As part of its fourth quarter and full-year earnings results reporting, Aerie Pharmaceuticals provided updates on several of its products in clinical development, including:
- Rhopressa (netarsudil ophthalmic solution) 0.02% NDA (new drug application) filing was resubmitted on February, 28, 2017, with a standard 1-year FDA review expected from the date of resubmission.
- Topline 6-month efficacy and safety data from Rocket 4, the Rhopressa phase 3 clinical trial designed to provide adequate safety data for European regulatory filings, are expected in the second quarter of 2017.
- Topline 90-day efficacy and safety data from the second phase 3 clinical trial for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, named Mercury 2, are also expected in the second quarter of 2017. If both Mercury 1 and Mercury 2 are successful, the Roclatan NDA is expected to be filed in late 2017 or early 2018.
- As of December 31, 2016, Aerie had $233.7 million in cash, cash equivalents, and investments. For the full year ended December 31, 2016, cash burn totaled $84.9 million, in line with our previous guidance of $85 million.
- Cash burn for 2017 is expected to approximate $100 million and includes the previously announced $16 million in Ireland manufacturing plant capital build-out costs. Projected operating expenses for 2017 are similar to 2016, with increased commercialization and scale-up expenses offset by reductions in clinical spend.
“We are off to a great start in 2017, with over $230 million in cash and investments, our Rhopressa NDA resubmitted, and our readouts from Rocket 4 and Mercury 2 on track for the second quarter of this year. We also look forward to commencing our first European clinical trial for Roclatan, known as Mercury 3, in mid-2017,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer, said in a company news release. “Our strategic initiatives, including our ongoing review of drug delivery technologies, our progress in defining our clinical trial path forward in Japan, and the commencement of build-out of our Ireland manufacturing plant, are also all proceeding on plan.”