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Young Companies Look to Shake Up Global Glaucoma Market

Firms ready first new treatments in 20 years

For the first time in two decades, patients with glaucoma may soon have new treatments as several young companies look to shake up the $5.6 billion global market, according to a report from Reuters.

There is no cure for glaucoma, which damages the optic nerve and is expected to affect more than 4 million Americans by 2030, up from 2.7 million today.

The new treatments promise to improve outcomes and to reduce the adverse effects associated with current medications, exploiting a long dearth of innovative new products for the disease. No new class of glaucoma therapy has been introduced since Pfizer’s Xalatan –– now available generically as latanoprost –– in 1996.

The newcomers aim to disrupt market-leaders Alcon (a division of Novartis), Allergan, Pfizer, and Valeant Pharmaceuticals International.

Leading the pack is Aerie Pharmaceuticals, which plans to launch its new eye-drop product Rhopressa in 2017 and another treatment, Roclatan, a year later.

Rhopressa is a once-daily treatment that inhibits Rho kinase (ROCK) and the norepinephrine transporter (NET) –– two novel biochemical targets for lowering intraocular pressure (IOP). By inhibiting these targets, Rhopressa is believed to reduce IOP via three separate mechanisms of action (MOAs): 1) through ROCK inhibition, it increases fluid outflow through the trabecular meshwork, which accounts for approximately 80% of fluid drainage from the eye; 2) as demonstrated in a recent preclinical study, it reduces episcleral venous pressure, which represents the pressure of the blood in the episcleral veins of the eye where eye fluid drains into the bloodstream; and 3) through NET inhibition, it reduces the production of eye fluid.

Roclatan, a single-drop, fixed-dose combination of Rhopressa and latanoprost, lowers IOP through the same three MOAs as Rhopressa and, as a fourth MOA, through the ability of latanoprost to increase fluid outflow through the uveoscleral pathway, the eye’s secondary drain. If approved, Roclatan would be the only glaucoma product that covers the full spectrum of currently known IOP-lowering MOAs.

Following Aerie is Inotek Pharmaceuticals, whose trabodenoson eye drop is entering phase III trials, which are expected to be completed by 2017. Trabodenoson (formerly known as INO-8875) is a selective adenosine mimetic acting only at the A1 receptor subtype. It is the first of a new class of compounds designed to lower IOP with an MOA that augments the natural function of the trabecular meshwork.

Taking a different approach is Ocular Therapeutix, which is developing a tiny device, called an anterior-segment punctum plug, that can be inserted into the eye to deliver travoprost for up to 90 days to treat glaucoma. The device is in mid-stage clinical trials.

The new wave of innovation comes as big drug-makers are consolidating or getting out of the eye-care market altogether.

The most promising of the big-company products may be Bausch & Lomb’s Vesneo (latanoprostene bunod), which builds on existing therapies and could be on the market by next year. It combines latanoprost with nitric oxide to add an extra pressure-lowering boost.

Firms are also working on new drug-delivery mechanisms. Allergan’s bimatoprost SR is in late-stage clinical trials and could become the first long-acting implant to reach the market. The product is a sustained-release prostamide-loaded, bioerodible implant that is injected into the anterior chamber of the eye. The procedure can be performed in the office.

Sources: Reuters; February 10, 2015; Aerie Pharmaceuticals; 2015; Inotek Pharmaceuticals; 2015; Ocular Therapeutics; 2015; Valeant Pharmaceuticals International; September 25, 2014; and Allergan; June 30, 2014.

 

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