has been established as yet—so stay tuned!