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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 is expected in 2024 by Bausch + Lomb.

In China Novaliq has a strategic cooperation with Jiangsu Hengrui Pharmaceuticals to develop, manufacture and commercialize NOV03 for the treatment of dry eye disease in China. The marketing authorization application for SHR8028 (cyclosporine ophthalmic solution) eye drops for the treatment of the signs and symptoms of dry eye disease was accepted by NMPA and approval is expected later in 2024. The marketing authorization application is based on a multi-center, randomized, vehicle-controlled, double-blind, phase 3 clinical study (study number SHR8028-301) published in JAMA Ophthalmology in April 2023.

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 Phase 3 study (GOBI, MOJAVE), 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 eye, 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)
  • The GOBI trial also met all of its secondary endpoints, showing statistically significant improvements in both the signs and symptoms of DED associated with MGD that were studied
  • NOV03 was well tolerated with instillation site reactions below 0.5%
  • No treatment emergent adverse events (TEAEs) were reported by more than 2% of subjects in either treatment group

Results demonstrated in the GOBI trial confirm all efficacy and safety results from the previous Phase 2 SEECASE trial.

Regulatory status of NOV03

In May 2024 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.
The product is in regulatory review in China. The project is running at Hengrui under the project number SHR 8058.
In Japan SJP-0154 (NOV03) is in late-stage clinical development.

Publications

more information about the clinical trials.

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Products

Our products target key drivers of the disease and have constantly demonstrated significant improvement in sign and symptoms of dry eye in clinical trials.

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