EW Weekly, October 4, 2019

Enrollment completed in Phase 2 trial of NCX 4251 for blepharitis
Enrollment in a Phase 2 trial to evaluate the safety and tolerability of NCX 4251 (Nicox) in acute exacerbations of blepharitis is complete, according to a company press release. The trial's primary objective is to select the dose(s) of NCX 4251 to advance to a larger Phase 2b clinical trial. The company is planning to report topline data by the end of this year. NCX 4251 is a patented ophthalmic suspension of fluticasone propionate nanocrystals that the company believes is the first product candidate developed as a targeted topical treatment of the eyelid margin for patients with acute exacerbations of blepharitis.

First patients dosed in Phase 3 clinical trial of DEXTENZA for allergic conjunctivitis
The first patients have been dosed in a Phase 3 clinical trial of DEXTENZA (dexamethasone ophthalmic insert 0.4 mg, Ocular Therapeutix) to treat the symptoms of allergic conjunctivitis, according to a company press release. The multicenter, 1:1 randomized, double-masked, placebo-controlled trial will enroll an estimated 80 patients. Its primary objective is to evaluate the safety and efficacy of the implant versus a placebo vehicle punctal plug using the Ophthalmic Research Associates modified Conjunctival Allergen Challenge Model to treat ocular itching associated with allergic conjunctivitis. The trial will use a series of successive allergen challenges over a 30-day period. If this Phase 3 clinical trial in allergic conjunctivitis is successful, the company plans to submit a supplemental New Drug Application to the U.S. FDA for ocular itching associated with allergic conjunctivitis. Topline trial data are anticipated in the first half of next year, according to the company.

J-code in effect for OMIDRIA
According to an Omeros announcement, a permanent J-code has been assigned for OMIDRIA (phenylephrine 1%  and ketorolac intraocular solution 0.3%, Omeros). The J-code is J1097 and replaces the previous temporary C-code C9447. OMIDRIA is indicated for use during cataract surgery to prevent miosis and lower postop pain.

Bausch + Lomb, Tatvum Research enter licensing agreement for new enVista IOL designs
Bausch + Lomb has entered into a licensing agreement with the IOL development and design company Tatvum Research, according to a Bausch press release. The agreement will give Bausch + Lomb worldwide commercial rights to new IOL designs for enVista IOLs that address astigmatism and presbyopia. The new IOLs will be developed in partnership by the two companies.

Ocugen, Histogenics complete merger; Ocugen announces strategic partnership
Ocugen has completed its merger of Histogenics Corporation and has changed the combined company's name to Ocugen, Inc., according to a company press release. Ocugen also announced a strategic partnership with CanSino Biologics for Ocugen's gene therapy pipeline product candidates for inherited retinal disease, currently in development with Schepens Eye Research Institute of Massachusetts Eye and Ear. The partnership will provide developmental and clinical supplies for the development of Ocugen's OCU400, the first gene therapy product candidate in its modifier gene therapy platform.

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
  • Prediction error must be considered during bag-in-the-lens IOL power calculation in children, reported Lyubomyr Lytvynchuk, MD, PhD, and coresearchers. Their retrospective, nonrandomized, consecutive case series included 87 eyes of 56 pediatric patients who were diagnosed with cataract and operated with bag-in-the-lens IOL implantation. Age groups included Group 1 (0–3 months), Group 2 (3 to just under 12 months), Group 3 (12–36 months), and Group 4 (older than 36 months–17 years). Prediction error was defined as the absolute difference between the preop selected target and postop achieved refraction. Impact of age at surgery, axial length, keratometry, and corneal astigmatism were considered. The mean and median prediction errors for the entire group were 1.79 D and 1.23 D, respectively. The mean prediction error was 3.43 D in Group 1, 2.14 D in Group 2, 1.60 D in Group 3, and 1.33 D in Group 4. The mean prediction error in eyes with axial lengths shorter than 20 mm was 2.67 D and 1.44 D in eyes with an axial length of 20 mm or longer. The research appears in the Journal of Cataract &; Refractive Surgery.
  • A subpopulation of healthy young adults has non-pathologically thin corneas that are below 500 µm. Hannah Rashdan and coresearchers found thinner corneas more frequently in females. Their research included 168 eyes from 84 patients ages 19 to 38 years who were scanned with OCT. Corneal thickness was measured along the central 6 mm of the cornea, and total central corneal thickness, corneal epithelial thickness, and corneal stromal thickness were compared between males and females. The average central corneal thickness for males and females was 540.5 µm and 525.2 µm, respectively. Thirty-eight eyes had corneal thickness measurements below 500 µm. All women with corneas below 500 µm were bilaterally thin. Corneal thinning did not appear to be associated with age, use of systemic hormones, or degree of myopia. Accurate corneal thickness measurements are important before keratorefractive surgery and when evaluating IOP in glaucoma, the researchers concluded. The study appears in Clinical Ophthalmology.
  • The use of a universal artificial intelligence (AI) platform for a multilevel collaborative management of cataracts was robust and effective, reported Xiaohang Wu and coresearchers. The platform was used for capture mode recognition (area under the curve), cataract diagnosis (normal lens, cataract or postop eye with area under the curves), and detection of referable cataracts. It performed well in all areas. For instance, the area under the curves for detection of referable cataracts was greater than 91% in all tests. In a real-world tertiary referral pattern, the platform suggested that 30.3% of people be referred, which substantially increased the ophthalmologist-to-population service ratio by 10.2-fold compared with the traditional pattern. Researchers will extend the context of the AI-based medical referral pattern to other common disease conditions and resource-intensive situations. The study appears in the British Journal of Ophthalmology.

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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