The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a unanimous positive opinion for Omidria (phenylephrine and ketorolac injection) 1%/0.3%, to maintain mydriasis, prevent miosis, and reduce postoperative eye pain during IOL replacement procedures and cataract surgery, developer Omeros (Seattle) said in a news release.

A compound comprised of viral-like nanoparticles that demonstrate highly selective targeting of solid tumors while leaving normal epithelium untouched has been granted orphan drug designation for the treatment of uveal melanoma (also known as ocular melanoma) in the United States, said developer Aura Biosciences (Cambridge, Mass.).

AU-011 is a first-in-class drug conjugated with a potent cell-killing laser-activated molecule that is delivered "efficiently and selectively to cancerous cells, thereby reducing or eliminating the risk of non-specific activity and undesirable toxicity. The molecule is activated by a standard ophthalmologic laser and treatment will be administered in an outpatient visit," Aura said in a news release.

An oral medication for the treatment of diabetic macular edema (DME) is "extremely safe with no drug related serious adverse events," according to the OptimEyes study, which was designed to assess safety and efficacy of Optina (ultra-low dose of danazol).

Developer Ampio Pharmaceuticals (Englewood, Colo.) said danazol is "an established, synthetic derivative of modified testosterone ethisterone that affects vascular endothelial cell linkage in a biphasic manner."

An advanced imaging study found that gene therapy for Leber congenital amaurosis (LCA) improves vision, but the area of improvement declines with time, according to Samuel G. Jacobson, MD, and colleagues in the National Eye Institute-funded study. LCA is caused by an altered form of the RPE65 gene; 15 people who had been treated with gene therapy for the condition were able to regain lost vision with 4 participants relying on an area of the retina near the gene therapy injection site to identify letters.

Perry Rosenthal, MD, Boston Eye Pain Foundation and David Borsook, MD, Harvard Medical School, have proposed a "fundamentally new theory" behind dry eye. The new theory also "identifies a previously unidentified suicide-provoking, eye-centered pain disease" that the authors call oculofacial pain.

Conventional theories suggest that while tear levels may be sufficient, tears evaporate too quickly because of secretions produced by the meibomian glands. Yet other published theories discard the notion that there is a relationship between meibomian glands and dry eye.

Drs. Rosenthal and Borsook theorize that unidentified diseases of the corneal nerves increase the sensitivity of their specialized tear thickness sensors causing these eyes to feel dry despite the presence of adequate tears, and label these symptoms "false dry eye alarms." In reality, they suggest, the progression of the corneal nerve disorder eventually degrades the ability to efficiently transmit the messages for more tears to the tear glands, resulting in fewer tears.

RESEARCH BRIEFS

• Trabeculectomy and tube insertion are cost effective compared with medical treatment alone, according to Richard I. Kaplan, MD, and colleagues. Trabeculectomy, however, is cost-effective at a substantially lower cost per quality-adjusted life-years (QALYs) compared with tube insertion. The group used a Markov cohort model with a 5-year time horizon to study a hypothetical cohort of 100,000 patients who required glaucoma surgery. Costs were identified from Medicare Current Procedural Terminology and Ambulatory Payment Classification reimbursement codes and Red Book medication costs. The QALYs were based on visual field and visual acuity outcomes. The hypothetical societal limit to resources was included using a willingness-to-pay threshold of $50,000 per QALY. The mean costs for medical treatment, trabeculectomy, and tube insertion were $6,172, $7,872 and $10,075, respectively. The utility gained after each treatment option was about the same (from 3.10-3.38 QALYs). The cost effectiveness of each surgical procedure was most sensitive to early and late surgical failure rates and was minimally affected by adverse events, rates of visual field progression, or medication costs. The study is published in JAMA Ophthalmology.
• Oral supplementation with omega-3 fatty acids (FAs) significantly improved contrast sensitivity (CS) under both photopic and mesopic testing conditions in patients with moderate meibomian gland dysfunction (MGD), according to a study published in Cornea. C. Malhotra and colleagues prospectively studied 60 patients with moderate MGD who received warm compresses, lid massage, and artificial tear substitutes. The treatment group (n=30) also received oral supplements of 1.2 g omega-3 FAs daily. At the end of 12 weeks, significant improvement in CS was seen in the treatment group in 7 of the 8 testing conditions (3, 6, 12, and 18 cpd photopic and 6, 12, and 18 cpd mesopic), whereas in the placebo group, significant improvement was seen only in 3 of the 8 testing conditions (3 cpd photopic, 6 and 18 cpd mesopic). Ocular Surface Disease Index, tear break-up time, ocular surface staining, and meibum quality and expressibility improved significantly in both groups, but more so in the treatment group. Schirmer scores showed no significant improvement in either group.
• Prediction of astigmatic outcomes with toric IOLs can be improved with appropriate measuring devices and methods to establish the required toric IOL power, according to Adi Abulafia, MD, and colleagues. In this retrospective study, the authors measured postop corneal astigmatism with 3 devices and compared with the manifest astigmatic refractive outcome in patients with toric IOLs. The centroid errors in predicted residual astigmatism were against-the-rule with the Alcon and Holladay toric calculators (0.53 to 0.56 D), were lower with the Baylor nomogram (0.21 to 0.26 D), and were lowest for the Barrett toric calculator (0.01 to 0.16 D) (P<.001). The Barrett toric calculator had the lowest median absolute error in predicted residual astigmatism compared with the Alcon and Holladay toric calculators with or without the Baylor nomogram (P<.021). The Barrett toric calculator and the optical low-coherence reflectometry LENSTAR-LS 900 achieved the most accurate results; 75.0% and 97.1% of eyes were within ±0.50 D and ±0.75 D of the predicted residual astigmatism, respectively. The study is published in the Journal of Cataract & Refractive Surgery.

NEW PRODUCT BRIEFS

• Nidek (Gamagori, Japan) launched the HandyRef-K/HandyRef, portable solutions for "accurate refraction and keratometry measurements anytime and anywhere." The full graphic 3.5-inch color LCD is 40% larger than the previous model. Clear screen design and intuitive icons provide high user-friendliness. Measurements start when the alignment starts and locks in the data when alignment becomes optimal as a measurement value. Measurement data for 50 patients (100 eyes) can be saved in the main body memory.