Company: PTHS
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001753926-25-001326
Chunk: 160

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 2
Chunk 160
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. Pelthos intends to explore the viability
of developing CT2000 as a topical agent for the relief of eye pain. A potential advantage of this approach is that topical administration
of CT2000 is unlikely to lead to any hypersensitivity or skin reactions, like what was noted with systemic administration of CC8464,
because the systemic absorption from a topical administration would be extremely limited. Pelthos has developed topical ophthalmic
formulations and are pursuing trial plans as set forth below.

Current
options for the treatment of ocular pain center on the use of corticosteroids and non-steroidal anti-inflammatory drug (“NSAID”)
based therapeutics. These options suffer from sight-threatening complications such as Glaucoma and corneal melting, thus there
is a large unmet need for other approaches. As an example of the potential patient population, Pelthos estimates that there are
approximately 5 million cases of corneal abrasions per year in the United States. In addition, other potential indications associated
with eye pain include:

    ●
    severe dry 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