Hi Sol,
While there may be huge commercial benefit (and share price gain) to the company if OPT302 was able to gain market entry as a mono-therapy the greater patient benefit would seem to be generated from the synergetic effect of a combination therapy. If I was a patient I know what I'd be opting for even at this early stage.
Bioshares has provided yet another update on Opthea as a result of the trial results and Megan Baldwin's presentation at their conference in the weekend which explained the results a bit more fully. Opthea going by previous experience will release the full article in due course but I have paraphrased some key points below for other post readers:
In a comparable trial Lucentis achieved a 5.9 letter improvement in visual acuity at three months. In the OPT302 trial four treatment naïve patients who received OPT-302 plus Lucentis the average improvement in visual acuity was 16.5 letters. This was in only four patients but the implied benefit is 10.6 letters. This will obviously need to be supported with larger patient trial data but it is an encouraging result. Previously in 10 patients who had failed previous treatment with VEGF inhibitors the vision gain was 4.0 letters when treated with OPT- 302 and Lucentis. (one patient died in the trial from an existing cancer related condition and did not complete treatment.) This is a meaningful result given the improvement of just under 5.9 letter visual gain achieved with Lucentis in a Phase III study in treatment naive patients. Comparison with Fovista the leading combination therapy drug in development is Fovista from Ophthotech Corporation. Ophthotech listed in 2013 at a market value of US$662 million on the back of its Phase II trial results in 449 patients. That trial showed that after three months of therapy Fovista plus Lucentis achieved a visual gain of 8.7 letters compared to 5.1 letters with Lucentis alone (a 3.6 letter gain). Opthea achieved an average gain of 16.5 letters in the four naïve patients. One needs to consider the group in the current trial was very small and one patient in this group achieved a very high result (in the lower dose group). In the two patients of the four in the higher dose, a lower improvement in visual gain of 9.5 letters was achieved.
The appeal of Opthea is that it is working in market that is valued at over US$10 billion that is served by only two existing compounds, branded as Lucentis (and Avastin) and Eylea. Also appealing is that there are only eight other clinical programs in development in this field that are working on novel targets according to Opthea CEO Megan Baldwin.
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