Gulf News: UAE approves MIEBO

Published by The Daily Scout

What happened

- The Emirates Drug Establishment approved Bausch + Lomb’s MIEBO on May 16, making the UAE the third country to clear the dry-eye treatment. - MIEBO contains perfluorohexyloctane and is the first prescription eye drop that directly targets tear evaporation, a leading cause of dry eye disease. - The product appears in the Emirates Drug Establishment’s drug directory, while Bausch + Lomb markets MIEBO and Novaliq supplies the underlying technology.

Why it matters

The United Arab Emirates approved Bausch + Lomb’s MIEBO for dry eye disease on May 16, according to the Emirates Drug Establishment and state news agency WAM. The agency said the UAE is the third country to approve the product. Bausch + Lomb’s treatment contains perfluorohexyloctane and is indicated for the signs and symptoms of dry eye disease. The approval adds a prescription option in the UAE for patients whose disease is driven by tear evaporation rather than a simple lack of lubrication. ### What exactly did the UAE approve? The Emirates Drug Establishment said on May 16 that it approved MIEBO by Bausch + Lomb for the treatment of the signs and symptoms of dry eye disease. WAM described the move as part of an effort to expand patient access in the UAE to newer eye-care medicines. MIEBO contains perfluorohexyloctane, the active substance in the drop. The U.S. (wam.ae) Food and Drug Administration label describes MIEBO as a semifluorinated alkane ophthalmic solution, with dosing of one drop four times daily in affected eyes. ### Why is MIEBO treated differently from a standard artificial tear? MIEBO is positioned around tear evaporation. Gulf News and WAM said it is the first prescription eye drop that directly targets tear evaporation, which they described as one of the leading causes of dry eye disease. (wam.ae) Novaliq, which developed the underlying EyeSol technology, says perfluorohexyloctane is designed to stabilize the tear film and prevent excessive tear evaporation in dry eye disease associated with meibomian gland dysfunction. (accessdata.fda.gov) That matters because evaporative dry eye is typically linked to a problem in the eye’s lipid layer, not just an insufficient volume of tears. ### Is this really the third country to approve it? (gulfnews.com) WAM said on May 16 that the UAE became the third country globally to approve MIEBO. Gulf News used the same formulation in its report. The product has been marketed in other forms and under other brand names in some regions for years. Novaliq says NovaTears, also based on EyeSol, has been CE certified since 2013 and commercialized in Europe as EvoTears and in Australia and New Zealand as NovaTears. (novaliq.com) That suggests the “third country” description refers to approvals of the branded prescription product MIEBO, rather than the first availability anywhere of perfluorohexyloctane-based dry-eye drops. (wam.ae) ### Where else has MIEBO been cleared? The United States approved MIEBO in May 2023, according to the FDA label and a joint announcement from Bausch + Lomb and Novaliq. The companies said at the time that MIEBO was the first and only prescription eye drop approved in the United States to directly target tear evaporation. Bausch + Lomb’s U.S. product site still describes MIEBO as the only prescription eye drop that directly targets too much tear evaporation. (novaliq.com) That language matches the positioning used in the UAE reports. ### Why does this matter to eye doctors and cataract practices? Dry eye disease can affect visual quality, corneal surface regularity and preoperative measurements used in cataract planning. Novaliq says its perfluorohexyloctane product is aimed at dry eye disease associated with meibomian gland dysfunction, a common evaporative subtype. (accessdata.fda.gov) For ophthalmologists, that means the UAE approval adds another market where an evaporation-targeting prescription drop can be used as part of ocular-surface management. (miebo.com) The reports from WAM and Gulf News did not give a launch date, pricing or distributor timeline in the UAE, but the approval has already been reflected in the Emirates Drug Establishment’s drug directory, which lists registered medicines and approval details. (novaliq.com) The next concrete step is commercial rollout. Bausch + Lomb, which markets MIEBO, and the Emirates Drug Establishment’s directory will be the main public sources for launch details, registration status updates and any local prescribing information in the UAE. (ede.gov.ae)

Key numbers

  • The Emirates Drug Establishment approved Bausch + Lomb’s MIEBO on May 16, making the UAE the third country to clear the dry-eye treatment.
  • The United Arab Emirates approved Bausch + Lomb’s MIEBO for dry eye disease on May 16, according to the Emirates Drug Establishment and state news agency WAM.
  • The Emirates Drug Establishment said on May 16 that it approved MIEBO by Bausch + Lomb for the treatment of the signs and symptoms of dry eye disease.
  • (gulfnews.com) WAM said on May 16 that the UAE became the third country globally to approve MIEBO.

What happens next

  • The United Arab Emirates approved Bausch + Lomb’s MIEBO for dry eye disease on May 16, according to the Emirates Drug Establishment and state news agency WAM.
  • The Emirates Drug Establishment said on May 16 that it approved MIEBO by Bausch + Lomb for the treatment of the signs and symptoms of dry eye disease.
  • WAM described the move as part of an effort to expand patient access in the UAE to newer eye-care medicines.

Quick answers

What happened in Gulf News: UAE approves MIEBO?

The Emirates Drug Establishment approved Bausch + Lomb’s MIEBO on May 16, making the UAE the third country to clear the dry-eye treatment. MIEBO contains perfluorohexyloctane and is the first prescription eye drop that directly targets tear evaporation, a leading cause of dry eye disease. The product appears in the Emirates Drug Establishment’s drug directory, while Bausch + Lomb markets MIEBO and Novaliq supplies the underlying technology.

Why does Gulf News: UAE approves MIEBO matter?

The United Arab Emirates approved Bausch + Lomb’s MIEBO for dry eye disease on May 16, according to the Emirates Drug Establishment and state news agency WAM. The agency said the UAE is the third country to approve the product. Bausch + Lomb’s treatment contains perfluorohexyloctane and is indicated for the signs and symptoms of dry eye disease. The approval adds a prescription option in the UAE for patients whose disease is driven by tear evaporation rather than a simple lack of lubrication. What exactly did the UAE approve? The Emirates Drug Establishment said on May 16 that it approved MIEBO by Bausch + Lomb for the treatment of the signs and symptoms of dry eye disease. WAM described the move as part of an effort to expand patient access in the UAE to newer eye-care medicines. MIEBO contains perfluorohexyloctane, the active substance in the drop. The U.S. (wam.ae) Food and Drug Administration label describes MIEBO as a semifluorinated alkane ophthalmic solution, with dosing of one drop four times daily in affected eyes. Why is MIEBO treated differently from a standard artificial tear? MIEBO is positioned around tear evaporation. Gulf News and WAM said it is the first prescription eye drop that directly targets tear evaporation, which they described as one of the leading causes of dry eye disease. (wam.ae) Novaliq, which developed the underlying EyeSol technology, says perfluorohexyloctane is designed to stabilize the tear film and prevent excessive tear evaporation in dry eye disease associated with meibomian gland dysfunction. (accessdata.fda.gov) That matters because evaporative dry eye is typically linked to a problem in the eye’s lipid layer, not just an insufficient volume of tears. Is this really the third country to approve it? (gulfnews.com) WAM said on May 16 that the UAE became the third country globally to approve MIEBO. Gulf News used the same formulation in its report. The product has been marketed in other forms and under other brand names in some regions for years. Novaliq says NovaTears, also based on EyeSol, has been CE certified since 2013 and commercialized in Europe as EvoTears and in Australia and New Zealand as NovaTears. (novaliq.com) That suggests the “third country” description refers to approvals of the branded prescription product MIEBO, rather than the first availability anywhere of perfluorohexyloctane-based dry-eye drops. (wam.ae) Where else has MIEBO been cleared? The United States approved MIEBO in May 2023, according to the FDA label and a joint announcement from Bausch + Lomb and Novaliq. The companies said at the time that MIEBO was the first and only prescription eye drop approved in the United States to directly target tear evaporation. Bausch + Lomb’s U.S. product site still describes MIEBO as the only prescription eye drop that directly targets too much tear evaporation. (novaliq.com) That language matches the positioning used in the UAE reports. Why does this matter to eye doctors and cataract practices? Dry eye disease can affect visual quality, corneal surface regularity and preoperative measurements used in cataract planning. Novaliq says its perfluorohexyloctane product is aimed at dry eye disease associated with meibomian gland dysfunction, a common evaporative subtype. (accessdata.fda.gov) For ophthalmologists, that means the UAE approval adds another market where an evaporation-targeting prescription drop can be used as part of ocular-surface management. (miebo.com) The reports from WAM and Gulf News did not give a launch date, pricing or distributor timeline in the UAE, but the approval has already been reflected in the Emirates Drug Establishment’s drug directory, which lists registered medicines and approval details. (novaliq.com) The next concrete step is commercial rollout. Bausch + Lomb, which markets MIEBO, and the Emirates Drug Establishment’s directory will be the main public sources for launch details, registration status updates and any local prescribing information in the UAE. (ede.gov.ae)

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