Newer glaucoma medication classes about to be a reality?

Newer glaucoma medication classes about to be a reality?
While our podcast this week examines the rise of Glaukos and the MIGs market, contributor Michelle Dalton presents a State of the Glaucoma Drugs address.

With no new classes of drugs to treat glaucoma introduced since the mid-1990s, clinicians and Wall Street are waiting for the next “big thing” to hit the market. Reuters places the global glaucoma marketplace at around $5.6 billion. The U.S. market alone is expected to grow to 4 million patients by 2030—up from 2.7 million in 2015.

GlobalData is a bit more bullish, expecting the market to grow to about $3 billion by 2023, with the U.S. share comprising almost 72%. MarketScope may be the most ambitious, predicting the global glaucoma pharmaceutical market to grow from about $5 billion in 2015 to more than $6.1 billion in 2020, with the majority of growth coming from outside the U.S. in China, India, and Latin America.

Driving this growth will be the introductions of new classes of drugs and newer fixed-dose combinations; this will continue to be offset by the increased used of generic latanoprost across the major worldwide markets. Since prostaglandins already have such a hold on the market, newcomers will have to show substantially improved efficacy to justify the increased costs when compared to the generic versions. Wall Street may not be swayed, but clinicians will be if the newer drugs also improve the notoriously poor patient compliance aspect.

In one of its reports, Frost & Sullivan said the prostaglandin analog market share held nearly 60% of the glaucoma market, leaving quite a bit of room for others to elbow in. Still, plenty of companies are working on newer formulations of prostaglandins.

Companies in later-stage (phase 3 or later) development:

Aerie Pharmaceuticals– Rhopressa, a novel eye drop described as a triple-action Rho-Kinase (ROCK)/norepinephrine transporter (NET) inhibitor and plans to launch the drug in 2017. Phase 3 registration trials for quadruple-action prostaglandin analog (PGA) Roclatan, a combination of Rhopressa and latanoprost, expected to launch in 2017. The company sold 6.7 million shares for $10 each in its 2013 market debut. They now top $26. Potential annual sales for these two are estimated between $600 million combined to $1 billion each, depending on the source.

Bausch + Lomb—Vesneo (latanoprost bunod), a new drug class of nitric oxide donating prostaglandin analogue, was submitted for US regulatory approval in mid-July.

Inotek—Trabodeson, a first-in-class selective adenosine mimetic designed to restore the eye’s natural pressure control mechanism, is now in phase 3 studies. Inotek’s stock jumped 65% after news the company had completed an end-of-phase 2 meeting with the FDA and initiated plans for a phase 3 study. Early predictions on potential sales are around $300 million or so.

Nephron Pharmaceuticals Corp.—T-2345, non-preserved latanoprost 0.005%, completed phase 3 studies earlier this year. Nephron is predominantly known for manufacturing generic respiratory drugs; this is the first venture into ophthalmics. Privately held Nephron provides no estimates on T-2345, but a common concern among glaucoma clinicians is the potential for topical medications to cause (or exacerbate) dry eye during chronic, long-term use as a result of the preservatives used.