Company: PTHS
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001753926-25-001326
Chunk: 119

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 8
Chunk 119
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 eye,

    ●
    side effects from
    photorefractive keratectomy (PRK) and pterygium surgery,

    ●
    second eye cataract
    surgery,

    ●
    neuropathic corneal
    pain, and

    ●
    severe uveitis and
    severe iritis/scleritis.

As
NaV1.7 channels are present on the cornea and is a viable biological target for treating eye pain, Pelthos believes that it has
a sound scientific basis for its ability to treat a multitude of eye pain indications. It has successfully developed an eye drop
formulation and has determined that the eye drops are well tolerated by animals.

28 

Pelthos
has two completed animal efficacy studies and are in the process of completing pivotal IND enabling ophthalmic toxicology studies.
The efficacy studies are as follows:

Trial
One 

In
the first trial, rabbits were treated with capsaicin (i.e., Pepper spray) to mimic an acute ocular insult in a common, validated
model for acute eye pain studies. Following the capsaicin treatment, the rabbits were treated with CT2000, which was dosed four
times over a 24-hour period. Pain was measured by the number of paw wipes over 60 seconds (paw wipes are a recognized surrogate
of eye pain in animal models). The results showed that CT2000 significantly reduced the number of paw wipes within 15 minutes
of administration of capsaicin and that CT2000 continued to show efficacy over a 60-minute period following administration. This
eye pain model was only validated for a short duration, with the results summarized in the following graph: 

Trial
Two 

In
the second trial, benzalkonium chloride (“BAC”) was instilled in mice eyes over a multiday period to create a model
of dry eye disease (the study was repeated twice). BAC is a detergent that irritates the eyes and simulates dry eye disease. As
with the capsaicin model summarized above, increased paw wipes over 60 seconds are a surrogate to measure ocular pain. Following
the induction of dry eye using BAC, the mice were dosed with CT2000 four times per day for 7 days. CT2000 reduced the frequency
of paw wipes within a single day of administration and showed cumulative efficacy over time (the analgesic effect appeared to
f