Valeant ups its offer for Allergan

Earlier this week, Valeant (Laval, Canada) increased its offer to $58.30 in cash and 0.83 of a Valeant share for each share of Allergan (Irvine, Calif.) stock (totaling about $49 billion), which represented only a modest increase of its previous offer of about $45 billion.

Valeant also promised to pay up to an additional $25/share if Allergan's DARPin therapy for age-related macular degeneration met certain thresholds, and would commit up to $400 million to develop the therapy and retain those working on the treatment.

Valeant "fully expects" to merge with Allergan, chief executive officer J. Michael Pearson said, adding the company spends little time on the merger details.

Allergan filed an investor presentation with the Securities and Exchange Commission on May 27, 2014, detailing the analysis of publicly available data on Valeant and, among other things, the opaque nature of Valeant's pro-forma driven financial reporting, the company said in a press release. The presentation addresses "a number of important issues regarding the sustainability of Valeant's business model and stock value that Allergan believes are highly relevant considerations for Allergan's stockholders," the company said. 

Europe grants positive opinion for Simbrinza

The European Medicines Agency has issued a positive opinion for twice-daily Simbrinza eye drops suspension (brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL) to decrease elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension, for whom monotherapy provides insufficient IOP reduction, according to developer Novartis (Basel, Switzerland).

In two phase 3 studies, the fixed-dose combination drug reduced IOP by 23%-34% and 25%-37%, respectively. Novartis added that, if approved, Simbrinza will be the only beta blocker-free, fixed-dose combination treatment in Europe for patients contraindicated for beta blockers due to certain respiratory or cardiac conditions.

The two pivotal 6-month phase 3 studies evaluated the safety in 1,450 patients with open-angle glaucoma or ocular hypertension. The primary endpoint for both studies was an assessment of mean diurnal IOP change from baseline at 3 months, with safety and supportive efficacy evaluated through 6 months. In the first study, the mean diurnal IOP reduction at month 3 was greater for patients treated with Simbrinza (7.9 mmHg) vs. brinzolamide (6.5 mmHg) or brimonidine (6.4 mmHg). In the second study, mean diurnal IOP reduction at month 3 was similar for patients in the Simbrinza (8.5 mmHg) and concomitantly dosed brinzolamide + brimonidine (8.3 mmHg) treatment groups.

MicroPulse technology demonstrates safety, durability

A 1-year, multicenter study demonstrated sustained intraocular pressure (IOP) decrease of 20%-25% with MicroPulse Laser Trabeculoplasty, said developer Iridex (Mountain View, Calif.). At a symposium during this year's ASCRS*ASOA Symposium & Congress, Iqbal "Ike" Ahmed, MD, said the therapy should be considered a first-line treatment for glaucoma patients, "as well as patients who haven't seen significant effects from medications."

MicroPulse is a fovea-friendly tissue-sparing laser delivery therapy that works by electronically "chopping" the laser emission into trains of microsecond pulses. This allows the physician to blanket the affected tissue with laser energy while allowing the tissue to cool between pulses, offering the potential for ocular treatment with less collateral effects than conventional laser treatments.

Two newly published studies found a sizable number of patients do not regularly use the eye drops prescribed to them for their glaucoma, and that topical medications for glaucoma lower intraocular pressure and can delay or slow the progression of the eye disease, JAMA Ophthalmology said in a news release.

Of the 407 patients who completed the 3-month adherence assessment in the first study, 337 (82.8%) took their medication correctly on at least 75% of days. The other 70 patients (17.2%) (deemed nonadherent) were less likely to be able to name their glaucoma medication, less likely to agree that remembering to use the medication was easy, and more likely to agree with the sentiment that eye drops can cause problems, according to Michael V. Boland, MD, and colleagues.

The group's second study assessed medication adherence in the original 70 noncompliant patients, who were then randomized to an intervention (n=38) or to a control group (n=32) where they received no additional intervention. The intervention consisted of daily messages, either text or voice, reminding patients to use their glaucoma medication. A personal health record was used to store lists of patient medications and reminder preferences.

The median adherence rate in the 38 patients in the intervention increased from 53% to 64%. There was no change in the control group. Patients in the intervention (84%) agreed the reminders were helpful and that they would continue to use them outside the study. Implementing the intervention is estimated to cost about $20 per year per patient.

Eye Foundation of America launches international program

For ophthalmology students who have an interest in diabetic retinopathy, the Eye Foundation of America (Morgantown, W.Va.) and the Goutami Eye Institute (Rajahmundry, India) have jointly announced a hands-on program where students will perform in-the-field diabetic retinopathy preventative screenings as well as hospital-based experience at the Goutami Eye Institute, a teaching hospital about 300 miles east of Hyderabad.

The program is being made available to ophthalmology students who are in their third year of residency or in a fellowship program. Participation can range from 1-4 weeks, the groups said.

RESEARCH BRIEFS

• In the Collaborative Initial Glaucoma Treatment Study (CIGTS), substantial visual field (VF) loss and improvement were comparable through 5 years of follow-up, after which VF loss became more frequent, according to D.C. Musch and colleagues. The group identified 607 subjects with newly diagnosed open angle glaucoma to compare the efficacy of trabeculectomy and topical medications. The percentage of participants showing substantial VF improvement over time was similar to that showing VF loss through 5 years after initial treatment, after which VF loss became more frequent. Measures of better intraocular pressure (IOP) control during treatment were significantly predictive of VF improvement, including a lower mean IOP, a lower minimum IOP, and lower sustained levels of IOP over follow-up. The study is published online ahead of print in the American Journal of Ophthalmology.
• Unfavorable visual outcomes in children with open globe injuries were related to a younger age at presentation, poor presenting visual acuity, injuries caused by blunt or missile objects, posterior wound location, hyphema, vitreous hemorrhage, and surgical intervention of pars plana vitrectomy, according to X. Liu and colleagues. They retrospectively evaluated 140 eyes of 137 consecutive open globe injury patients, who were treated at the Eye Center of Second Bethune Hospital affiliated with Jilin University (Changchun, China) between August 2005 and August 2012. Of the 137 patients, there were 116 (84.7%) boys and 21 (15.3%) girls. Their ages ranged between 3 and 17 years old. Only three (2.2%) children suffered bilateral eye injury. Living utensils, industrial tools, and fireworks contributed to the most common causes of open globe injury. Eighty-one (59.1%) had sharp force injuries, 23 (16.8%) had blunt injuries, and 33 (24.1%) had missile injuries. The study is published online ahead of print in Eye.
• Toric IOL implantation was comparable to astigmatic keratotomy (AK) in eyes with moderate astigmatism having phacoemulsification, according to a new study. J.S. Titiyal and colleagues prospectively enrolled and randomized 34 eyes (34 patients) to temporal clear corneal 2.75 mm phacoemulsification with toric IOL implantation (toric IOL group) or to 30-degree coupled AK at the 7.0 mm optic zone (AK group). There was no difference in UDVA or CDVA between the 2 groups at any follow-up visit, no statistical differences in mean preop and postop refractive cylinder between the two groups, no statistical differences in the mean residual astigmatism at 3 months, and no statistical differences in the number of eyes achieving a residual refractive cylinder of 1.00 D or less. The study is published in the Journal of Cataract & Refractive Surgery.