EW Weekly, October 18, 2019

CEQUA now available in the U.S. to treat dry eye
CEQUA 0.09% (cyclosporine ophthalmic solution, Sun Ophthalmics) is now available in the U.S., according to a press release. CEQUA was previously approved by the FDA to increase tear production in patients with keratoconjunctivitis sicca.

Diplopia reduced with teprotumumab for active thyroid eye disease
Results from the Phase 3 OPTIC confirmatory clinical trial showed that teprotumumab (Horizon Therapeutics) had a significant beneficial effect on active thyroid eye disease compared with placebo. The beneficial effects included diplopia, quality of life, and clinical activity score, according to a company announcement. The results build upon data presented earlier this year, which showed the beneficial effect of the drug on proptosis. Teprotumumab is currently under Priority Review by the FDA. The Prescription Drug User Fee Act goal date is March 8, 2020.

Primary endpoint met for Phase 2b study of presbyopia drop
In a Phase 2b trial, the CSF-1 eye drop (Orasis Pharmaceuticals) met its primary endpoint, demonstrating statistically significant improvement in distance-corrected near visual acuity of a three-line or greater gain, according to a company press release. The multicenter, double-masked clinical trial focused on the efficacy and safety of CSF-1 in 166 participants evaluated at several research centers across the U.S.

Enrollment completed for pilot clinical study to treat keratoconus
Enrollment is complete in a pilot clinical study to treat keratoconus with the use of the TECLens CXLens on-eye crosslinking system for corneal remodeling, according to a TECLens press release. Clinical trial results are slated for early next year. TECLens also announced a collaboration with ophthalmic medical device manufacturer SERVimed Industrial Spa to develop a new combination product for keratoconus. The product will combine the CXLens crosslinking system with SERVimed's trans-epithelial RIBOCROSS riboflavin drug formulation. The two companies plan to pursue U.S. FDA approval for the combination product. RIBOCROSS has an FDA orphan drug designation for the treatment of keratoconus.

Enrollment completed in international SPECTRUM registry for Hydrus Microstent
Enrollment is complete in the SPECTRUM registry for the Hydrus Microstent (Ivantis), according to a company press release. SPECTRUM includes nearly 3,000 eyes with 700+ standalone glaucoma procedures. The registry began in 2013 outside the U.S. and covers the broadest range of glaucoma ever studied in a single body of data for a MIGS device, the company reported. There are cases from 50 centers in 19 countries and more than 70% follow-up. Among the cohort of nearly 250 eyes followed for 3 years, the IOP was lowered by 29%, and a commensurate reduction of one medication occurred compared with preop levels. Data from SPECTRUM will be reported in 2021, with some data reported throughout 2020 at various medical conferences.

Enrollment complete in U.S. IDE trial for iStent infinite
Patient enrollment is complete in the FDA Investigational Device Exemption trial for the iStent infinite Trabecular Micro-Bypass System (Glaukos), according to a company announcement. The prospective, unmasked, multicenter, single-arm clinical trial enrolled subjects with previous unsuccessful incisional glaucoma surgery who had an IOP that was not adequately controlled with currently tolerated topical ocular hypotensive medications as well as subjects who did not have previous incisional glaucoma surgery but who used maximally tolerated topical ocular hypotensive medications with uncontrolled IOP. There were a total of 72 subjects implanted with the iStent infinite at 15 clinical sites. The primary efficacy endpoint in the trial is a mean diurnal IOP from baseline at 12 months postop on the same or fewer topical ocular hypotensive medications. The trial results will be used to seek FDA approval of iStent infinite.

Eyevance acquires TOBRADEX ST and NATACYN
Eyevance Pharmaceuticals has acquired TOBRADEX ST (tobramycin/dexamethasone ophthalmic suspension) 0.3%/0.05% and NATACYN (natamycin ophthalmic suspension) 5% from Novartis.

Allergan shareholders approve proposed AbbVie acquisition
Shareholders at Allergan have approved the proposed acquisition by AbbVie, according to an Allergan press release. AbbVie is slated to acquire Allergan in a cash and stock transaction valued at approximately $63 billion. The acquisition is slated to take place early next year.

Submit your nomination for the inaugural ASCRS Educator Award
The new ASCRS Educator Award recognizes an ASCRS member who has made education an enduring career priority. Nominees must: have demonstrated passion and commitment to education, leadership, and selflessness in the pursuit of expanding knowledge in the interest of improving patient outcomes; be an ophthalmologist focused on anterior segment surgery; have at least 5 years in practice; and be a current ASCRS member.
Nominations are due by November 29. Find more information at ascrs.org/educatoraward.

Research briefs
  • Sustained gazing, such as silent reading, has a negative impact on the visual performance in dry eye patients, reported Esen Akpek, MD, and coresearchers. Their prospective, comparative, before-and-after study included 176 patients with dry eye and 33 controls. Dry eye symptoms and clinical parameters were measured, as well as out-loud reading speed using the International Reading Speed Test (IReST) as words per minute. The reading speed was repeated using a different IReST excerpt after 30 minutes of silent reading. There were no differences in reading speed in the patients with dry eye vs. controls. Dry eye patients had a decrease in reading speed after silent reading and in an increase in the length of time to read the passage compared with baseline (161 vs. 172 words per minute and 38 vs. 33 seconds, respectively). Each 1-point increase in baseline corneal staining score (0 to 6) led to a 5 word-per-minute reduction in reading speed. The research is published in the American Journal of Ophthalmology.
  • A review of topical cyclosporine A for dry eye syndrome, Cintia de Paiva, MD, PhD, and coresearchers found that evidence on the effect of cyclosporine on ocular discomfort and ocular surface and tear film parameters, such as corneal fluorescein staining, Schirmer’s test, and tear film break-up time, is inconsistent and may not be different from vehicle or artificial tears reported in various trials. There also may be an increase in nonserious treatment-related side effects, such as burning in cyclosporine groups. The evidence they reviewed from 30 randomized clinical trials and 4,009 participants did not support that improvements in conjunctival mucus production through increased conjunctival goblet cells leads to improved symptoms or ocular surface and tear film parameters. Large clinical trials that are well planned and look at long-term data are needed to assess cyclosporine A further, the researchers concluded. The research appears in Cochrane Database of Systematic Reviews.
  • Corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA) lowered significantly after 10 years of rigid iris-fixated phakic IOL implantation, according to Soraya Jonker, MD, and coresearchers. This is a result of significant myopization caused by an increased axial length that is unrelated to the phakic IOL. Their prospective case series included 460 eyes (250 patients) with implantation of an Artisan (Ophtec) myopic or toric iris-fixated phakic IOL as of January 1998. All changes were measured annually and then reported after 1, 5, and 10 years postop. The mean myopization was –0.79 D after 10 years, with 52% of eyes within a ±1 D target. Over 10 years, the mean logMAR CDVA increase was 0.05; 95% of eyes had a CDVA of 20/40 or more, and 7% lost two or more lines of CDVA. Also over 10 years, the mean logMAR UDVA increased by 0.14. Explantation took place with 10% of phakic IOLs due to cataract formation after a mean of 97.9 months. Higher preop age and longer axial length were risk factors for shorter survival due to cataract formation. The study is published in the Journal of Cataract & Refractive Surgery.

Product News
  • The FDA has given 510(k) regulatory clearance for the launch of LEAF (Norlase), which will be Norlase’s flagship laser product to treat retina and glaucoma disease. LEAF allows laser therapy to be performed in almost any exam room.
  • Silverstone (Optos) was released at the American Academy of Ophthalmology annual meeting in San Francisco. It combines ultra-widefield imaging with integrated, image-guided, swept-source OCT.

This issue of EyeWorld Weekly was edited by Stacy Jablonski and Vanessa Caceres.

EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: Eric Donnenfeld, MD, Chief Medical Editor; Rosa Braga-Mele, MD, Cataract Editor; Clara Chan, MD, Cornea Editor; Nathan Radcliffe, MD, Glaucoma Editor; and Vance Thompson, MD, Refractive Editor

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