Our lead product candidate, Rhopressa® (netarsudil ophthalmic solution) 0.02% was approved by the FDA in December 2017. Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, is currently in the late stages of development. If the current Phase 3 trials for Roclatan™ ophthalmic solution continue to be successful, the Company expects to file an NDA for this product candidate in the second quarter of 2018.
Rhopressa® (netarsudil ophthalmic solution) 0.02%
Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02% / 0.005%
Roclatan™ 1 2 4, (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% is a once-daily eye drop that combines Rhopressa® ophthalmic solution, as described above, with latanoprost, a widely-prescribed PGA. Based on our preclinical studies and clinical trials to date, we believe that Roclatan™ ophthalmic solution, if approved, would be the first glaucoma product to lower IOP through all known mechanisms: (i) increasing fluid outflow through the trabecular meshwork, the eye’s primary drain, (ii) increasing fluid outflow through the uveoscleral pathway, the eye’s secondary drain, (iii) potentially reducing fluid production in the eye, and (iv) reducing episcleral venous pressure (EVP). By covering the full spectrum of known IOP-lowering mechanisms, Roclatan™ ophthalmic solution has the potential to provide a greater IOP-lowering effect than any currently approved glaucoma product. The first Phase 3 registration trial for Roclatan™ ophthalmic solution, named Mercury 1 was a 12-month safety trial, which had a successful 90-day efficacy readout in September 2016. The topline efficacy readout from Mercury 1 demonstrated that Roclatan™ ophthalmic solution was statistically superior to each of its components with IOP-lowering beyond the comparators in the range of 1 to 3 mmHg.5 The second Phase 3 registration trial, named Mercury 2, was a 90-day efficacy trial that was completed in May 2017. The study also achieved its primary efficacy endpoint demonstrating statistical superiority beyond the comparators in the range of 1 to 3 mmHg. A third Phase 3 registration trial, named Mercury 3, commenced in Europe in the third quarter of 2017. Mercury 3 is not necessary for approval in the U.S., but rather to facilitate regulatory approval and commercialization in Europe. Mercury 3 is designed to compare Roclatan™ to Ganfort®, a fixed-dose combination product of bimatoprost and timolol marketed in Europe, which if successful, is expected to improve our commercialization prospects in that region.
- Wang RF, Williamson JE, Kopczynski C, Serle JB. Effect of 0.04% AR-13324, a ROCK, and norepinephrine transporter inhibitor, on aqueous humor dynamics in normotensive monkey eyes. J Glaucoma 2015. 24(1):51-4.
- Kiel JW, Kopczynski C. Effect of AR-13324 on Episcleral Venous Pressure (EVP) in Dutch Belted Rabbits. J Ocul Pharmacol Ther 2015; 31(3):146-151.
- Sturdivant JM,* Royalty SR, Lin CW, Moore LA, Yingling JD, Laethem CL, Sherman B, Heintzelman GR, Kopczynski CC, deLong M. Discovery of the ROCK inhibitor netarsudil for the treatment of open-angle glaucoma. Bioorg Med Chem Lett. 2016; 26:2475–2480.
- Xalatan® Package Insert Revised November 2014.
- This topline Mercury 1 data was also included in the resubmitted Rhopressa® NDA as supportive