Novartis gains right to topical myopia treatment

BASEL, Switzerland — Novartis Ophthalmics has acquired the rights to market pirenzepine, a drug for the treatment of myopia. Novartis will own worldwide marketing rights to the drug, currently in phase 2 trials by developer Valley Forge Pharmaceuticals.

Pirenzepine is described in a press release from Novartis as “a relatively selective muscarinic M1 receptor antagonist administered as an eye gel twice a day.” The drug is expected to reduce the progression of myopia by up to 50%, according to the press release.

A multicenter phase 2 trial of the drug has enrolled 174 children aged 8 to 12, with myopia in both eyes. The mean baseline cycloplegic refractive error was –2.04 D in the right eye and –2.05 D in the left eye. Children were randomized to receive 2% pirenzepine ophthalmic gel or vehicle for 1 year. Key measures of efficacy will include cycloplegic autorefraction, axial length by ultrasonography, visual acuity, biomicroscopy, indirect ophthalmoscopy, pupil diameter and intraocular pressure.

According the Novartis release, phase 2 trials have shown the drug to reduce the progression of myopia by at least 50% in the first 12 months of therapy.

“This novel compound … could set new standards for the treatment of this eye disorder, since there is no pharmacological therapy available today,” said Flemming Ørnskov, head of Novartis Ophthalmics.

Valley Forge Pharmaceuticals is still enrolling patients in its international trial for the compound.