CXL Ophthalmics, Inc., a clinical-stage company developing a minimally-invasive treatment for keratoconus, announced it has raised a $32 million Series A funding round led by AXA IM Alts through its Global Health Private Equity strategy plus a syndicate of individual investors, including leading cornea specialists. The new investments will support the advancement of CXL Ophthalmics’ (CXLO) transformative cross-linking system, EpiSmart®, through Phase 3 trials on the way to a New Drug Application with FDA.
“A safer treatment that does not disrupt the epithelium could enable treatment upon diagnosis and vision preservation for a broader group of patients. The EpiSmart trial will enroll patients upon diagnosis with tomographic imaging, which can detect keratoconus at its earliest stages”
“EpiSmart has the potential to be a game-changer for the treatment for keratoconus. With a true epithelium-preserving (Epi-On) approach, CXLO is striving to deliver safer and more accessible care globally to the millions of patients at risk of vision loss. This funding announcement is an important step in achieving this goal,” said Michael D. Webb, President and Chief Executive Officer of CXL Ophthalmics.
EpiSmart is CXLO’s transformative cross-linking system targeting keratoconus, a common type of corneal ectasia. EpiSmart is designed to be highly effective and minimally invasive with reduced discomfort, plus a decreased recovery time versus the current standard of care. CXLO’s approach will elevate the standard of care for keratoconus by enabling the treatment of both eyes simultaneously and eliminating the need for further deterioration.
“A safer treatment that does not disrupt the epithelium could enable treatment upon diagnosis and vision preservation for a broader group of patients. The EpiSmart trial will enroll patients upon diagnosis with tomographic imaging, which can detect keratoconus at its earliest stages,” said Michael W. Belin, CXLO’s Chief Medical Officer.
Curt LaBelle, MD, MBA, Head of Healthcare Private Equity at AXA IM Alts, said, “Keratoconus is undertreated globally. The current standard of care, Epi-Off cross-linking, can be painful and require months of recovery, limiting its utilization. CXLO’s Epi-On approach has the potential to safely deliver vision-preserving treatment to millions of patients globally, including resource-limited areas where Epi-Off treatment would be untenable due to the risk of infection and inadequate access to follow up care.”
Results of CXLO’s recent Phase 2 trial, the largest study to-date of corneal cross-linking as a treatment for keratoconus, indicate improvements in visual acuity after EpiSmart treatment at levels similar to currently available treatments, but with a substantial enhancement in safety and comfort compared to the current standard of care.
Piper Sandler acted as exclusive financial advisor to CXLO in connection with this capital raise.
About EpiSmart
The patented EpiSmart system, including Ribostat, is designed to optimize cross-linking therapy for keratoconus, allowing minimally-invasive treatment via simultaneous bilateral application of UV light without the need for surgical disruption of the corneal epithelium. The safety and efficacy of EpiSmart was investigated in a recently concluded 2,258-subject Phase 2 trial, and CXL Ophthalmics is preparing to initiate Phase 3 clinical trials for the treatment of keratoconus with EpiSmart.
About Keratoconus
Keratoconus is a bilateral, progressive corneal degenerative disease accompanied by corneal distortion and corneal thinning. In later stages, the cornea takes on a bulging, conical shape, leading to irregular astigmatism that is difficult or impossible to correct and results in loss of functional vision. Typical onset of symptoms occurs in late teens to early twenties but can manifest in children younger than 10 years old. Based on global epidemiological research, estimates of prevalence range from 1.2% in Australia to 4-5% in the Middle East to 8% in Africa, with geographic and ethnic variation. The recent Raine study, performed in Australia, showed a prevalence at 1.2%, which implies prevalence in the US of more than 3 million.
About AXA IM Alts
AXA IM Alts is a global leader in alternative investments with c. €188 billion of assets under management[1] comprising c.€88 billion of primarily private real estate, over €88 billion of private debt and alternative credit, as well as over €11 billion in Infrastructure, private equity and hedge funds. We take a 360° approach to real assets (real estate & infrastructure) investing with over €131 billion of assets under management in direct opportunities, held indirectly through debt and listed equities and via long term private equity investments into operating platforms. ESG is fully integrated into our investment decision making processes with our responsible investment approach anchored by the three key pillars of decarbonisation, resilience and building tomorrow. AXA IM Alts employs over 800 people located in 16 offices around the world and serves the needs of more than 500 clients from Europe, North America, Asia Pacific and Middle East. We are the number one property portfolio and asset manager in Europe[2], and one of the largest worldwide.
1 Source: AXA IM – Real Assets data (unaudited) as of 30 June 2022.
2 Source: IPE Top 150 Real Estate Investment Managers, November/December 2021. #1 real estate investment manager in Europe based on total European real estate assets under management.
About CXL Ophthalmics
CXLO is developing a minimally-invasive treatment for ectatic corneal disease that can bring early intervention to millions of patients globally. Our EpiSmart approach is a transformative cross-linking system designed to treat keratoconus without disrupting the epithelium, allowing for a rapid return to normal activities.
For more information, please visit www.cxlophthalmics.com.
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