Positive top-line results from a phase 2 investigator-sponsored study of Medidur for posterior, intermediate, and pan-uveitis include a statistically significant reduction in recurrence of uveitis and a statistically significant improvement in visual acuity in eyes treated with the fluocinolone acetonide implant, developer pSivida (Watertown, Mass.) said in a press release.

In the 3-year, ongoing study, 11 participants with recurrent non-infectious intermediate, posterior, or pan-uveitis were randomized to receive a masked low or a high dose of Medidur. Fellow eyes with uveitis were treated with standard of care, which included steroid eye drops. Participants have been followed for between 12 and 24 months.

Through the last follow-up visit reported, none of the eyes treated with Medidur had any recurrence of uveitis, while fellow eyes treated with standard of care averaged 2.33 recurrences (p=0.014). Further, the Medidur-treated eyes gained an average of 17 letters from baseline letters at 12 months on the Snellen eye chart (p=0.014 at 12 months). At the last follow-up visit reported, the average gain from baseline in Medidur-treated eyes was more than 20 letters, while eyes treated with standard of care declined an average of 10 letters.

Positive final results from a phase 2 investigator-sponsored clinical trial of OHR-102 (0.2% squalamine lactate ophthalmic solution) in patients with macular edema secondary to branch (BRVO) and central retinal vein occlusion (CRVO) have been reported, developer Ohr Pharmaceutical (New York) said.

In the phase 2 study, following an initial 10-week combination therapy treatment period, patients who continued to receive a combination of topical OHR-102 BID plus ranibizumab (Lucentis, Genentech, South San Francisco, Calif.) achieved greater visual acuity (VA) gains than the control group who received ranibizumab alone. At week 38, the mean gain in VA from baseline for patients randomized (at week 10) to treatment with OHR-102 + Lucentis PRN was +27.8 letters compared with +23.3 for patients randomized to treatment with Lucentis plus PRN alone (control group), a clinically meaningful difference of +4.5 letters.

RESEARCH BRIEFS

• The risk factors for late in-the-bag IOL dislocation cannot be explained by the growing pseudophakic population only, according to a group of researchers who also estimated the incidence of this condition over a 21-year period. Kinga Dabrowska-Kloda, MD, and colleagues retrospectively evaluated 123 eyes that had in-the-bag IOL dislocation occurring between 1992 and 2012. The annual incidence varied between 0.00% and 0.08%. The cumulative risk 5, 10, 15, and 20 years after cataract extraction was 0.09%, 0.55%, 1.00%, and 1.00%, respectively, and was significantly higher (P < .001) in eyes that had cataract surgery between 2002 and 2012 than in those operated on between 1992 and 2001 (0.89% versus 0.39% at 10 years postoperatively) (P < .001). Calendar time (date) of dislocation was positively correlated with the duration of preceding pseudophakia (P=.005). Phacoemulsification time was longer in eyes with dislocation than in control eyes (P<.001). Other identified risk factors were pseudoexfoliation, zonular dehiscence, pseudophacodonesis, and increased axial length. The study is published online ahead of print in Journal of Cataract & Refractive Surgery.
• Phacoemulsification surgery may aggravate the signs and symptoms of dry eye and affect dry eye test values in chronic dry eye patients in short-term, but not in the long-term, according to S. Cetinkaya and colleagues. They enrolled 192 eyes of 96 patients (30 males, 66 females) with chronic dry eye syndrome and cataract, who had undergone phacoemulsification surgery. Ocular Surface Disease Index (OSDI) questionnaire scores increased postoperatively but arrived at preoperative levels at the end of the 3rd month following the surgery. Fluorescein staining patterns according to Oxford Schema got worse postoperatively, however after postoperative 3rd month they got better and resembled preoperative patterns. The mean postoperative Day 1, Week 1, and Month 1 break-up time (BUT) values were significantly lower than preoperative BUT value, however 3rd month, 6th month, 1st year, and 2nd year values were not significantly different from preoperative value. Similarly, the mean postop Schirmer test scores were statistically significantly lower initially but returned to comparative preop levels by month 3. The study is published in BMC Ophthalmology.
• Conventional and accelerated corneal collagen cross-linking (CXL) are effective in stabilizing keratoconus progression after a mean of 12 months, according to a comparative interventional study. A.L. Ng and colleagues evaluated consecutive patients with progressive keratoconus who underwent either conventional (3 mW/cm2 irradiance for 30 minutes) or accelerated CXL (9 mW/cm2 irradiance for 10 minutes). There were a total of 26 eyes with an average follow up of 13.9±6.3 months. Fourteen eyes received conventional CXL and 12 eyes had accelerated CXL. In the conventional CXL group, corrected distance visual acuity (CDVA) improved significantly (p=0.021). There was also a significant reduction in Kmax and Kmean. In the accelerated CXL group, no significant changes were found in CDVA (p=0.395), Kmax (p=0.388) and Kmean (p=0.952) postoperatively. A significantly greater reduction in Kmax and Kmean were seen in conventional CXL compared to its accelerated counterpart (p=0.001 and 0.015, respectively). The demarcation line was deeper in eyes with conventional CXL and the depth correlated significantly with the change in Kmean. The study is published in Clinical and Experimental Ophthalmology.

NEW PRODUCT BRIEFS

• Santen (Osaka, Japan) has launched Ikervis (ciclosporin) for treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes, in Germany. Ikervis will be launched sequentially in Europe. Ikervis is the first drug in Europe for the treatment of severe keratitis in adult patients with dry eye disease.
• Santen has also launched Taptiqom preservative-free fixed combination eye drops (tafluprost 15 mg/ml and timolol 5mg/ml), in the U.K. Taptiqom is indicated for the reduction of intraocular pressure in adult patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical monotherapy with beta-blockers or prostaglandin analogues and require a combination therapy and who would benefit from preservative-free eye drops.