Viatris’ investigational blepharitis ointment failed to achieve the primary endpoint in its Phase III trial, prompting the company to reconsider the drug’s future.
The Phase III study (NCT06400511) evaluated the efficacy and safety of MR-139 (pimecrolimus 0.3%) ophthalmic ointment in 477 patients with the condition.
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Blepharitis usually affects both eyes along the edges of the eyelids and results from clogged oil glands at the base of the eyelashes.
The study failed to reach the primary endpoint of complete resolution of debris after six weeks of twice-daily dosing.
After the failure was announced, Viatris’ stock dropped 4.2%, from $9.27 at market close on 17 July to $8.88 at market close on 18 July. The US company has a market cap of $10.42bn.
Viatris’ chief R&D officer Philippe Martin said the company is currently working out the next steps for MR-139 in blepharitis.
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By GlobalDataMartin said: “Given that the study did not meet its objective for patients suffering from blepharitis, we are evaluating the appropriate next steps for the Phase III programme, which may include revising the planned additional Phase III study.”
A cream formulation of pimecrolimus, marketed as Eildel, was approved in 2001 for use in a number of dermatology indications by Novartis. Generics have since been approved by companies, including Teva Pharmaceuticals and Glenmark Therapeutics. The therapy has not been approved in any ophthalmology indications.
Last month, the company’s phentolamine ophthalmic solution 0.75% was successful in a second Phase III presbyopia study, with the company eyeing FDA approval of the therapy. In the same month, Viatris also had success in the Phase III LYNX-2 trial of MR-142 in keratorefractive patients experiencing visual disturbances under mesopic, low-contrast conditions.
Approved treatments for blepharitis include steroid eyedrops and topical antibiotics; however, in some circumstances, oral antibiotics may also be prescribed. For Demodex blepharitis, Tarsus Pharmaceuticals’ Xdemvy (lotilaner ophthalmic solution) is prescribed to target and eliminate the mites on the eyelashes responsible for the condition.
GlobalData predicts Xdemvy to reach blockbuster status in 2030, with a global sales forecast of $1.03bn.
GlobalData is the parent company of Clinical Trials Arena.
