FDA approves teprotumumab-trbw for thyroid eye disease

The U.S. FDA approved TEPEZZA (teprotumumab-trbw, Horizon Therapeutics) for the treatment of thyroid eye disease. TEPEZZA, the first FDA-approved drug for thyroid eye disease, is a fully human monoclonal antibody and a targeted inhibitor of the insulin-like growth factor-1 receptor, the company reported. It is given to patients once every 3 weeks, for eight total infusions. TEPEZZA is expected to be available in the U.S. in the next few weeks. The company also announced publication of the drug’s Phase 3 OPTIC clinical trial in The New England Journal of Medicine. The trial showed significant improvements in proptosis and diplopia compared to placebo, according to the company’s press release.

First patient enrolled in Phase 3 trial for allergic conjunctivitis

The first patient has been enrolled in INVIGORATE, a Phase 3 trial for topical ocular reproxalap (Aldeyra Therapeutics), which is geared toward the treatment of allergic conjunctivitis. The randomized, double-masked, crossover vehicle-controlled trial will enroll an estimated 120 patients and focus on the safety of reproxalap compared with vehicle in an allergen chamber. The primary endpoint will be subject-reported ocular itching score. Reproxalap is a small-molecule, immune-modulating covalent inhibitor of reactive aldehyde species, according to Aldeyra.

Enrollment complete for Phase 3 trial for KPI-121 0.25% for dry eye

Enrollment is complete for the Short Term Relief in Dry Eye (STRIDE) Phase 3 trial for KPI-121 0.25% (Kala Pharmaceuticals), according to a company press release. The multicenter, randomized, double-masked, placebo-controlled, parallel-arm study compares KPI-121 0.25% to placebo in about 900 patients with dry eye disease. Both KPI-121 and placebo are dosed four times daily for 2 weeks. Those meeting initial screening and inclusion/exclusion criteria will have a 2-week run-in period with vehicle, and subjects who continue to meet inclusion/exclusion criteria after the run-in will be randomized for KPI-121 or vehicle for 2 weeks. Top-line results are expected in the first quarter of this year. Kala officials anticipate resubmitting a New Drug Application to the U.S. FDA in the first half of this year. Kala’s therapeutics use proprietary AMPPLIFY mucus-penetrating particle (MPP) drug delivery technology. If approved, the drug will be commercialized under the brand name EYSUVIS.

Wireless retinal device for AMD blindness implanted in U.S. for the first time

The PRIMA Vision System (Pixum Vision), designed to restore sight in patients who are blind from age-related macular degeneration (AMD), has been implanted in a patient for the first time in the U.S. The device was implanted in a patient at UPMC Eye Center, Pittsburgh, Pennsylvania, according to a news release. PRIMA is a 2×2 mm, 30-µm thick miniature wireless photovoltaic chip that is placed under the retina and works in tandem with augmented reality glasses that have a miniature camera and infrared projector. The chip is made up of 378 electrodes that convert infrared light from the glasses to electrical signals carried to the optic nerve. Compared with earlier-generation implants, PRIMA is wireless and has significantly more electrodes, allowing for the transmission of more visual information, according to the news release. The trial with PRIMA at UPMC is parallel to a first-in-human trial in France, which includes five patients with advanced AMD. Results in France have shown that most patients can identify letter sequences.

Design for second pivotal clinical trial of Zimura for GA announced

The design for the second pivotal trial of Zimura (avacincaptad pegol, IVERIC bio) has been announced by the company. Zimura is a complement C5 inhibitor targeted to treat geographic atrophy secondary to dry AMD. The international, multicenter, double-masked, sham-controlled trial will include about 400 patients who will be randomized to receive monthly doses of Zimura 2 mg or sham in the first year. The mean rate of change in geographic atrophy growth over 12 months will be the prespecified primary endpoint. At month 12, the company will again randomize patients in the Zimura 2 mg arm to receive monthly or bimonthly administration of Zimura 2 mg, with a final evaluation at month 24. In trial results announced last October, Zimura met its prespecified primary efficacy endpoint and reached statistical significance.

Research briefs

• Eyes implanted with the Light Adjustable Lens (LAL, RxSight) had a stable refraction, good visual acuity, and no associated pathologies, according to a nonintervention observation from Merita Schojai, MD, and coresearchers. The study included 61 patients (10 eyes) from a group of 445 patients who had cataract surgery with LAL implantation between April 2008 and December 2012. Among the 103 eyes, corrected and uncorrected distance visual acuity remained good in 93 eyes. Refractive outcomes were stable, with minimal deviation. No significant changes in corneal thickness occurred. Two patients had slight opacities of the IOL material with no impact on their visual acuity. The results are published in the Journal of Cataract & Refractive Surgery.
• In a prospective, randomized, fellow-eye controlled clinical trial, LASIK Xtra did not show any advantages over conventional femtosecond LASIK, reported Thomas Kohnen, MD, and coresearchers. Their study included 26 patients with high myopia and/or myopic astigmatism who received randomized treatment with LASIK Xtra in one eye and conventional LASIK in the fellow eye. Uncorrected distance visual acuity improved from 1.26 preop to –0.02 logMAR among LASIK Xtra eyes and from 1.27 to 0.01 logMAR in the conventional LASIK eyes. Manifest refractive spherical equivalent (MRSE) went from –7.35 D to –0.17 D in LASIK Xtra eyes and from –7.5 D to –0.25 D in conventional LASIK eyes. The only significant difference between eyes in both groups was that there was slightly better best spectacle-corrected visual acuity in conventional LASIK eyes after 1 week. There was a nonsignificant trend toward myopic regression from 3 to 12 months postop in conventional LASIK eyes. The change in MRSE was –0.15 D compared with –0.1 D in LASIK Xtra eyes. The study appears in the American Journal of Ophthalmology.
• In eyes with mild to moderate cataracts, lens thickness was independent of lens density, reported Maria Henriquez, MD, and coresearchers. Their prospective, single-center, cross-sectional study included 169 eyes with age-related mild to moderate cataracts. Lens density was measured with the Lens Opacification Classification III system, Pentacam HR Nucleus Staging software (Oculus), and ImageJ software. Nuclear color score was the only parameter with a weak significant correlation with lens thickness after researchers accounted for age, axial length, sex, and anterior chamber depth. Maximum value of average lens density and mean nuclear density were significantly correlated with lens thickness after researchers controlled for the same factors. These findings contradict what previous studies have found, according to the researchers. Central lens thickness larger than 4.48 mm was found in 54.5% of eyes with a nuclear opalescence grade I. The study appears in the British Journal of Ophthalmology.