FDA approves first BAK-free formulation of latanoprost

Regulatory officials have approved Xelpros 0.005%, a first-line treatment for open-angle glaucoma and ocular hypertension that lacks the preservative benzalkonium chloride (BAK).

Developed by Sun Pharma’s R&D division, Sun Pharma Advanced Research Company Ltd (SPARC), the once-daily eyedrop relies on a proprietary swollen micelle microemulsion technology to boost the solubility of latanoprost, a drug that typically requires BAK to stay in solution. The formulation remains stable at room temperature and could reduce the risk of BAK-associated ocular surface disease.

“As the only BAK-free version of latanoprost, Xelpros will be an important and alternative treatment option for individuals with open-angle glaucoma or ocular hypertension,” said Abhay Gandhi, CEO, North America, Sun Pharma.

The approval comes after a randomized, controlled trial found that Xelpros lowered IOP by an average of 6-8 mmHg in affected patients who had an average baseline IOP of 23-26 mmHg. The drop begins to reduce IOP in about 3 hours, with maximum effects reached by 12 hours. According to SPARC’s website, Xelpros was found to be as efficacious and as safe as Xalatan in a head-to-head comparison.

Xelpros will be commercialized in the United States by Sun Ophthalmics, the branded ophthalmic division of Sun Pharma.