The committee voted 10-0 in favor of efficacy and 9-1 in favor of safety.
The US Food and Drug Administration’s Dermatologic and Ophthalmologic Drugs Advisory Committee voted in favor of netarsudil ophthalmic solution 0.02% (Rhopressa, Aerie) on Friday.
Aerie Pharmaceuticals, which produces the solution, is seeking an indication for reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The advisory committee voted 10-0 in favor of the efficacy of the solution and 9-1 in favor of the safety.
“We are delighted with the outcome of the FDA’s Advisory Committee, and we now have our sights set on the February 28th PDUFA date,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, said in a statement. “We believe there are significant unmet needs in the treatment of patients with open-angle glaucoma or ocular hypertension, and we are very excited about the prospects for Rhopressa.”
The decision was made based on data from the Rocket 2 and Rocket 1 trials, phase 3 registration studies included in the New Drug Application (NDA) for netarsudil ophthalmic solution 0.02%. The results, which compared the once-a-day solution (n=129) to timolol twice-a-day (n=142), showed that the solution had a consistent level of IOP lowering from day 90 through 12 months (nominal variance 0.1 mmHg).
The average diurnal IOP in the solution arm was 21.4 mmHg, decreased to 17.4 mmHg at day 90. Changes were seen as early as week 2, and the patient retention through 3 months was 85% for the solution compared to 94% for timolol. Keeping with previous studies, the most common adverse event was conjunctival hyperemia, though it was considered mild in 83% of occurrences, and remained similar to incidences reported in similar studies with topical prostaglandins.
The solution’s Prescription Drug User Fee Act (PDUFA) date is currently set for February 28, 2018.