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Clearside Biomedical Clears Hurdle For Late-Stage Eye Disease Study


  • Clearside Biomedical reports positive phase 3 results in patients with macular edema associated with non-infectious uveitis.
  • Suprachoroidal CLS-TA beat out placebo in best corrected visual acuity observed in 47% of patients versus 16% for the placebo group.
  • Another catalyst for the macular edema program would be the upcoming medical presentation with results, in addition to the the NDA filing in Q4 2018.
  • Positive results for the initial indication in macular edema should bode well for the other two programs of retinal vein occlusion and diabetic macular edema.
  • The financials need to be spruced up slightly, therefore I expect dilution to occur in the coming months.

On Monday, Clearside Biomedical (NASDAQ:CLSD) announced positive results for its late-stage study treating patients with macular edema associated with non-infectious uveitis. The company noted that the trial had met both the primary and secondary endpoints of the study. Besides the positive results, it is worth noting that this study in itself was a huge breakthrough. That reason being because it was the first pivotal phase 3 study for uveitic macular edema in which Best Corrected Visual Acuity (BCVA) was used as the primary endpoint. Clearside's suprachoroidal CLS-TA passed the primary endpoint with flying colors.

Phase 3 Data

The phase 3 trial was known as PEACHTREE, and it recruited a total of 160 patients. These were patients who had macular edema associated with non-infectious uveitis. The primary endpoint was looking for a proportion of patients that would achieve a change from baseline for at least 15 letters in best corrected visual acuity for a 24-week period using a scale known as ETDRS. That's exactly what happened. It was shown that treatment with suprachoroidal CLS-TA was able to beat out placebo by a huge margin. It was shown that at least 47% of patients that were treated with suprachoroidal CLS-TA were able to see at a minimum 15 letters. This compares to the placebo group which only had 16% of patients observe that many letters in the same time period. Thus, the reason why the stock traded higher by as much as 53% in pre-market trading. In my opinion, these results demonstrate efficacy for the company's suprachoroidal CLS-TA treatment. That is a good thing, because Clearside is also testing the same form of treatment in two other eye diseases. These are diabetic macular edema and retinal vein occlusion. With the mechanism of action proven, there is a high probability that the other studies could also come out positive as well.

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This article was written by

Terry Chrisomalis profile picture

I am the Founder of Biotech Analysis Central, A subscription service on Seeking Alpha's Marketplace. If you want to learn more about biotech investing or you want to check out my biotech analysis you can do so with a free 2-week trial to my service. Just hit the "Learn More" button on the bottom of the Marketplace Research Tab. I have a Bachelors of Applied Science Degree In Technology Management, Industrial and Business Services Management from St. Petersburg College Florida. I have been investing in biotech stocks for many years, and I prefer to invest as a long term investor. With that In mind I seek stocks that have long term value! I primarily Like to Invest In biotechnology stocks and I accept the risks. I Write for the Healthcare Sector and Stock market in general. I contribute to Seeking Alpha.

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Comments (8)

Terry, what is the market potential of this drug? You can be glamorous in your writings, but as an investor this is most important. You have not address this question. Thanks
Moonfever profile picture
more like raise at $13, yikes. haha think she's going drop hard possibly.
WEll there's something fishy about this trial. These should be patients with the worst kind of chronic uveitis? Normally all these patients have to be treated with a dolop of steroids for flares every now and again... whatever the background treatment. From that they get IOP spikes. But in this trial the "sham" arm - and sham means the bolus steroid would always be given anyway cos they get flares. Except here! There were zero IOP events!! ... the ae is usually a 2mm rise. "Through 24 weeks, corticosteroid-related elevated intraocular pressure adverse events were reported for approximately 11.5% of patients in the CLS-TA treatment group, compared to no patients in the sham group."
So does this mean that the study group was not that bad.... change in bcva was good though...
How is this better than PSDV which already filed NDA and is waiting acceptance and eventual approval. CLSD is way overvalued compared to PSDV. Not a buy in my opinion, PSDV a better bet with 3 approved products and forth on the way.
IlliniJ profile picture
Apparently the market does not agree based on market cap - PSDV $52mm to CLSD $328mm.
IcebergsInc profile picture
Good summary and I agree they will likely use this opportunity to raise money around the $7 mark
Terry Chrisomalis profile picture
yes all biotechs go through dilution, but it is just a temporary headwind. If the company has something good on its hands, like Clearside does then it will trade higher regardless.
Sir, what is the market potential of this drug? No one addresses this. I am thinking about buying tomorrow if it dips. I am eagerly awaiting your response.
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