Corneal wound healing treatment enters phase 2 trial

DURHAM, N.C. — A phase 2 trial of diquafosol tetrasodium for corneal wound healing has begun, according to the drug’s developer, Inspire Pharmaceuticals.

The company will also initiate two phase 2 trials of another compound, denufosol tetrasodium, for the treatment of macular edema. A trial of denufosol for retinal detachment has been discontinued due to low patient enrollment, the company said in a press release.

“Inspire remains committed to exploring multiple opportunities for P2 receptor-based therapies targeting ophthalmic therapeutic needs,” said Christy L. Shaffer, PhD, chief executive officer of Inspire, in the press release.

“There is scientific support for the corneal epithelial wound healing potential of P2Y2 receptor agonists based on reduction of corneal staining in dry eye clinical trials and experimental work conducted by independent researchers,” the press release stated. Inspire said diquafosol might be useful in numerous corneal epithelial wound healing applications, including ocular surgery, corneal abrasions and epithelial defects.

In April, Inspire began enrolling patients in a phase 2 trial of diquafosol 2% vs. placebo to evaluate the efficacy of the compound in improving corneal wound healing following PRK. About 30 patients undergoing bilateral PRK for the treatment of myopia will participate, the press release said. Results are expected by the end of the year.

Denufosol tetrasodium is another P2Y2 receptor agonist under investigation as an intravitreal injection for the treatment of diseases associated with accumulation of fluid in or around the retina, the company said. The first of two phase 2 trials is expected to begin over the next few weeks, according to Inspire. The treatment group for this trial includes patients with uveitis and persistent macular edema. A second phase 2 trial will test the compound in patients with persistent macular edema following cataract surgery.