Novaliq Gains US Approval of Vevye for the Signs and Symptoms of Dry Eye — Novaliq's Vevye

Novaliq, of Heidelberg, Germany, reported June 8 that the US FDA had approved Vevye (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease. June 8 was the target action date.

Vevye, formerly called CyclASol, is a topical anti-inflammatory and immunomodulating solution in Novaliq’s water-free, preservative-free EyeSol delivery vehicle.

Novaliq has said drops formulated with EyeSol do not induce blinking or tearing, so the drug stays on the eye longer.

The approval is a second milestone win for Novaliq in three weeks, following FDA approval on May 18 of Bausch + Lomb’s Miebo (perfluorohex-yloctane ophthalmic solution), formerly NOV03, for the signs and symptoms of dry eye. Bausch + Lomb licensed Miebo from Novaliq in 2019 for the US and Canada.

Miebo also is a water-free, preservative-free drop based on the EyeSol technology.

Novaliq calls the two products complementary, describing Miebo as a tear film stabilizer to prevent excessive tear evaporation and restore tear balance in evaporative dry eye, while Vevye is a powerful and comfortable drug with rapid onset, designed to address inflammatory dry eye.

Vevye also is intended to address corneal surface damage resulting from the chronic inflammatory nature of dry eye.

John D. Sheppard, MD, an investigator in the development program, said in Novaliq’s announcement that Vevye’s clinical trials consistently showed significant improvement in ocular surface damage and associated symptoms.

Novaliq has said it intends to seek approval for Vevye in other geographies, including the European Union.

In China, the candidate was exclusively licensed to Hengrui in November 2019, and a Phase III study began in March 2021.

A third dry eye drop using the EyeSol technology, NovaTears, is marketed by Ursapharm as EvoTears under CE-approval in Europe and by AFT Pharmaceuticals as NovaTears in Australia and New Zealand.

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