The pace of new glaucoma drug development continues, fueled by continuing research into novel mechanisms of action. Three companies, Aerie Pharmaceuticals, Bausch + Lomb, and Inotek Pharmaceuticals, shared their latest results during “New Horizons in Glaucoma Pharmaceuticals” at the 2016 Glaucoma 360 meeting.
Aerie is staking its future on glaucoma, said Tom Mitro, president and chief operation officer. Two products, Rhopressa and Roclatan, are moving toward FDA submission.
“Rhopressa will be positioned as an additive to prostaglandin therapy,” Mitro said. “That market is 16 million to 17 million prescriptions annually in the United States alone. The current market is made up of products 20 to 30 years old that require two or more times daily dosing and can have some serious systemic side effects.”
More from Glaucoma 360: Value-Based Payment program presents potential ramifications
Rhopressa is a once-daily eye drop that inhibits Rho kinase (ROCK) and norepinephrine transporter (NET). Both are novel targets for the lowering of IOP and combine three distinct mechanisms of action.
ROCK inhibition increases fluid outflow through the trabecular meshwork and reduces episcleral venous pressure, while NET inhibition reduces production of aqueous. The NET inhibition effect makes Rhopressa helpful in patients with extremely high IOP, Mitro said.
Two phase III registration trials showed Rhopressa used once daily is not inferior to timolol used twice daily in patients with an IOP of less than 25 mm Hg. The company expects to file a New Drug Application in the third quarter of 2016.
More from Glaucoma 360: FDA making changes in approval processes for industry, patients
Roclatan is a fixed-dose combination of Rhopressa plus latanoprost. Phase IIb results suggest that Roclatan has the potential to become the most efficacious, IOP-lowering agent in the market, Mitro said.
Roclatan also showed strong effects in patients who had used a prostaglandin prior to clinical trials. After a washout period at the beginning of trials, patients who had previously used a prostaglandin showed the greatest IOP-lower effect compared to all other subgroups. One of two planned U.S. phase III trials is currently enrolling and a second began enrolling during the second quarter. An E.U.-based phase III trial is scheduled to begin during the second quarter of 2017.