LianBio Partner Tarsus Pharmaceuticals Announces U.S. FDA Approval of XDEMVY™ (lotilaner ophthalmic solution) 0.25% for the Treatment of Demodex Blepharitis

Rhea-AI Summary

Tarsus Pharmaceuticals received FDA approval for XDEMVY™ (lotlilaner ophthalmic solution) 0.25% to treat Demodex blepharitis, marking the first FDA-approved treatment targeting Demodex mites. LianBio, the partner of Tarsus, is conducting a Phase 3 trial in China and expects to report results in Q4 2023.

SHANGHAI, China and PRINCETON, N.J., July 26, 2023 (GLOBE NEWSWIRE) -- LianBio’s (Nasdaq: LIAN) partner, Tarsus Pharmaceuticals (Tarsus), announced yesterday that the U.S. Food and Drug Administration (FDA) approved XDEMVY™ (lotlilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis. XDEMVY, formerly known as TP-03, is the first and only FDA approved treatment to directly target Demodex mites, the root cause of Demodex blepharitis.

LianBio in-licensed rights from Tarsus for the development and commercialization of TP-03 for Demodex blepharitis and Meibomian Gland Disease in Mainland China, Hong Kong, Macau and Taiwan. LianBio is currently conducting the LIBRA trial, a Phase 3 multicenter, double-blind, randomized, vehicle-controlled registrational study designed to evaluate the efficacy and safety of TP-03 in Chinese adult patients with Demodex blepharitis, with an open-label pharmacokinetics sub-study. LIBRA completed enrollment of 163 patients in June 2023. The co-primary endpoints are complete collarette cure (collarette score of 0) and mite eradication (mite density of 0 mites per lash) at day 43. Secondary endpoints include composite cure of collarette and erythema (collarette score of 0 and erythema score of 0) at day 43. LianBio expects to report topline results from LIBRA in the fourth quarter of 2023. More information about the LIBRA trial can be found on http://www.chinadrugtrials.org.cn/index.html (CTR20220726) and http://www.clinicaltrials.gov (NCT05629390).

"We congratulate Tarsus on receiving U.S. FDA approval of XDEMVY for the treatment of Demodex blepharitis,” said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. “XDEMVY is the only approved drug in the United States that targets the root cause of Demodex blepharitis, a disease that impacts an estimated 43 million patients in China. We look forward to concluding our LIBRA study this year, and if the data are positive, submitting a New Drug Application to support regulatory approval in China.”

About Demodex Blepharitis
Blepharitis is a common lid margin disease that is characterized by eyelid margin inflammation, redness and ocular irritation which not only causes ocular discomfort but can have an adverse effect on quality of life. Demodex blepharitis is caused by an infestation of Demodex mites, the most common ectoparasite found on humans which accounts for over two-thirds of all blepharitis cases. Demodex blepharitis may affect as many as 40 million people in China.

About XDEMVY™
XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, is a novel prescription eye drop designed to treat Demodex blepharitis by targeting and eradicating the root cause of the disease – Demodex mite infestation. The active ingredient in XDEMVY is lotilaner, which is a well-characterized agent that eradicates Demodex mites by selectively inhibiting the mite’s GABA-Cl channels. It is a highly lipophilic molecule, which may promote its uptake in the oily sebum of the eye lash follicles where the mites reside. XDEMVY was evaluated in two pivotal trials conducted by Tarsus Pharmaceuticals in the United States collectively involving more than 800 patients. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found the XDEMVY eye drop to be neutral to very comfortable. The most common ocular adverse reactions observed in the studies were instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported by less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis.

About LianBio
LianBio is a cross-border biotechnology company on a mission to bring transformative medicines to historically underserved patients in China and other Asian markets. Through partnerships with highly innovative biopharmaceutical companies around the world, LianBio is advancing a diversified portfolio of clinically validated product candidates with the potential to drive new standards of care across cardiovascular, oncology, ophthalmology, and inflammatory disease indications. LianBio is establishing an international infrastructure to position the company as a partner of choice with a platform to provide access to China and other Asian markets. For more information, please visit www.lianbio.com.

Cautionary Note Regarding Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements. The words “estimate,” “potential,” “expect,” “may,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include, but are not limited to, statements concerning the potential of TP-03 to target the root cause of Demodex blepharitis, the Company’s plans and expectations with respect to its ability to develop and bring XDEMVY to patients in China, the potential for the LIBRA trial to support registration of XDEMVY in China, and the Company’s plans and expectations with respect to the timing of reporting topline results from the LIBRA clinical trial of XDEMVY in China. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the Company’s ability to successfully conduct its planned clinical trials and complete such clinical trials and obtain results on its expected timelines, or at all; competition from other biotechnology and pharmaceutical companies; general market conditions; the impact of changing laws and regulations and those risks and uncertainties described in LianBio’s filings with the U.S. Securities and Exchange Commission (SEC), including LianBio’s Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and LianBio specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon this information as current or accurate after its publication date.

For investor inquiries, please contact:

Elizabeth Anderson, VP Communications and Investor Relations
E: elizabeth.anderson@lianbio.com
T: +1 646 655 8390

For media inquiries, please contact:
Josh Xu, Director of Communications
E: josh.xu@lianbio.com
T: +86 136 6140 8315

Katherine Smith, Evoke Canale  
E: katherine.smith@evokegroup.com
T: +1 619 849 5378

FAQ

What is the FDA approval for Tarsus Pharmaceuticals?

The FDA approved XDEMVY™ (lotlilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis, the first FDA-approved treatment targeting Demodex mites.

What is LianBio's role in the development of XDEMVY™?

LianBio in-licensed rights from Tarsus for the development and commercialization of TP-03 for Demodex blepharitis and Meibomian Gland Disease in Mainland China, Hong Kong, Macau, and Taiwan.

What is the status of the LIBRA trial?

The LIBRA trial is a Phase 3 study in China evaluating the efficacy and safety of TP-03 in Chinese adult patients with Demodex blepharitis. It completed enrollment of 163 patients in June 2023 and expects to report topline results in Q4 2023.