Clearside Biomedical predicts its uveitis drug will be rejected, after FDA requests more data
In its second-quarter update earlier this month, eye drug developer Clearside Biomedical indicated it was looking to out-license its lead drug, Xipere, which is currently under FDA review. But those plans may be put on hold after the company on Thursday disclosed the FDA has asked for more data on the drug’s marketing application.
As a result, Clearside expects to receive a Complete Response Letter from the FDA on or before the decision date of October 19, it said. The drug, Xipere (triamcinolone acetonide ophthalmic suspension), is being evaluated for the treatment of macular edema associated with uveitis, which is characterized by inflammation of the middle layer of the eye.
Agency officials have requested Clearside provide stability data on triamcinolone acetonide (TA) suspension produced, employing an ‘enhanced manufacturing process’ used by the company. Although the formulation of the TA suspension has not changed — the agency wants to verify the comparability of the stability profiles of the batches made with the enhanced manufacturing process versus the batches originally submitted as part of the marketing application, Clearside said.
George Lasezkay “We believe this is primarily a timing issue since our stability data from previously manufactured batches have been consistent and predictable, and we have every reason to believe this will continue to be the case…Discussions with potential XIPERE out-licensing partners remain ongoing,” said Clearside chief George Lasezkay. “We continue to expect that we will have sufficient resources to fund operations into the third quarter of 2020, without relying on any partnership-related payments that we might gain through XIPERE partnering or R&D collaboration agreements.”
Investors weren’t quite as optimistic. Shares of the Alpharetta, Georgia-based company $CLSD tumbled more than 38% to 78 cents before the bell on Friday.
In a note earlier this month, Needham’s Serge Belanger suggested the Xipere was poised to win FDA approval with a broad pan-uveitis label that would differentiate it from other corticosteroids, such as Allergan’s $AGN Ozurdex, Bausch Health’s Retisert and EyePoint Pharmaceuticals’ Yutiq.
“We previously pegged Xipere’s potential peak sales in uveitis at $100MM-$150MM. The out-licensing of Xipere makes sense from a corporate strategy for CLSD since the company’s current financial resources (~$26MM as of 6/30/19) limit the ability to properly invest in a product launch. Xipere’s potential is likely too small to merit its own commercial infrastructure and makes more sense in the hands of a company with an existing sales force,” he wrote.
“We view the change in strategy as the ideal scenario since it potentially enhances the commercial value of Xipere, which CLSD would have been unable to achieve with its limited financial resources (~$26MM as of 6/30/19).”
On Thursday, the company suggested the FDA’s request had no readthrough to the rest of the company’s platform, which is in the preclinical stages and is focused on gene therapy and small molecules.
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