EyePoint Pharmaceuticals has announced sweeping job cuts after its eye disease candidate, duravyu, failed to meet its key goal during a late-stage study in wet age-related macular degeneration (wAMD).
This miss stems from the Phase III LUCIA study (NCT06683742), in which EyePoint pitted duravyu against Bayer and Regeneron’s blockbuster therapy, Eylea (aflibercept), in adults with wAMD. Researcher primarily conducted LUCIA to determine whether duravyu could offer non-inferior improvements in the sharpness and clarity of recipients’ vision versus Eylea.
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During this trial, however, duravyu failed to meet this milestone, despite treated patients experiencing vision improvements and a reduction in treatment burden, as well as the period of time they remained supplement-free.
Given the endpoint miss, EyePoint has opted to terminate the medicine’s Phase III programme in this indication early – meaning the biotech will no fully complete the second year of the LUCIA and LUGANO (NCT06668064) studies. A negative readout from the LUGANO study (NCT06668064) had already come earlier this year.
By putting a stop to these studies early, EyePoint hopes to “preserve capital and maximise shareholder value”, while sharpening its focus on duravyu’s development in diabetic macular oedema (DME). Currently, the company expects topline late-stage data on duravyu in DME in the final quarter of 2027. The Phase II VREONA study (NCT06099184) in DME met its primary and secondary endpoints.
Its R&D efforts are not the only element of the business that will receive a slimdown, with EyePoint also planning to cut 53% of its workforce to save around $30m per year.
Following the LUCIA study miss, EyePoint’s stock value crashed more than 80%, going from $2.99 at market close on 16 October to $0.55 at open on 19 October.
Next steps for EyePoint
While investors appear disappointed at the LUCIA results, Jefferies analysts are now turning their eyes to duravyu’s potential in DME. In a research note, they stated that the Phase II VERONA results in DME for duravyu “looked good”, but a small sample size is currently limiting their confidence in the drug.
“DME readouts are risky given small N-size and differences in study design; VERONA was a single-injection study,” they commented.
Currently, anti-VEGF therapies are the gold standard treatment for DME, with blockbuster drugs like Eylea and Roche’s Vabysmo (faricimab) currently dominating the commercial market.
According to a recent epidemiology report from GlobalData, parent company of Clinical Trials Arena, analysts forecast that the number of DME cases across the seven major markets (7MM: The US, France, Germany, Italy, Spain, the UK and Japan) will reach 3.46 million in 2034.
