23 May 2023 - - The US Food and Drug Administration has approved MIEBO (perfluorohexyloctane ophthalmic solution; formerly known as NOV03), for the treatment of the signs and symptoms of dry eye disease. MIEBO is the first and only FDA-approved treatment for DED that directly targets tear evaporation, eye health company Bausch + Lomb Corp. (NYSE: BLCO) (TSX: BLCO) and German biopharmaceutical company Novaliq GmbH said.

DED affects millions of Americans and is one of the most common ocular surface disorders.

A leading cause of DED is excessive tear evaporation, which due to an altered tear lipid layer, is often associated with the clinical signs of Meibomian gland dysfunction.

An unstable tear film triggers increased ocular surface desiccation, inflammation and damage to the ocular surface.

MIEBO is designed to reduce tear evaporation at the ocular surface.

In GOBI and MOJAVE, two phase 3 pivotal clinical trials which enrolled more than 1,200 patients (randomized 1: 1 to MIEBO or hypotonic saline) with a history of DED and clinical signs of MGD, MIEBO consistently met its primary clinical sign and patient-reported symptom endpoint.

The FDA approval of MIEBO was based on results from two 57-day, multi-center, randomized, double-masked, saline-controlled studies, GOBI and MOJAVE, which enrolled a total of 1,217 patients with a history of DED and clinical signs of MGD, a major cause of development and disease progression.

An estimated 86% of people with DED have excessive tear evaporation whereby MGD is the major contributor.

In the GOBI and MOJAVE phase 3 pivotal studies, MIEBO met both primary sign and symptom efficacy endpoints.

The two primary endpoints were change from baseline at week eight (day 57 ± 2) in total corneal fluorescein staining and eye dryness Visual Analog Scale score. Patients experienced relief of symptoms as early as day 15 and through day 57 with statistically significant reduction in VAS eye dryness score favoring MIEBO observed in both studies.

Additionally, at days 15 and day 57, a significant reduction in tCFS favoring MIEBO was observed in both studies.

The most common adverse reactions experienced with MIEBO were blurred vision (1.3-3%) and eye redness.

MIEBO (perfluorohexyloctane ophthalmic solution) is used to treat the signs and symptoms of dry eye disease.

Novaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol, the worldwide first water-free technology.

Novaliq GmbH is headquartered in Heidelberg, Germany and Novaliq Inc. has an office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies.

Bausch + Lomb's portfolio of more than 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments.

Founded in 1853, Bausch + Lomb has a global research and development, manufacturing and commercial footprint with approximately 13,000 employees and a presence in nearly 100 countries.

Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey.