Exactly two months after receiving FDA approval, Alcon announced the U.S. commercial launch of TRYPTYR (acoltremon ophthalmic solution) 0.003%, indicated for the treatment of the signs and symptoms of dry eye disease (DED).
How exciting! First, tell me about this solution.
For the formulation: TRYPTYR’s active ingredient is acoltremon, a transient receptor potential melastatin 8 agonist (TRPM8) formulated for topical ocular instillation.
As a refresh on TRPM8, it:
- Is a protein located in an ion channel within the cornea and eyelid
- Acts as a thermoreceptor that responds to cold temperatures and cooling agents, playing a key role in such physiological processes like pain perception
- Is a cold-sensing receptor known to activate trigeminal nerve signaling when stimulated—resulting in increased basal tear production (see this mechanism of action … in action)
- In fact, the TRPM8 channel is referred to as the “master regulator of basal tear production”
So in a nutshell: TRYPTYR rapidly increases tear production by stimulating corneal sensory nerves.
Now more about the product itself.
Packaged in single-dose vials (which should be discarded immediately after use), this ophthalmic solution is the company’s first prescription-based pharmaceutical.
In terms of dosing:
- Per its prescribing information (PI), one drop should be instilled in each eye, twice daily (BID; an estimated 12 hours apart)
- Contact lenses should be removed prior to instilling the drops into each eye—and only reinserted 15 minutes after instillation
- Other topical ophthalmic drops can be used concomitantly with TRYPTYR
- However: If using more than one topical drop, administer each at least 5 minutes apart
So what makes this drop unique?
Most notably, TRYPTYR is making waves as the first topical neuromodulator (thanks to its use of acoltremon, the TRPM8 receptor agonist) to rapidly increase natural tear production—as early as the first day of use.
Talk more about that rapid onset.
This is based on clinical data findings that supported the drop’s FDA approval.
Phase 3 results from the COMET-2 (NCT05285644) and COMET-3 (NCT05360966) studies both demonstrated “a rapid onset and sustained tear production” following TRYPTYR administration (versus vehicle).
- To note, these results were observed as early as Day 14 and lasted through Day 90, with up to four times as many TRYPTYR patients experiencing at least a 10 mm increase in natural tear production at Day 14 of use versus vehicle.
- Check out more findings from our coverage on these studies
Do we know anything about this tear production increase beyond 90 days?
We do, actually. In fact, phase 3 data from yet another COMET study (this time COMET-4 [NCT05493111]) evaluated tear production among TRYTYR users through 12 months.
As an aside: To coincide with this product launch, Alcon is also introducing an awareness campaign for patients and eyecare providers (ECPs) on the new class of TRP8M receptor-targeting eye drops.
Any potential side or adverse effects to be aware of?
The most common adverse reaction during these trials: instillation site pain (occurring in 50% of patients)
Alrighty, now to the non-clinical details: How much will TRYPTYR cost?
Per the product’s savings page, eligible patients can receive their first fill of TRYPTYR for free via a trial program at BlinkRx, a free digital pharmacy service.
How that works:
- An ECP will send a patient’s prescription to BlinkRx
- The patient will then receive a text with a link to enroll in the program and receive the lowest available pricing (accessible via eligible discounts)
- Then, the prescription eye drop will be delivered (for free) to a patient’s home
And the price following that initial fill?
ECPs are advised to reach out to their local Alcon representative.