Here are 15 takeaways from last week’s OIS@ASCRS 2018.
- Barry Cheskin of PowerVision reported on a pilot study of 27 patients who had the FluidVision accommodating intraocular lens implanted. The average objective accommodation at six months measured 2.00 diopters, he said.
- For the first time, Keranova presented preclinical results of its all-in-one cataract surgery platform. CEO and chairman Fabrice Romano reported the robotic system can perform an 80% automated cataract surgery procedure.
- IDx, a privately held artificial intelligence diagnostics company, didn’t present at OIS@ASCRS, but made its own news that day when it announced the Food and Drug Administration had granted its de novo request to market IDx-DR, an AI-based diagnostic system for the autonomous detection of diabetic retinopathy.
- Bala Ambati, MD, PhD, MBA, president and founder of iVeena Delivery Systems, reported positive pilot clinical trial results of the IVMED-10 drop-free implant to treat postoperative inflammation. IVMED-10 is a sustained-release implant placed in the lens capsule during cataract surgery. It delivers dexamethasone for two weeks.
- BlephEx, the company and the handheld device that treats blepharitis, achieved a couple of important milestones, president and CEO James Rynerson, MD, reported: (1) 3,000 devices are now in place; and (2) more than 100,000 procedures have been performed. Dr. Rynerson also referred to a clinical study that showed treatment with BlephEx increased tear breakup time by 66%.
- The VisAbility Micro-Insert system to treat presbyopia achieved J3 of 20/40 or better at two years in 100% of a small cohort of patients, Refocus Group CEO Mike Judy said. The company submitted a New Device Application (NDA) to the FDA in December 2017 and is hopeful to receive approval by year-end.
- A Phase I trial showed that Kedalion Therapeutics‘ micro-droplet delivery device, known as AcuStream, resulted in a 70% lower dose, 50% greater comfort, and 50% fewer adverse events than a conventional dropper. CEO Peter Noymer, PhD, said the company is planning a second round of funding for Phase II studies.
- Panoptes Pharma is developing novel small-molecule drugs to treat dry eye and uveitis, CEO Franz Obermayr, PhD, said. The company expects to file a US Investigational New Drug (IND) application this year for a Phase Ia/IIa study in dry eye, and has an ongoing Phase Ib/IIa study in uveitis
- Kala Pharmaceuticals reported positive top-line results from two Phase III trials of its lead candidate, KPI-121 0.25%, in dry eye. The first Phase III trial, STRIDE 1, showed a significant 15-day reduction in ocular discomfort severity score, and a positive trend was seen in STRIDE 2, chairman and CEO Mark Iwicki said. “We’re looking forward to discussions with the FDA,” he added.
- Oyster Point Pharma president and CEO Jeffrey Nau, PhD, disclosed Phase IIa trial results of candidate OC-01 for the treatment of dry eye. Eighteen patients showed an increase in their Schirmer test (tear production) scores. A Phase IIb trial of 118 patients is now underway, Dr. Nau said.
- With FDA approval of Rhopressa (netarsudil 0.02%) now in hand, Aerie Pharmaceuticals‘ COO and president Tom Mitro laid out what’s next. Product launch is set in May, a number of key hires have been made in the executive suite, and more than 150 sales representatives are set to hit the field.
- Nicox is poised to file an IND for NCX-470 in the third quarter this year and to start a Phase II trial immediately with 12-month readout due in 2019, chair and CEO Michele Garufi, PharmD, said. NCX-470 is a nitric-oxide-donating bimatoprost prostaglandin analog for the reduction of intraocular pressure. The company also expects to file an IND in 2019 for NCX 4251, a directed fluticasone treatment for blepharitis, and is working to open a development office in Research Triangle Park, NC, Dr. Garufi added.
- Carl Zeiss Meditec reported a significant milestone: 1 million SMILE (small-incision lenticule extraction) laser vision correction procedures have been performed worldwide, said Dirk Muehlhoff, VP of the refractive laser business unit. The US SMILE trial for myopia with astigmatism was completed in 2017. The FDA recently accepted CZM’s Premarket Approval (PMA) for review, Muehlhoff said.
- Allergan officially launched TrueTear at ASCRS. It’s a handheld neurostimulation device developed to temporarily increase tear production. The device with disposable tips is inserted into the nasal cavity to induce the production of natural tears. “We are excited to add this drug-free, drop-free treatment option for adult patients with inadequate tear production to our current portfolio,” said Jag Dosanjh, senior VP, US eye care.
- Making her first appearance at OIS as president and CEO of EyePoint Pharmaceuticals (formerly pSivida), Nancy Lurker disclosed the company aims to file an NDA in 2019 for nine-month Durasert for uveitis – and also has a glaucoma venture with an unnamed firm. While Lurker was speaking at OIS, EyePoint got word that the US Patent and Trademark Office had cleared two patents for Dexycu, the dropless, single-dose corticosteroid suspension for treatment of postoperative pain. The company had acquired the product from Icon Bioscience.
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