MIEBO is the first and only prescribed drop that directly targets dry eye diseases (DED)

United States: On Thursday, 18th May 2023, Bausch + Lomb Corporation, a global eye care company dedicated to help people for better vision to live better, and Novaliq GmbH, a biopharmaceutical company dedicated for the development of ocular therapeutics, have officially announced that the FDA has approved MIEBO, a perfluorohexyloctane ophthalmic solution which was formerly known as NOV03. This solution is utilized for the treatment of signs and symptoms of dry eyes diseases (DED).  MIEBO is the first remedy which directly targets tear evaporation.  The excessive tear evaporation is due to an altered tear lipid layer which is associated with the clinical signs of Meibomian Gland Dysfunction (MGD). The increasing ocular surface desiccation, inflammation, and damage to the ocular surface, are due to formation of an unstable tear film. Therefore, with the approval of MIEBO, eye care professionals have developed a new approach to DED therapy that specifically addresses tear evaporation.

The development of this solution was based on results from two 57-day, multi-center, randomized, double-masked, saline-controlled studies, i.e., 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. The approval was based on data from the phase 3 studies, in which MIEBO met both primary sign and symptom efficacy endpoints. The two primary endpoints were changed from baseline at week eight (day 57 ± 2) in total corneal fluorescein staining (tCFS) and eye dryness Visual Analog Scale (VAS) score. 

According to the Founder & CEO of Bausch + Lomb Corporation, "Today’s FDA approval of MIEBO further advances DED treatment by addressing a significant unmet need for millions of people suffering with this disease. We are proud to bring to market the first and only prescription eye drop approved in the United States for the treatment of DED that directly targets evaporation. We expect to make Miebo commercially available in the second half of this year.”

According to the CEO of Novaliq GmBH, “We believe that MIEBO will address a significant unmet need for the many Americans who struggle with evaporative dry eye”.

According to TechSci Research, the FDA approval for the MIEBO will provide the company a competitive edge in the vision care market. Product launches have always been a key strategy followed by different companies operating in a particular industry to maintain a strong market positioning and hold. The healthcare industry has witnessed a lot of innovative product launches in recent years and is still witnessing a lot. Also, a product launch provides an opportunity to generate buzz and increase awareness about the company and its offerings. This can lead to greater visibility within the healthcare industry, attracting attention from potential customers, investors, and partners. By expanding their facilities, vision care companies can produce more products and potentially capture a larger market share. With larger and more modern product launches, vision care companies can achieve economies of scale, optimize their production processes, and lower per-unit costs. This can enhance their competitiveness and profitability in the market.

The approval of MIEBO has made Bausch + Lomb Corporation, a research and development company, headquartered in Vaughan, Ontario that focused on the manufacturing and commercialization of biopharmaceutical products.  and Novaliq GmBH, a biopharmaceutical company, headquartered in Heidelberg, Germany that addressed today's medical needs of millions of patients with eye diseases. The company is focused on the development and commercialization of first- and best-in-class ocular therapeutics.