Article

NDA Granted to Glaucoma Drug

As we go to press, the FDA has approved the New Drug Application (NDA) of topical BAK-free latanoprost ophthalmic emulsion 0.005% (XELPROS, Sun Pharma) as an open-angle glaucoma or ocular hypertension first-line treatment. (See sunpharma.com )

The recommended dosage is once daily at night. IOP decrease: three to four hours later with the maximum result after eight to 12 hours.

Eye pain/stinging (55%) upon instillation and ocular hyperemia (41%) were the most frequently reported ocular adverse reactions. ■