Allergan reiterates opposition to Valeant offer 

The Board of Directors of Allergan (Irvine, Calif.) has "unanimously determined" that the offer from Valeant (Laval, Quebec) to acquire all outstanding common shares is "grossly inadequate, substantially undervalues the Company, creates significant risks and uncertainties for Allergan stockholders, and is not in the best interests of the Company and its stockholders," Allergan said in a news release. The board is strongly recommending its stockholders not tender any Allergan shares
to Valeant.

Tecnis Symfony granted CE mark

The Tecnis Symfony Extended Range of Vision IOL (Abbott Medical Optics, AMO, Santa Ana, Calif.) for the treatment of cataract patients who may also have presbyopia has received the CE mark in Europe, AMO
officials said.

The Tecnis Symfony is a "first-of-its kind lens that is intended to provide patients a continuous range of vision including far, intermediate and near distances with reduced incidence of halo and glare comparable to a monofocal lens," AMO officials said.

The lens is not available in the U.S.

A combination Rho kinase (ROCK)/norepinephrine transporter (NET) inhibitor in conjunction with latanoprost was able to lower mean diurnal intraocular pressure (IOP) on day 29 from 25.1 mmHg at baseline to 16.5 mmHg, a 34% decrease in IOP, in a phase 2b study on 297 patients.

Once-daily, quadruple-action Roclatan (a combination of triple-action Rhopressa and latanoprost) showed statistically significant superiority over each of its components on day 29, developer Aerie Pharmaceuticals (Bedminster, N.J.) said in a news release. Roclatan efficacy exceeded that of latanoprost by 1.6 to 3.2 mmHg across each time point evaluated during the study (8 a.m., 10 a.m., 4 p.m. on days 8, 15, and 29). These results were statistically significant at all time points with p-values less than 0.05.

Rhopressa, a ROCK/NET inhibitor, specifically targets the trabecular meshwork and has been shown to lower episcleral venous pressure as well, Aerie said.

A phase 2b study on Rhopressa found it capable of consistent mean IOP-lowering effect irrespective of the baseline IOPs of the patients entered into the trial.

Plans are underway to move Roclatan into phase 3 studies.

Kala starts two loteprednol/MPP studies

Two clinical trials evaluating the nanotechnology-based loteprednol etabonate MPP (LE-MPP) are now underway, developer Kala Pharmaceuticals (Waltham, Mass.) said in a news release.

KPI-121-C-001 (a phase 3 study) will investigate the efficacy and safety of 1% LE-MPP dosed two times daily and 0.25% LE-MPP dosed four times daily as compared to placebo in subjects who have undergone cataract surgery and who require treatment of postoperative anterior ocular inflammation. The company expects to enroll 375 patients in 25 centers across the U.S.

KPI-121-C-002 (a phase 2 study) will investigate the safety and efficacy of 0.25% LE-MPP compared to vehicle dosed four times daily in subjects who have a documented clinical diagnosis of dry eye disease. Kala aims to enroll approximately 150 patients in up to 10 centers in the U.S.

Kala is planning additional studies on LE-MPP for treatment of posterior blepharitis and for treatment of diabetic macular edema or retinal
vein occlusion. 

Annual costs of eye diseases could reach $717 billion by 2050

The Future of Vision: Forecasting the Prevalence and Costs of Vision Problems predicts more than $384 billion in 2032 and $717 billion in 2050 in nominal costs related to eye disease and vision problems, according to Prevent Blindness (Chicago).

Among the alarming projections: costs related to eye disease are projected to increase 376% by 2050; Hispanics are projected to exhibit extremely high growth in diabetic retinopathy (DR), glaucoma, and cataract cases; women will continue to outnumber men in prevalence of all eye disease and vision loss categories except for DR; and those aged 90 and older are projected to be by far the fastest growing population segment, with their population more than tripling due to both the aging Baby Boomers and increasing longevity.

RESEARCH BRIEFS

• Compared with patients undergoing cataract surgery, there are many similarities in the demographics and refractive outcomes to patients undergoing refractive lens exchange surgery (RLE), according to O. Westin and colleagues. They evaluated an RLE cohort from a private eye clinic (n=675) and a cataract cohort from the outcome registration of the Swedish National Cataract Register. The RLE patients were younger (52.1±7.7 versus 73.84±9.32 years) with a smaller percentage of women (45.28% versus 60.46%; P<0.001) and were more often myopic than the cataract patients. The absolute biometry prediction was more accurate in RLE, particularly in patients given a customized toric IOL. In cataracts, the Haigis' formula showed higher accuracy than the SRK/T formula. The study is published online ahead of print in Acta Ophthalmologica.
• In subjects with ocular hypertension (OHT), brimonidine treatment for 6 weeks significantly reduces seated IOP during the day by increasing uveoscleral outflow, according to a study published in the Journal of Glaucoma. The lack of IOP effect at night can be explained by failure to overcome a normal nighttime reduction of uveoscleral outflow, study authors S. Fan et al. noted. Thirty participants with OHT (58.6±1.7 years old) were enrolled in the randomized, double-masked, crossover study. When treated with placebo, nighttime supine episcleral venous pressure was higher (P<0.05) compared with daytime seated episcleral venous pressure, and aqueous flow and uveoscleral flow were significantly reduced at night. Brimonidine significantly lowered seated IOP at 9:00 a.m. and 11:00 a.m., 9:00 p.m. and 11:00 p.m. and supine IOP at 9:00 a.m. and 11:00 a.m. Brimonidine increased uveoscleral outflow at 9 a.m. and 11 a.m. (P<0.01) and had no effect on daytime and nighttime aqueous flow, outflow facility, or episcleral venous pressure.
• Phacovitrectomy seems to be significantly less costly to Medicare than a sequential approach to surgery for patients with an indication for vitrectomy and a visually significant cataract, M. Seider and colleagues found. They evaluated and compared the cost of the two procedures by combining the surgeon, ambulatory surgical center, and anesthesiology fees as reimbursed by Medicare. Phacovitrectomy afforded a 17% to 20% per-patient cost savings to Medicare (depending on the type of vitrectomy) compared with vitrectomy with sequential phacoemulsification. The study is published in Retina.