Biotech Values

[mouton29]

There weren't any huge safety issues, but there were clearly a large number of more minor safety issues compared to eylea.

The difference is not as large as appears at first glance. For example, the largest difference was in vitreous floaters, but according to this interview with Dugel https://www.biotechtv.com/post/ocular-therapeutix-february-17-2026 at 12 minutes in, doctors were instructed to report eluting particles if observed on examination, and did so and reported them as floaters, but there was no vision impact. The cataract rate was higher at 7% but Ocular claims they weren't caused by treatment and in any event, the 7% rate is equal to that shown in the Eylea package insert, https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125387s087lbl.pdf. And the SOL-R redosing data will be a part of any FDA submission, even if they are submitting based on a single study primary endpoint, they need safety data from at least 300 treated patients and so will have to be including the SOL-R safety data of sufficient patients to get them over 300.

Had it been cleaner, and with a compelling clinical need... then sure, would have been likely to garner approval on SOL-1 alone. But this is not the case, so... .

No compelling need?

There's are lots of studies backing up the 40% discontinuation rate for anti-VEGF therapy that Dugel cites all the time. Easy enough to find. As well, fibrosis and vision loss happen over time even on optimal anti-VEGF therapy. See, for example, this 2022 Nature article at https://www.nature.com/articles/s41433-022-02153-9

Since their approval 15 years ago, anti-VEGF therapies have reduced the rates of visual impairment or blindness due to nAMD [3]. However, data from routine care has revealed that the visual gains seen at 1 and 2 years are lost over time. While this is in part due to sub-optimal management [4], progression to atrophy and/or fibrosis can occur despite optimal VEGF therapy [5, 6]. We consider below some of the reasons for such loss of vision gain.