Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 931

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 4
Chunk 931
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, making it a viable biological target for treating eye pain.
Eye pain may occur with various conditions, including severe dry eye disease, trauma and surgery. Existing therapies for eye pain
(such as steroids, topical non-steroidal anti-inflammatory agents, lubricants, local anesthetics) are limited in their effectiveness
and/or limited in the duration that they may be prescribed because of safety issues. We intend 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. We have 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, we estimate 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, we believe that we have a sound
scientific basis for our ability to treat a multitude of eye pain indications. We have successfully developed an eye drop formulation
and have determined that the eye drops are well tolerated by animals. We have completed animal efficacy studies and are in the
process of running toxicology studies on animals. We expect to announce the efficacy and toxicology results by April 2025.

Following
the animal studies, if successful, we intend to move into POC studies in humans. We plan to conduct the POC study in Australia
to avail ourselves of