Melanocortin receptor pan-agonist improves dry eye signs, symptoms

Melanocortin receptor pan-agonist improves dry eye signs, symptoms

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Kenyon K, et al. Efficacy and safety of the melanocortin agonist PL9643 in a phase 2 study of subjects with dry eye disease. Presented at: Association for Research in Vision and Ophthalmology annual meeting; May 1-7, 2021 (virtual meeting).


Disclosures:
Kenyon reports he is a consultant for Ora.


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PL9643, a melanocortin receptor pan-agonist, improved subjective and objective outcomes within 2 weeks of treatment in patients with moderate or severe dry eye disease, according to a study.

In his presentation at the virtual Association for Research in Vision and Ophthalmology meeting, Kenneth Kenyon, MD, said that current therapies inadequately address the multifactorial inflammation and aqueous deficiency that affect patients with dry eye disease.





“The melanocortins are a new and particularly exciting group of compounds that are notable for their anti-inflammatory properties,” he said. “Acting by the inhibition of leukocyte activation, they protect tissues from the inflammatory response and, thus, may represent a novel, therapeutic avenue for the treatment of ocular inflammatory diseases.”

Patients with mild, moderate or severe dry eye disease first underwent a 2-week run-in period in which they all received a placebo solution. After that, researchers randomly assigned selected patients to receive either placebo or PL9643 topical ophthalmic solution (Palatin Technologies) bilaterally three times daily for 12 weeks.

The primary endpoints of the study were changes in inferior corneal fluorescein staining and ocular discomfort using the Ora Calibra scale after 12 weeks. Investigators also assessed changes in additional signs and symptoms of dry eye after 2 weeks and 12 weeks. They evaluated efficacy endpoints in an intent-to-treat population (160 patients) and in a subset of patients with moderate or severe dry eye disease (61 patients).

Kenyon and colleagues observed no significant improvements in corneal staining or ocular discomfort after 12 weeks in the overall intent-to-treat population. However, among patients with moderate or severe dry eye, they found improvements in inferior corneal fluorescein staining (P < .05). They also saw improvements in other signs, including superior and total corneal staining and temporal and total conjunctival staining, and symptoms, including ocular discomfort, after 2 weeks or 12 weeks.

Patients who received PL9643 experienced fewer adverse events compared with the placebo group, and none of the patients who received the drug reported any ocular instillation pain.

“These positive results across multiple signs and symptoms of dry eye very enthusiastically support the continued development of PL9643 as a novel therapeutic option for dry eye disease,” Kenyon said.

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