The long-awaited start of the sustained drug-release era in glaucoma medication arrived in 2020 with Allergan’s launch of Durysta, a bimatoprost sustained release device. The launch came wrapped in restrictions and hopes, but nonetheless began a new era in glaucoma treatment.
Durysta will have limited clinical impact on the field as it is restricted to a one-time use per eye, but it paved the regulatory and reimbursement pathways for other devices to follow, and other devices are following. A travoprost sustained release device from Glaukos is in Phase III clinical trials that are expected to reach primary completion in 2021. Glaukos aims to launch the iDose TR device commercially in 2023, provided it clears all regulatory hurdles. At least 18 companies––from startups and small cap companies to such large companies as Allergan (with a second device) and Santen––are in line behind Glaukos with 22 product candidates in development.
Many of those will run into regulatory hurdles, but some will clear the course to market, where they will transform glaucoma treatment. Allergan aimed for four months’ efficacy with Durysta, but found the effects lasted much longer in some patients. Glaukos aims for two years with iDose TR. Other product candidates target six months or one year of efficacy. Any of those could be an attractive alternative to daily eye drops.
Sustained drug release appears to be the main hope for growing revenues in glaucoma pharmaceuticals. Global revenue from brand name proprietary glaucoma medicines fell another 11.9 percent in 2020 as generic drugs continued to take market share from proprietary products. Proprietary drugs introduced since 2017––Vyzulta, Eybelis, Rhopressa, and Rocklatan––continue to increase sales, but still account for less than 5 percent of global sales revenue.
Market Scope estimates total manufacturer revenue from glaucoma pharmaceuticals, both branded drugs and generics, shrank 1.8 percent in 2020, but expects growth to resume in 2021 as manufacturers expand markets for newer products and patients resume normal eye care visits after COVID-19 is brought under control.
The changing dynamics of the glaucoma pharmaceuticals segment are captured in Market Scope's “2021 Glaucoma Pharmaceuticals Market Report.”
Bausch + Lomb aims for more regulatory approvals for Vyzulta and looks to follow the commercial launch of Vyzulta in Mexico in January 2021 with launches in Colombia, Hong Kong, Taiwan, and Ukraine, where the product has already received regulatory approvals. Sales started in the US in 2018 and Canada in 2019.
Aerie Pharmaceuticals, which launched Rhopressa in the US in May 2018, and Rocklatan in May 2019, cleared European Union regulatory approval for Rhokiinsa (Rhopressa) in November 2019 and Roclanda (Rocklatan) in January 2021. Aerie licensed marketing rights to the two drugs in Japan and some other Asian countries to Santen in 2020. Santen aims to launch Rhopressa in Japan in 2024 and Rocklatan in 2026.
Santen began commercial sales in Japan of Eybelis, licensed from Ube Industries, in 2018. Commercial sales began in South Korea in February 2021. Santen also has filed for marketing approval in other Asian countries. A Phase III trial in the US for FDA regulators was scheduled to end on Dec. 31, 2020.
Bausch + Lomb, Aerie, and Santen all increased sales of their glaucoma medicines in 2020. Aerie, the newest player in the market, had the largest percentage increase, an estimated 22 percent increase over 2019. Novartis and Allergan, the two dominant players in the glaucoma drug market, saw their sales revenue drop. Neither company had new products on the market. Novartis had the largest percentage decrease, estimated at 15 percent, due mostly to rising generic competition since it lost patent protection on its travoprost compound.