Simbrinza (brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL) has been approved by the European Commission to decrease elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma (OAG) or ocular hypertension, for which monotherapy provides insufficient IOP reduction, developer Alcon (Fort Worth, Texas) said in a news release.

The twice-daily formulation is the only fixed combination glaucoma treatment without a beta blocker, Alcon noted. The safety and efficacy of Simbrinza is based on two pivotal 6-month phase 3 studies that enrolled a total of 1,450 patients with OAG or ocular hypertension who were insufficiently controlled on monotherapy or were already using multiple IOP-lowering medications.

The results of these two studies will be presented at the 32nd Congress of the European Society of Cataract & Refractive Surgeons (ESCRS) in London and during the ESCRS Glaucoma Day program next month.

Eylea approved for DME

The Food and Drug Administration has granted approval to Eylea (aflibercept, Regeneron Pharmaceuticals, Tarrytown, N.Y.) for the treatment of diabetic macular edema (DME). The recommended dosage of Eylea in patients with DME is 2 mg every 2 months (8 weeks) after 5 initial monthly injections.

The approval of Eylea for DME was based on the 1-year data from the phase 3 VISTA-DME and VIVID-DME studies of 862 patients, which compared Eylea 2 mg given monthly, Eylea 2 mg given every 2 months (after 5 initial monthly injections), or macular laser photocoagulation (at baseline and then as needed). In both studies, patients in the Eylea groups gained about 2 additional lines compared to "almost no change" in the control group. 

TrueVision granted fundamental patent

TrueVision 3D Surgical (Santa Barbara, Calif.) has been issued a patent in the U.S. for "fundamental technology underlying computer-guided methods for limbal and corneal relaxing (LRI/AK) incisions for astigmatism correcting procedures," the company said. The patent "broadly discloses and claims real-time multidimensional visualizations of target surgical fields with adjustable, positionally accurate, real-time, virtual surgical reference indicia that are automatically positioned to compensate for motion during the procedure."

According to the company, the Computer Guided Surgery invention uses preoperative data and imaging to calculate optimal incision locations to achieve specific targeted refractive outcomes for individual patients. In addition, the guidance system has the ability to integrate with surgical microscopes and/or the rapidly growing use of cataract and corneal surgical lasers, as well as display the surgical field of view in 3D and 2D simultaneously.

Iluvien receives Norwegian
marketing authorization

Iluvien (fluocinolone acetonide, 190 micrograms) has received marketing authorization from the Norwegian Medicines Evaluation Board for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies, developer Alimera Sciences (Atlanta) said in a news release.

Iluvien has been approved for reimbursement in Portugal as well; Alimera plans to launch Iluvien there in late 2014.

Ozurdex granted positive opinion in EU

The European Union's Committee for Medicinal Products for Human Use has recommended Ozurdex (dexamethasone 700 mcg intravitreal implant in applicator) to treat adult patients with vision loss due to diabetic macular edema (DME) who are pseudophakic or who are considered insufficiently responsive to or unsuitable for non-corticosteroid therapy, marketer Allergan (Irvine, Calif.) said in a news release.

The final decision is expected in the next few months, Allergan said.

Rhopressa p3 study to start in Canada

Health Canada has granted approval to Aerie Pharmaceuticals (Bedminster, N.J.) to conduct a phase 3 registration trial of Rhopressa, a novel once-daily, triple-action eye drop being tested for its ability to lower IOP in patients with glaucoma or ocular hypertension in Canada. The study, "Rocket 3," is designed to evaluate safety and tolerability of Rhopressa in patients with a follow-up of 12 months; Rocket 1 and Rocket 2 are underway in the U.S. to evaluate non-inferiority of IOP lowering of Rhopressa compared to timolol.

Total enrollment for the phase 3 studies is expected to be around 1,300 patients. Rhopressa has been shown in earlier studies to inhibit both Rho kinase and norepinephrine transporter.

Alphaeon buys PRN

Alphaeon Corporation (Irvine, Calif.) has acquired Physician Recommended Nutriceuticals (PRN, Plymouth Meeting, Pa.), a leading developer of specialty omega-3s and related products for dry eye and macular degeneration, Alphaeon said in a news release.

The transaction is worth about $55 million.

RESEARCH BRIEFS

• Rebamipide 2% ophthalmic suspension was effective in treating keratoconjunctivitis sicca (KCS) in patients with Sjögren's syndrome (SS), probably by increasing mucins and suppressing inflammatory cytokines, a group of Japanese researchers asserts. A. Arimoto and colleagues evaluated 27 patients with SS, diagnosed based on the presence of autoantibodies and/or focus score >1 on lip biopsies, with corneal fluorescein staining scores (FSS) >3, and conjunctival lissamine green staining scores (LSS) >3. The patients were treated 4 times daily for 4 weeks; assessments occurred at weeks 2 and 4. Hyaluronate and/or artificial tears were not discontinued. The patients were interviewed regarding the 5 major KCS symptoms-foreign body sensation, dry eye sensation, photophobia, ocular pain, and blurred vision-with each graded from none (0) to very severe (4). FSS and LSS showed improvement at week 2, but tear film break-up time (BUT) showed improvement at week 4. All 5 patient-reported symptoms improved significantly. When the patients were divided into 3 groups according to the presence of punctal occlusions, FSS and LSS were found to improve in all groups, but BUT improved only in patients with both puncta occluded at week 4. The study is published in Cornea.
• A group of researchers has found "low to moderate quality of evidence" that nonsteroidal anti-inflammatory drugs (NSAIDs) are more effective than steroids in controlling inflammation and preventing pseudophakic cystoid macular edema (PCME) after uncomplicated cataract surgery. L. Kessel and colleagues added they found "high-quality evidence that topical NSAIDs are more effective than topical steroids in preventing PCME." The group conducted a literature search in relevant databases to identify randomized trials published from 1996 onward comparing topical steroids with topical NSAIDs in controlling inflammation and preventing PCME in patients undergoing phacoemulsification with posterior chamber intraocular lens implantation for age-related cataract. After identifying 15 such studies, overall results found the prevalence of PCME was significantly higher in the steroid group than in the NSAID group: 3.8% versus 25.3% of patients, risk ratio 5.35 (95% confidence interval, 2.94-9.76). There was no statistically significant difference in the number of adverse events in the 2 treatment groups. The study is published online ahead of print in Ophthalmology.
• A study of 263 male patients (mean age: 69 years old) from the Miami Veterans Affairs Medical Center eye clinic found weak correlations between higher levels of androstenedione and healthier global, lipid and aqueous tear film parameters. The study, published online ahead of print in Investigative Ophthalmology & Visual Science, had patients complete the Dry Eye Questionnaire 5, undergo tear film evaluation, and measure serum androgen levels. According to P.M. Azcarate and colleagues, eyes with high dry eye study scores had higher levels of sex hormone-binding globulin (p=0.03) and lower levels of dehydroepiandrosterone sulfate (p=0.02), androstenedione (p=0.02), and androstane-3α,17β-diol glucuronide (p=0.03) compared to eyes with intermediate (0.05-0.95) or low (0-0.05) scores. There were no strong correlations between tear film measures and androgen levels. A weak inverse correlation was found between corneal staining and androstenedione, and between tear break-up time and androstenedione. When considering aqueous and lipid deficiency independently, the association between tear break-up time and androstenedione only existed with aqueous tear deficiency.