Moderate to severe dry eye improves after treatment with PL9643 in phase 2 study
Patients with moderate to severe dry eye disease experienced statistically significant improvement in signs and symptoms after 2 weeks of dosing with PL9643 and at the 12-week visit, Palatin Technologies announced in a press release.
However, the primary endpoints were not achieved in the phase 2 study in the overall population of patients with mild, moderate and severe dry eye disease at 12 weeks.
The multicenter, randomized, double-masked, vehicle-controlled study enrolled 160 patients who were randomly assigned to receive PL9643 or vehicle. The prespecified endpoints included inferior corneal straining and ocular discomfort.
In 61 patients with moderate to severe disease, the treatment achieved statistical significance vs. vehicle at week 2 and week 12 for signs such as inferior, superior and total corneal staining, temporal, nasal and total conjunctival staining and tear film breakup time and for ocular symptoms such as ocular discomfort (P < .05).
No serious or ocular drug-related adverse events were seen in the subjects who received PL9643.
“This was our first study evaluating a melanocortin agonist in an ocular disease, and we are pleased that the key goals of this study were met, which was providing significant clinical evidence of efficacy, safety and tolerability in a meaningful patient population — patients suffering from moderate to severe DED,” Carl Spana, PhD, president and CEO of Palatin, said in the release.
Palatin plans to initiate a phase 2/3 trial in the U.S. in mid-2021.
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