Hi Folks,

After going through this forward, you may like to visit
http://retinaindia.blogspot.com/


This blog has a good information about the latest developments taking place to 
cure retinal diseases.

Regards

Shadab

There is enough light for one who wants to see.
Easy tips of improving English at
http://shadablucknow.blogspot.com/ 
My contributions to the press
http://shadablucknow.blogspot.com/2008/10/my-contributions-to-press.html#link 
Many posts on one page
http://shadablucknow.blogspot.com/search?updated-min=2008-01-01T00%3A00%3A00-08%3A00&updated-max=2009-01-01T00%3A00%3A00-08%3A00&max-results=47
  
----- Original Message ----- 
From: Retina India 
To: [email protected] 
Sent: Saturday, November 20, 2010 6:00 AM
Subject: {Retina India Connect} Ocuseva, a drug in clinical trial in Japan for 
Retinitis Pigmentosa


R-Tech Ueno Ltd. (Tokyo, Japan) announced it has completed a phase 2 clinical 
trial of 0.15% UF-021 isopropyl unoprostone (Ocuseva), which is under 
development as a treatment for retinitis pigmentosa (RP). The trial 
investigated the possibility of improving visual function in the central part 
of the retina with UF-021 in patients with RP.

The randomized, multicenter, comparative study examined 112 patients with RP 
that had progressed to the mid-to late-stage, defined as a visual acuity of 
less than 6/18 with a narrow visual field. Patients received placebo or 
Ocuseva, instilled one drop per time or two drops per time (at a 5 minute 
interval), twice a day in the morning and evening for 24 weeks. The primary 
efficacy endpoint was the change seen on the visual field analysis as checked 
by an instrument called the MP-1 microperimeter (Nidek, Gamagori, Japan), 
Retinal sensitivity was also studies by a regular Humphrey visual field 
analyzer (10-2), visual acuity, contrast sensitivity, and health-related 
quality of life, using a questionnaire on visual function (VFQ-25).

After 24 weeks, positive change in the retinal sensitivity of the central 2 
degree field of vision from baseline increased the most in the 
two-drops-per-time group, followed by the one drop- per-time group. The placebo 
group had the least significant increase in sensitivity. 


The change in the retinal sensitivity from the pretreatment level by 4 dB or 
more was seen as improvement in 15.2% of patients in the placebo group, 7.9% in 
the one-drop-per-time group, and 18.4% in the two-drops-per-time group, whereas 
the change was seen as aggravation in 21.2% in the placebo group, 15.8% in the 
one-drop-per-time group, and 2.6% in the two-drops-per-time group. There were a 
significantly lower number of aggravated cases in the 2-drops-per-time group, 
compared with the placebo group. The retinal sensitivity measured with the 
Humphrey perimeter showed statistically significant improvement at weeks 4 and 
8 in the two-drops-per-time group compared with the placebo group.

The main adverse effect of Ocuseva was ocular irritation, which, the company 
said, disappears several minutes after instillation.

Comments from Retina India Medical Team:
The results show promise, specifically with the advantage that it only requires 
instillation of drops, rather than a completed surgical intervention. Ocular 
irritation, which anyway lasts a few minutes, is the only adverse effect. The 
follow-up in the trial is 6 months (24 weeks), which is considered good enough 
to consider in any retinal trial. The only thing difficult to understand is the 
group that was instilled with placebo drops (meaning no medication) still 
showed improvement in about 17 of the 112 patients in the trial (15.2%). 

Retina India is in touch with the company to bring the trials into India 
through Retina India. 

------------------
Retina India Medical Team
www.retinaindia.org
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-- 
Retina India at www.retinaindia.org
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