Perhaps the bounce back comes from the dust settling on the DME trial result and with it the market realisation on deeper analysis that nothing has fundamentally changed in relation to the corporate potential of Opthea.......well that's my personal take on the trial result.
Bioshares in their recent update (some edited notes follow) puts things into perspective when citing Opthea as an example of when it came clinical trials that they do not always yield the results which are expected, particularly when thepatient population does not have a consistent disease progression or treatment history. However, learnings from clinical studies are alwaysbeneficial and this is endorsed to some extent by Megan Baldwin's comment that the trial had advanced the company's thinking in treating patients heavily pre-treated with VEGF-A therapies in DME. The results from 115 patients showed that 52.8% treated with Opthea's drugcandidate, OPT-302, when dosed in combination with the drug Eylea, achieved more thana five letter gain in vision. However, 60% of patients treated with Eylea alone achieved afive letter improvement in vision over the three months of treatment. This is the headline from the study that I suspect has caught the eye (sorry about the pun!) of investors. The strong performance in the control arm (Eylea only) was a surprisingresult. Investigators involved in the study believe this can be explained bythe under-treatment with anti-VEGF-A therapy prior to the study (treatment every six toeight weeks with a minimum of three treatments in the preceding five months), followedby more regular treatment during the study, with monthly treatment for three months.It would appear that patients in the study who were previously treated with Lucentis, andpossibly receiving treatment every six or eight weeks have benefited from switching toEylea monthly treatment. In this study, all patients were switched to Eylea but only onemonth prior to the trial commencing.However, in a subgroup analysis in 20 patients who were previously treated with Eylea(rather than Lucentis), the benefit from adding OPT-302 was clear. In this subgroup,patients on OPT-302 plus Eylea achieved a mean 8.6 letter gain in visual acuity, comparedto just a 5.0 letter gain with Eylea alone and a strong 50% of patients receiving thecombination therapy achieved more than a 10 letter gain, compared to 0% in the Eyleacontrol group.One of the investigators in the study, Dr David Boyer, said that Eylea is currently thesafest approved therapy and that adding OPT-302 appears to deliver a significant improvement. I’m shocked how much vision, especially the three line gainers (16%) and two line gainers (50%), that we were able to get in this (sub) group,. he said. Patients will often start therapy on Lucentis (for insurance reasons) and then are movedon to Eylea, which is more capable of relieving the eye of excess fluid. However, anotherinvestigator in the study, Dr Arshad Khanani, said that once that treatment option isexhausted, there are no other current treatment options, other than steroids.
Some further comments included. In addition to a mixed treatment group of patients entering thestudy, other limitations of the study included a relatively smallpatient population (115) and the short treatment period (threemonths).Treatment considerations for future studies include a longer andlarger study, treatment of naïve patients only (those who have notreceived anti-VEGF-A therapy in the past), or a looking at longerpre-treatment period with Eylea (i.e. not just one month minimum). They finished with the comment that Opthea is clearly very much focussed on the planned upcoming trials for AMD
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