Hemera biosciences12/23/2023 ![]() CLS-AX is an inhibitor of vascular endothelial growth factor receptor (VEGF)-1, -2 and -3 giving it broader VEGF inhibition than the current standard of care drugs aflibercept and ranibizumab. The company's lead pipeline candidate is CLS-AX, a suspension of the tyrosine kinase inhibitor (TKI) axitinib, and is currently in a Phase 1/2a dose escalation trial for the treatment of patients with wet AMD. Bausch has stated that they believe XIPERE is a $600 million dollar opportunity. Unfortunately, given the delay in NDA resubmission, Bausch amended the licensing agreement and Clearside will not receive any royalties on the first $45 million of cumulative net sales of XIPERE. Thankfully for investors, the company gained approval on and the company received $20 million in non-dilutive funding from their partners.Ĭlearside is now entitled to receive tiered royalties at increasing percentages from the high-teens to twenty percent on sales of XIPERE. Given that, there was a lot at stake for the company to achieve approval for XIPERE this time around, including milestone payments from partners Bausch + Lomb and Arctic Vision. The company additionally had multiple delays resubmitting the NDA for XIPERE citing issues with their contract manufacturing organization (CMO). XIPEREĬlearside initially received a complete response letter (CRL) from the FDA in response to the XIPERE new drug application (NDA) that sent the stock plummeting over 40% in 2019. ![]() This article will review Clearside's pipeline candidates, partnered programs, and speculate on further business development. Partner Regenxbio has seen early success with administering gene therapy candidate RGX-314 into the SCS using Clearside's microinjector, and as such the company is seeking to establish additional partnerships for ocular gene therapy programs. The company will now focus on advancing internal pipeline candidate CLS-AX for the treatment of Wet age-related macular degeneration (AMD), as well as advancing its partnered programs. XIPERE will now be marketed and sold by Bausch + Lomb ( BLCO ), the eye care business of Bausch Health Companies, with the official launch taking place in March, 2022. This approval was the first for Clearside using their SCS microinjector platform that administers therapeutics to the suprachoroidal space (SCS) via a microneedle. Natali_Mis/iStock via Getty Images IntroductionĬlearside Biomedical announced in 2021 that XIPERE (triamcinolone acetonide injectable suspension) was approved for the treatment of macular edema associated with uveitis.
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