Valeant takes Allergan offer directly
to stockholders

Earlier this week, Valeant Pharmaceuticals (Laval, Quebec) took its stock exchange proposal directly to Allergan shareholders. Under the terms of the offer, Allergan stockholders would be able to elect to exchange each of their Allergan shares for $72.00 in cash and 0.83 Valeant common shares, or an amount of cash, or a number of Valeant common shares, in each case subject to proration, according to Valeant.

The offer will expire on August 15, 2014; Valeant "expects to complete a second-step merger promptly following the consummation of the exchange offer in order to acquire the remaining Allergan shares."

Meanwhile, Irvine, Calif.-based Allergan has continued to state Valeant's business model is "unsustainable," and relies "on serial acquisitions and cost reductions, as opposed to top-line revenue growth and operational excellence." The company cited several third party financial analysts who offer similar perspectives. Allergan did note, however, that its board of directors would consider Valeant's latest offer and respond in due time, noting the board reviewed the same offer by Valeant and found it "substantially undervalues Allergan, creates significant risks and uncertainties for the stockholders of Allergan, and is not in the best interests of Allergan and its stockholders."

RP drug granted orphan designation

OCU100, recombinant lens epithelium derived growth factor 1-326 (LEDGF1-326), has received orphan drug status from the U.S. Food and Drug Administration for the treatment of retinitis pigmentosa (RP), developers Ocugen (Aurora, Colo.) and the University of Colorado said in a news release.

Preclinical studies on OCU100 found the compound able to reduce protein aggregation and associated cellular stresses, both of which contribute to RP, the release said.

Phase 1 safety and tolerability studies are expected to start in 2015. 

Bayer seeks EU marketing approval for aflibercept in BRVO

Aflibercept (Eylea, Bayer HealthCare, Berlin, Germany) has been submitted to European regulators for the treatment of macular edema following branch retinal vein occlusion (BRVO), Bayer said in a
news release.

Eylea is currently marketed in Europe for the treatment of patients with neovascular age-related macular degeneration and the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion. Bayer is also seeking marketing authorization on Eylea for the treatment of diabetic macular edema.

The submission is based on the positive results from the phase 3 VIBRANT trial, which was a double-masked, randomized, active-controlled study of patients with macular edema secondary to BRVO. In the VIBRANT study, 53% of patients who received aflibercept solution for injection 2 milligram monthly gained at least 15 letters (equivalent to three lines) in best corrected visual acuity from baseline at week 24, the primary endpoint of the study, compared to 27% of patients who received laser, the current standard of care (P<0.001), Bayer said.

InSite Vision (Alameda, Calif.) and Senju Pharmaceutical Co. (Osaka, Japan) have entered into a collaboration and license agreement to develop and market InSite's azithromycin ophthalmic solution using DuraSite including AzaSite 1% and AzaSite Xtra 2% ocular antibiotics in Japan. Senju has agreed to pay InSite an upfront license fee, additional development milestone fees, and a percentage royalty on net sales.

In other news, InSite received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for Bromfenac Non-Steroidal Ophthalmic Compositions Formulated in DuraSite. The allowed patent claims contain both composition and method of treatment claims that will broadly cover all of InSite's bromfenac product candidates, including BromSite (bromfenac 0.075% ophthalmic solution formulated in DuraSite, ISV-303) for the treatment of inflammation and prevention of pain post cataract surgery, ISV-101 (bromfenac 0.01% to 0.04% ophthalmic solution formulated in DuraSite) for the treatment of dry eye disease, as well as bromfenac and dexamethasone containing products such as BromDex (ISV-504). The patent is expected to provide protection for bromfenac formulations in DuraSite to 2029.

The company plans to file a New Drug Application for BromSite later
this year. 

Parion, Santen to collaborate on dry eye drug

Parion Sciences (Durham, N.C.) and Santen (Osaka, Japan) have agreed to co-develop P-321 for dry eye disease in certain Asian territories, Parion said in a news release.

P-321 is a potent epithelial sodium channel (ENaC) inhibitor; preclinical models of dry eye disease have demonstrated that by blocking ENaC, the tear film volume is restored, maintaining its protective and lubricating actions on the ocular surface.

Last month, the U.S. Food and Drug Administration accepted the company's Investigational New Drug Application, and Parion plans to initiate a U.S. phase 1/2a clinical trial in patients suffering from dry eye disease next month.

Eye sensor could track IOP, glaucoma

University of Washington engineers have designed a low-power sensor that could be placed permanently in a person's eye to track hard-to-measure changes in eye pressure. The sensor would be embedded with an IOL during cataract surgery and would detect pressure changes instantaneously, then transmit the data wirelessly using radio frequency waves, the university said in a news release.

The researchers said the device would "one day be embedded into ... the capsular tension ring." Results from an initial study have been published in the Journal of Micromechanics and Microengineering. 

TearLab, Sjogren's Foundation promote dry eye disease awareness month

TearLab (San Diego) will raise awareness of dry eye disease through professional communications and in-clinic materials, including staff buttons, the company said. These buttons will be an important part of a social media effort; for every "selfie" taken of a staff member wearing a button, TearLab will donate $1 to the Sjogren's Syndrome Foundation. Photos can be submitted via tweet to @TearLab or email to marketingresourcegroup@tearlab.com through July 31. More information is available at www.dryeyedisease.org. 

RESEARCH BRIEFS

• Patients with obstructive sleep apnea (OSA) do not have higher odds of glaucoma compared with patients who do not have OSA, according to results from a large multicenter prospective cohort. F. Aptel and colleagues analyzed data from a French multicenter prospective cohort study including OSA-suspected patients from private practice, general and teaching hospitals. A total of 9,580 patients aged >50 years were included. Among these patients, 6,754 had sleep apnea and 330 had glaucoma. Glaucoma prevalence was 3.55% in patients with OSA and 3.14% in patients without OSA. The variables significantly influencing the odds of glaucoma with multivariate regression were age >61.4 years, body mass index <30 kg/m(2), female gender, arterial hypertension, high triglyceride levels, and thyroid dysfunction. The study is published in Sleep Medicine.
• Antibiotic prophylaxis is probably not needed when giving intravitreal injections, but a recent study published in Graefe's Archives for Clinical and Experimental Ophthalmology suggests additional data is needed to help determine the proper treatment for post-injection endophthalmitis. C.Q. Yu and C.N. Ta conducted a literature-based review on the correlation between intravitreal injections and endophthalmitis. With more than 20 relevant studies, the duo found the per-injection endophthalmitis rate is low at about 0.03% with povidone-iodine preparations, and antibiotics do not appear to be beneficial. The evaluated studies differed in recommendations for best timing of vitrectomy.
• A group of Japanese researchers has found a new method of measurement of visual acuity (VA) by use of a psychometric function is better than that of the conventional method using a decimal visual acuity chart. T. Tokutake and colleagues measured the VA of 15 healthy adults by both methods, with each subject being measured three times for each test. In both tests the standard deviations of the psychometric function were significantly lower than those of the decimal VA chart. In four of the five subjects with ocular diseases, the psychometric function was significantly improved by treatment. The study is published online ahead of print in the Japanese Journal of Ophthalmology.