Pershing Square, Allergan update

Pershing Square Capital Management (which, along with Laval, Quebec-based Valeant Pharmaceuticals, is launching a hostile takeover of Irvine, Calif.-based Allergan) has suggested six "highly experienced, independent directors" for the Board of Directors of Allergan, Pershing Square said in a news release. The nominated members are predominantly venture capitalists or from the non-profit sector. Pershing Square is seeking a special meeting of Allergan shareholders whereby the shareholders can accept the nominations and remove six incumbent board members.

Allergan, meanwhile, "will shelve unpromising pipeline drugs and overhaul management incentives," according to news reports. A broad restructuring plan will be unveiled during Allergan's second quarter earnings announcement planned for later this month.

Optimis Fusion granted 510(k) clearance

The Optimis Fusion integrated laser platform (Quantel Medical, Clermont-Ferrand, France) has been granted regulatory approval in the U.S., the company noted. The Optimis Fusion system combines advanced selective laser trabeculoplasty photoregeneration therapy and traditional YAG photodisruption treatments, Quantel said. 

InSite Vision to submit blepharitis treatment to FDA

InSite Vision (Alameda, Calif.) will submit a New Drug Application to the Food and Drug Administration for DexaSite (dexamethasone 0.1% in DuraSite) as a treatment for blepharitis in adults during 2015, following completion of remaining chemistry and manufacturing work, InSite said in a press release.

In its landmark phase 3 DOUBle study, DexaSite achieved superiority versus vehicle (P=0.0053) at day 15 (following 14 days of twice-daily dosing) in the clinical symptom of irritation, which was singularly judged and reported by the patient. Another independent instrument employed in this study, the Health Related Quality of Life Questionnaire, which is a patient reported outcome instrument, supported the irritation results outcome, InSite noted.

InSite plans to file the same indication in Europe during the third quarter. 

RGN-259 to enter phase 3 dry eye study
in Asia

RGN-259 (a thymosin beta 4-based preservative-free eye drop) will start a phase 3 clinical trial in patients with moderate to severe dry eye in South Korea, followed by Japan and Australia, with follow-on registrations in certain additional Asian and Pacific Rim countries, developer RegeneRx Pharmaceuticals (Rockville, Md.) said in a news release.

The proposed trial is based on data generated in a phase 2, 72-patient, double-masked, placebo-controlled trial, as well as data generated in a recently completed 9-patient physician-sponsored, double-masked, placebo-controlled phase 2 clinical trial in patients with severe dry eye syndrome, both conducted in the U.S. Both trials resulted in statistically significant sign and symptom improvements in central cornea staining and ocular discomfort.

Nicox to buy Aciex Therapeutics

Nicox (Sophia Antipolis, France) will buy Aciex Therapeutics (Boston), a privately held ophthalmic development pharmaceutical company concentrating on developing ocular allergy and inflammation products, Nicox said in a news release.

Nicox is planning a cash-free, debt-free reverse triangular merger, with an upfront payment of $65 million in the form of Nicox shares.

GOP presidential contender Rand Paul to join medical mission

GOP presidential candidate Rand Paul, MD, will join the University of Utah's John A. Moran Eye Center on a medical mission to Guatemala after Congress adjourns in August, the university said in a news release. The trip came together with help from ASCRS and is in part funded by the ASCRS Foundation. Sen. Paul was the keynote speaker at the 2014 ASCRS*ASOA Symposium & Congress in Boston.

RESEARCH BRIEFS

• Comparable complications may be expected in infants with polymethyl methacrylate (PMMA) and hydrophobic acrylic lenses, according to a new study. J. Ram and colleagues evaluated complication rates following implantation of hydrophobic acrylic vs. PMMA IOLs in infants undergoing cataract surgery. One hundred and thirteen eyes of 113 children (75 males) with mean age of 6.49±3.56 months were included. Group A included 62 eyes, and group B included 51 eyes. The two groups did not differ significantly in terms of age and axial length. There was no significant difference between the groups for incidence of posterior capsular opacification (PCO), pupillary membranes, glaucoma, fibrin on IOL surface, or IOL malposition. Development of PCO was delayed in group A (p=0.049). Thirteen eyes of group A and 18 eyes of group B required additional surgical intervention in the follow-up visits. The study is published online in Graefe's Archive for Clinical and Experimental Ophthalmology.
• The visual and refractive outcomes were good and highly stable after a toric implantable collamer lens was used, indicating this toric pIOL model is predictable, safe, and effective in correcting low and high levels of astigmatism, according to J.F. Alfonso and colleagues. After implantation of the TV4b toric Implantable Collamer Lens pIOL, the researchers evaluated the uncorrected (UDVA) and corrected (CDVA) distance visual acuities, refraction, toric pIOL vault, and adverse effects over 12 months in 35 eyes of 20 patients. At study enrollment, the patients had a mean sphere of -5.46±4.17 D and mean cylinder of -3.14±1.19 D. At 12 months, the mean sphere was -0.04±0.16 D, with 97% of eyes being within ±0.50 D of target. For the astigmatism components, 80% of eyes were within ±0.25 D of both J0 and J45. The mean decimal UDVA was 0.89±0.16 and the mean decimal CDVA, 0.95±0.12. No eye lost lines of CDVA, and 43% of eyes gained 1 or more lines. The study is published in the Journal of Cataract & Refractive Surgery.
• There are notable differences in systemic pharmacokinetics and pharmacodynamics among anti-vascular endothelial growth factor (VEGF) treatments after intravitreal administration, according to Robert Avery, MD. In his evaluation of 56 patients with wet age-related macular degeneration who received intravitreal ranibizumab (0.5 mg), bevacizumab (1.25 mg), or aflibercept (2.0 mg), systemic exposure to aflibercept was 5-, 37-, and 9-fold higher than ranibizumab, whereas bevacizumab was 9-, 310-, and 35-fold higher than ranibizumab, based on geometric mean ratio of peak and trough concentrations and area under the curve, respectively. The third dose showed accumulation of bevacizumab and aflibercept but not ranibizumab. Aflibercept substantially suppressed plasma free VEGF, with mean levels below lower limit of quantitation (10 pg/mL) as early as 3 h post-dose until ≥7 days post-dose. The study is published in the British Journal
  of Ophthalmology.

• Topcon Medical Systems (Oakland, N.J.) introduced a wireless review station that can be used with the TRC-NW300 and TRC-NW8 non-mydriatic capture systems running IMAGEnet 5. This device allows reviewing of images from an IMAGEnet 5 capture station via Wi-Fi up to a distance of 30 ft.

• BioSyntrx (Colorado Springs, Colo.) has renamed its Macula Complete line of nutritional supplements to Eye & Body Complete "so that both the eyecare professional and their patients better understand the multiple benefits of this formulation," the
  company said.