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CXL Ophthalmics Publishes Results of EpiSmart® Cross-Linking Phase 2 Clinical Trial for Keratoconus in Cornea

Largest study to-date of corneal cross-linking to treat keratoconus

Company aims to develop leading standard of care for keratoconus and corneal ectasia

SHERBORN, Mass., September 29, 2022--(BUSINESS WIRE)--CXL Ophthalmics, Inc., a clinical-stage company developing a minimally-invasive treatment for keratoconus, today published results of the EpiSmart cross-linking Phase 2 study for keratoconus in Cornea: The Journal of Cornea and External Disease.

The Phase 2 trial is the largest study to-date of corneal cross-linking in the treatment of keratoconus, including 1,922 keratoconus patients. Results indicated improvements in best corrected visual acuity at 6 and 12 months after EpiSmart "Epi-On" treatment. Safety results suggest greater comfort during the acute healing period and fewer risks compared to the current standard of care.

"The results of this study demonstrate the promise of our approach to cross-linking in halting the progression of keratoconus in patients and restoring vision with a minimally-invasive process," said Michael D. Webb, President and Chief Executive Officer of CXL Ophthalmics. "We believe that this study is further proof of the efficacy of CXLO’s transformative cross-linking system. EpiSmart is designed to be minimally-invasive with reduced discomfort compared to current standards of care. Our elegant approach will elevate the standard of care for keratoconus by enabling the treatment of both eyes simultaneously and eliminating the need for further deterioration."

Key findings include:

  • Eighty percent of patients maintained or improved corrected distance visual acuity 12 months post-operation.

  • Eighty-nine percent of patients 21 years or younger showed stable or improved vision at 12 months.

  • Visual improvements were similar to the current standard of care treatment using an "Epi-Off" cross-linking technique, but with fewer adverse events (AEs) than Epi-Off techniques.

    • No corneal infections were reported after Epi-On cross-linking, whereas corneal infection risk is elevated during epithelial removal procedures.

    • Of those who underwent EpiSmart procedures in our Phase 2 trial 0.3% (6/2,228) developed a corneal haze or opacity, which is reported in 64% of those treated with the FDA approved Epi-Off procedure.

The Phase 2 study consisted of three treatment arms with varying UV doses. Phase 3 trials are planned to assess the safety and efficacy of the EpiSmart cross-linking over 12 months against a placebo and sham control.

Michael W. Belin, MD, Chief Medical Officer of CXL Ophthalmics added, "The current standard of care, Epi-Off cross-linking, is risky, painful, can require months of recovery and can only be performed on one eye at a time. Additionally, removal of the epithelium poses significant challenges in resource-constrained settings around the world, a troubling limitation given recent epidemiological research which estimates that keratoconus is more common globally than previously recognized. We are pleased to report that EpiSmart’s improvements in vision mirror those of Epi-Off cross-linking, but with a reported improvement in comfort and safety and a return to normal activities in 1-2 days rather than weeks."

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 a U.S. prevalence of more than 3 million.

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.

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Tara Mulloy
MacDougall Advisors
(978) 855-5219