Tag: Squalamine

UPDATED: Are there eye drops instead of injections to treat wet AMD?

The short answer to that question: not yet.  There is a major problem in developing eye drops for AMD.  One article states it as “Ophthalmic drugs have traditionally been administered topically, which in general provides therapeutic levels to the anterior (front) chamber of the eye but not to the posterior (back) segment. Therefore, topical administration of drugs has been largely infeasible for posterior segment diseases such as AMD and diabetic macular oedema.  In contrast, intravitreous injection [for wet AMD] provides direct delivery to the posterior segment and allows therapeutic levels to be attained.”

Here are the studies so far (there is other research that I’m not including that is currently only being done with animals).  Keep in mind that there are four phases to clinical trials.  Click here for more information about clinical trials.

  • PAN-90806/Panoptica: topical Lucentis
    • clinicaltrials.gov Phase I completed
    • “A phase I/II trial of the next generation of the formulation is set to begin in the first and second quarters of 2017.” Click here for an article.
  • OHR-102 (originally “Squalamine”): squalamine has been shown to interrupt and reverse the process of angiogenesis; used in conjunction with Lucentis injections, goal is to reduce number of injections or eliminate them.
    • clinical trials phase III not recruiting subjects,  completed in mid-2019.
    • click here for an article.
    • Temporary suspension of clinical trial phase 2, not due to safety issues.  Going forward with phase III.  “Effectiveness: Unfortunately, Squalamine Eye Drops failed to decrease the average number of Lucentis injections required by the study participants. This was the primary goal of the clinical trial and the result was disappointing, both to researchers and to people with wet AMD, who were hoping that Squalamine Eye Drops could possibly reduce, or even eliminate, the need for eye injections.”
  • CPP: cell-penetrating peptide (CPP) can be used to deliver therapeutically relevant doses of ranibizumab (Lucentis) and bevacizumab (Avastin)
    • University of Birmingham, England
    • click here for an article.
    • “This is exciting for both patients and practitioners,” said Dr. Jayanth Sridhar, assistant professor of clinical ophthalmology at the Bascom Palmer Eye Institute. “But this was a preliminary study in animal eyes only. Further research must be undertaken in human subjects first to establish safety, and then to establish effectiveness. Still, this study offers at least a glimmer of hope that in the coming years we may see a topical drop option emerge to supplement or replace injections.”
  • OC-118: “solubilizing nanoparticle” technology
    • Article Jan. 6. 2018 says “This technology, the company hopes, can boost the drug’s ability to reach the front and the back of the eye — something that previous drugs haven’t achieved unless delivered via needle to the eye.” It is currently being looked at to treat Diabetic Macular Edema (DME). I couldn’t find anything to confirm or deny that it could be used to treat AMD.

Updated & verified 1/8/2018

Maybe They Have Something

Good afternoon! It was a busy morning. My husband had to take the car for service so he dropped me off at the hospital for a shoulder x-ray and routine blood work. My shoulder pain is little better.

You would think I could just continue with up dogs, down dogs, planks, side planks and all those other yoga moves with no negative effects, but nooooo, my shoulder is really sore. It might have something to do with my not being as young as I used to be, but I doubt it.?

Then I walked down to get a haircut and Pizza Hut buffet lunch. Picked up by hubby. Grocery store. This year’s photos to the camera store for display. Home.

I have cleaning to do. I have a report to write. Oh, well. I have an OBLIGATION to our website!

At the end of last year Lin did a page on topical treatment for wet AMD. That means eye drops instead of shots. One of the ones she talked about was Squalamine. At that time Squalamine had failed to satisfy the efficacy standard laid out and the trials had been terminated.

Squalamine had failed to reduce the number of shots needed to keep crazy, blood vessel growth at bay. However, there were some secondary goals that were reached. According to the January 29, 2017 VisionAware, there were positive effects on acuity. This was especially true in people with a specific type of lesion. 31% of the people with ‘classic’ wet AMD lesions gained 11 letters on the chart!

According to healio.com a classic lesion in wet AMD has well-demarcated hyperfluorescence in the early part of the test and progressive leakage later on. It is not to be confused with occult or combined lesions.

Ohl Pharmaceuticals decided in February, 2017 to take the 200 people already enrolled and start in on phase 3 trials. In April Ohl announced it was amending the timelines of the study so there could be results late this year or early 2018. They also amended their goal to be an increase in visual acuity as opposed to a reduction in shots needed.

Now, I am wandering into the area of unsubstantiated speculation here, so don’t take what I say as gospel. OK ? OK. The April 10th press release alluded to the research being funded until early 2018. To quote: “Following the close of financing today we are funded until 2018 including completion of our ongoing clinical trial and data readout by the end of 2017 or early 2018.” Now if that were me and I were getting positive results, I would want to show off those results quickly and improve investments and other funding. If I had squat, I would stall and plead for just a little more time and MONEY.

In other words, I think they have something.

Another reason I think they have something? The press release said they were working with the patients who had “the greatest potential to benefit from Squalamine combined therapy”. In other words, they stacked the deck. (In my opinion, of course.)

Anticipating they rock the phase 3 study AND the FDA gives approval to ‘go live’ in a reasonable amount of time, a combination Squalamine/Lucentis treatment could be available in 2018. Cool. We are on our way.

Written October 9th, 2017 Continue reading “Maybe They Have Something”

UPDATED: Are there eye drops instead of injections to treat wet AMD?

The short answer to that question: not yet.  There is a major problem in developing eye drops for AMD.  One article states it as “Ophthalmic drugs have traditionally been administered topically, which in general provides therapeutic levels to the anterior (front) chamber of the eye but not to the Continue reading “UPDATED: Are there eye drops instead of injections to treat wet AMD?”

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