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NOV03

First drug developed to treat signs and symptoms of evaporative dry eye disease

NOV03 (100% perfluorohexyloctane) is the first drug developed to treat dry eye disease (DED) associated with Meibomian gland dysfunction in a highly effective way.

NOV03 (100% perfluorohexyloctane) is the first drug developed to treat dry eye disease (DED) associated with Meibomian gland dysfunction in a highly effective way.

Since December 2019, Novaliq has a strategic cooperation with Bausch + Lomb to develop, manufacture and commercialize NOV03 in USA and Canada. In May 2023 MIEBO™ (perfluorohexyloctane ophthalmic solution; formerly known as NOV03) was approved for the treatment of the signs and symptoms of dry eye disease (DED) in the USA. MIEBO™ is the first and only FDA-approved treatment for DED that directly targets tear evaporation. See www.miebo.com for more information and prescription information. Bausch + Lomb Acquired the U.S. and Canadian Commercial rights from Novaliq in 2019. Approval in Canada was obtained in September 2024.

In China Novaliq has a strategic cooperation with Jiangsu Hengrui Pharmaceuticals to develop, manufacture and commercialize perfluorohexyloctane ophthalmic solution. In July 2025, the China National Medical Products Administration (NMPA) approved it under the brand name Heng Qin™ for the treatment of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). Heng Qin™ is the first and only drug approved to treat DED associated with MGD in China.

For Japan Novaliq partners with Senju Pharmaceutical Co., Ltd., a researched-based Japanese pharmaceutical company focusing the field of ophthalmology, to develop, manufacture, and commercialize NOV03 (perfluorohexyloctane ophthalmic solution), a first-in-class, preservative-free treatment for signs and symptoms of dry eye disease.

In the US Phase 3 studies (GOBI, MOJAVE) as well as the China bridging study (SHR8028-301), NOV03 met all primary and secondary endpoints, including improvement of:

  • Change from baseline in total Corneal Fluorescein Staining (tCFS), a measure of assessing damage to the cornea, achieved statistical significance at day 15, with continued results through day 57 compared to control
  • Change from baseline in dryness score achieved statistical significance at day 15, with continued results through day 57 compared to control, as rated on a visual analogue scale (VAS)
  • NOV03 was well tolerated. The most common ocular adverse reaction was blurred vision reported in about 3% of individuals across studies.

These studies confirmed all efficacy and safety results from the previous Phase 2 SEECASE trial.

Publications

more information about the clinical trials.

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