June 2021
Volume 62, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2021
Efficacy and Safety of the Melanocortin Agonist PL9643 in a Phase 2 Study of Subjects With Dry Eye Disease
Author Affiliations & Notes
  • Kenneth Kenyon
    Tufts University School of Medicine and New England Eye Center, Boston, Massachusetts, United States
    Ora Inc, Andover, Massachusetts, United States
  • George W Ousler
    Ora Inc, Andover, Massachusetts, United States
  • Michael Watson
    Ora Inc, Andover, Massachusetts, United States
  • Gail Torkildsen
    Andover Eye Associates, Andover, Massachusetts, United States
  • Patrick Vollmer
    Core Inc, Shelby, North Carolina, United States
  • Eugene B McLaurin
    Total Eye Care, Memphis, Tennessee, United States
  • David Evans
    Total Eye Care, Memphis, Tennessee, United States
  • Jason Winters
    Palatin Technologies Inc, Cranbury, New Jersey, United States
  • John Dodd
    Palatin Technologies Inc, Cranbury, New Jersey, United States
  • Robert Jordan
    Palatin Technologies Inc, Cranbury, New Jersey, United States
  • Stephen Wills
    Palatin Technologies Inc, Cranbury, New Jersey, United States
  • Carl Spana
    Palatin Technologies Inc, Cranbury, New Jersey, United States
  • Footnotes
    Commercial Relationships   Kenneth Kenyon, Ora Inc (C); George Ousler, Ora Inc (E); Michael Watson, Ora Inc (E); Gail Torkildsen, Aerie (F), Aldeyra (F), Allergan (F), Aurinia (F), Brim (F), Hanall (F), Kowa (F), Mitotech (F), Novaliq (F), Ora Inc (F), Oyster Point (F), Palatin (F), Regentree (F), Topivert (F); Patrick Vollmer, None; Eugene McLaurin, Aldeyra (F), Allergan (F), Aurinia (F), HanAll (F), Mallinckrodt (F), Mitotech (F), Nicox (F), Novaliq (F), Ocular Therapeutix (F), Orasis (F), Palatin (F), RegenTree (F), Santen (F), Topivert (F); David Evans, Alcon (F), Allergan (F), AxeroVision (F), Bausch & Lomb (F), Hovione (F), Kala (F), Novaliq (F), Novartis (F), Ocular Therapeutix (F), Vistakon (F); Jason Winters, Palatin Technologies Inc (E); John Dodd, Palatin Technologies Inc (E); Robert Jordan, Palatin Technologies Inc (E); Stephen Wills, Palatin Technologies Inc (E); Carl Spana, Palatin Technologies Inc (E)
  • Footnotes
    Support  Palatin Technologies Inc
Investigative Ophthalmology & Visual Science June 2021, Vol.62, 1333. doi:
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      Kenneth Kenyon, George W Ousler, Michael Watson, Gail Torkildsen, Patrick Vollmer, Eugene B McLaurin, David Evans, Jason Winters, John Dodd, Robert Jordan, Stephen Wills, Carl Spana; Efficacy and Safety of the Melanocortin Agonist PL9643 in a Phase 2 Study of Subjects With Dry Eye Disease. Invest. Ophthalmol. Vis. Sci. 2021;62(8):1333.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Dry eye disease is a multifactorial inflammatory and aqueous tear deficiency characterized by ocular irritation and potential visual impairment. As melanocortin agonists may represent a novel therapeutic avenue to treat inflammatory ocular diseases, this phase 2 study evaluated efficacy and tolerability of the melanocortin receptor pan-agonist PL9643 in adults with dry eye disease.

Methods : This randomized, placebo-controlled, double-masked study enrolled subjects with mild, moderate, or severe dry eye disease. All subjects received placebo solution (vehicle diluent) during a 2-week run-in period; selected subjects were then randomized 1:1 to receive either placebo or PL9643 topical ophthalmic solution bilaterally 3 times daily for 12 weeks. Co-primary endpoints were changes in inferior corneal fluorescein staining and ocular discomfort (Ora Calibra® scale) after 12 weeks. Secondary endpoints were changes in additional signs and symptoms of dry eye after 2 and 12 weeks, as well as the occurrence of adverse events (AEs) throughout the study. Efficacy endpoints were evaluated in the intent-to-treat (ITT) population and in the subset of subjects with moderate or severe dry eye disease.

Results : In the overall ITT population (N=160), significant improvements in corneal staining or ocular discomfort were not observed after 12 weeks. However, in the subset of subjects with moderate or severe disease (n=61), significant improvements were observed in the primary sign endpoint, inferior corneal fluorescein staining (LS mean difference [SEM], –0.5 [0.2], P<0.05), as well as in multiple other signs (superior and total corneal staining; temporal and total conjunctival staining) and symptoms (ocular discomfort) after 2 or 12 weeks. No treatment-related serious or ocular AEs were observed, and no subjects receiving PL9643 reported ocular instillation pain. Fewer AEs occurred among subjects receiving PL9643 compared with placebo.

Conclusions : In subjects with moderate or severe dry eye disease, ophthalmic PL9643 solution led to significant subjective and objective benefits by the first evaluation at 2 weeks and maintained for 12 weeks. PL9643 was well tolerated, with a safety profile comparable to placebo. Positive results across multiple signs and symptoms support the continued development of PL9643 as a novel therapeutic method for treating dry eye disease.

This is a 2021 ARVO Annual Meeting abstract.

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