SurModics Inc (SRDX)

[aslan2772]

STRIDE data

The biggest news (IMHO) from the STRIDE trial, is that the device was well tolerated with no safety issues. To evaluate these parameters was the purpose of the trial. This is a significant finding as previous trials using IVT steroid injection have shown a high incidence of adverse side effects, notably increased IOP in as high as 40% of patients (at one year), if I remember correctly. Use of intravitreal corticosteroids generally has been reserved for cases of DME in which there is at least moderate loss of visual acuity (i.e., worse than 20/40). Steriods generally have not been widely used for mild cases of DME due to concerns about potential risks to vision, particularly glaucoma and cataract, relative to the potential benefit. Thus, the 6-month Phase I data looks very encouraging to me in that they demostrate reasonable safety and suggest I-Vation may have greatly enhanced safety relative to IVT injection (probably because IVT injection requires high doses of a given drug, in order to reduce the procedural frequency to something like a monthly dose -- high doses increase side effects dramatically for most drugs).

I think the efficacy data look better than expected for this early stage, and frankly, while it would be nice, showing good efficacy for this drug-device combination is not the ultimate goal here anyways, IMHO. Either use of I-Vation-TA as an adjunct to Lucentis to stabilize vision, or geting better drugs on the device are the real values, IMHO. That this small, preliminary data set using Triamcinolone suggests efficacy just reinforces my opinion that site-specific slow-elution drug delivery will have advantages well beyond convienence.

Dew, I think your interpretation is reasonable. I would not personally call the PR disingenous though, just not very explicit. It appears they had some measure of visual improvement that fell short of the FDA definition but still wanted to convey them to investors. Any trend towards visual improvement at 6 months for this phase-I trial is encouraging. BTW, the SRDX definition of visual improvement for the PR appears to be 1 line ("line") improvement. I would add the following note to Dew's interpretation:

In the PR, SRDX noted that 43 percent (13/30) of patients treated with I-vation TA achieved visual acuity of 20/40 or better, compared to 20 percent (6/30) at baseline. Thus, a minimum of 23% (7/30) of patients showed some measurable vision improvement, although I agree it almost certainly falls short of the FDA definition of 3 lines, or else SRDX would have reported it as such. FYI, doubling of visual acuity (eg 20/40 vs 20/80) is equivalent to 15 letters (3 lines).

Keep in mind, there is no approved treatment for enhancing vision in DME, and this is just 6-month Phase-I data. The only appproved treatment to reduce the risk of vision loss from diabetic macular edema is laser photocoagulation, which has a tendancy to produce blind spots and isn't very effective.

Unfortunately, the AARS meeting is not a public venue, and I can't seem to find more specific data on these results. Hopefully this will be forthcoming.