• The FDA approved Bausch + Lomb’s TENEO Excimer Laser Platform for LASIK vision correction surgery for myopia and myopic astigmatism. The advanced eye-tracker operates at 1,740 Hz, more than three times the speed of the laser’s repetition. This feature helps to ensure the laser ablation pattern is not negatively impacted by a patient's eye movement and to achieve outstanding postoperative outcomes. The platform’s high-speed (500 Hz) laser operates at an ablation time of approximately 1.2 seconds per diopter. Its customizable graphical user interface touchscreen allows surgeons to access the patient data they choose without flipping through screens. The TENEO software treats the manifest refraction and does not require a nomogram. The process requires three steps: select patient; choose and confirm treatment; and treat. 

• Alcon announced positive topline results from the two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512, a topical transient receptor potential melastatin 8 (TRPM8) agonist, and product candidate for the treatment of the signs and symptoms of dry eye disease (DED). In both COMET-2 and COMET-3, which enrolled more than 930 dry eye subjects in total (randomized 1:1 to AR-15512 or vehicle control), the primary endpoint of the proportion of subjects with at least a 10-mm increase in unanesthetized Schirmer’s score achieved statistical significance at Day 14 [p<0.0001]. These data are consistent with the proposed mechanism of action of AR-15512. Additional data derived from secondary endpoints demonstrated the rapid onset and sustained tear production associated with AR-15512 compared to vehicle, as early as Day 1 and persistent to Day 90. AR-15512 was well tolerated, and no serious ocular adverse events were reported.

• In filing claims last week, members of the Outpatient Ophthalmic Surgery Society (OOSS) reported cataract and some other ophthalmic facility rates were substantially understated. The OOSS stated in a letter that it checked the rate addenda released by CMS on Dec. 27 against its own calculations and that it is clear the agency utilized incorrect data in its development of rates. OOSS says it expects that these issues will be resolved by CMS and the Medicare Administrative Contractors (MACs) in the short term.
  
  “As facility owners, operators, and administrators, we have options. The first is to hold all claims until the matter is resolved. The second is to file the claims, expecting that carriers will make the appropriate adjustments. Finally, the facility can file the claims, receive payment, and then appeal the claim with supporting documentation once CMS and the contractors have corrected the problem,” the OOSS also stated in the letter. 
  
  OOSS is directing any questions to Michael Romansky, Washington Counsel (mromansky@OOSS.org) or to Albert Castillo, director of member services (acastillo@OOSS.org).

• Gentex Corp. announced the asset acquisition of eSight to develop and manufacture the next generation of its mobile electronic eyewear. eSight’s wearable assistive technology assists people living with visual impairments while performing the tasks of daily living. The comprehensive medical equipment enhances vision for individuals with over 20 distinct ocular disorders, frequently enabling users to attain 20/20 vision. eSight eyewear combines a high-definition camera, proprietary algorithms and processing platform to relay and magnify real-time imagery onto two high-resolution screens positioned before each eye. Gentex has applied its capabilities in digital vision, software development and industrial design to advance the development of eSight eyewear in a partnership that was originally announced in January 2022. 

• OKYO Pharma Limited reported positive safety and efficacy results in its Phase 2, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of OK-101 ophthalmic solution in subjects with DED. OK-101 demonstrated superiority when compared to placebo in the sign endpoint of total conjunctival staining as measured by the Ora Calibra Staining Scale as early as Day 29 (p = 0.034) as well as across at least two symptoms of DED, including burning measured by the Ora Calibra 4-symptom questionnaire as well as burning/stinging measured by a visual analogue scale as early as Day 15 (p = 0.04 and p=0.03, respectively). A statistically significant improvement in blurred vision was also achieved at Day 29 (p = 0.01). Treatment emergent adverse events (TEAEs) were observed to be similar to the placebo-treated group. No severe drug related ocular TEAEs were seen.

• Ocuphire Pharma received agreement from the FDA under a Special Protocol Assessment for the clinical trial protocol and planned statistical analysis of the LYNX-2 Phase 3 trial to evaluate phentolamine ophthalmic solution for the proposed indication to treat decreased visual acuity under dim (mesopic) light conditions. Ocuphire received written agreement from the FDA that the clinical trial protocol and planned statistical analysis of the LYNX-2 Phase 3 trial of phentolamine ophthalmic solution could adequately address objectives supporting regulatory submission and a potential future marketing application in this indication. LYNX-2 will be a multi-center, randomized, double-masked, placebo-controlled Phase 3 trial designed to evaluate the safety and efficacy of phentolamine ophthalmic solution in up to 200 patients in the United States. The primary endpoint will be a gain of 3 lines (or 15 letters) or more of distance vision improvement on a low contrast chart in dim light conditions after 15 days of dosing.

• LumiThera Inc. announced an update on the regulatory status of the Valeda Light Delivery System. Following feedback from the FDA, a De Novo request to reclassify the Valeda Light Delivery System as a Class II device has been submitted for review. Under the De Novo request process, Valeda can be assigned an official classification as a Class II device with special controls. LumiThera submitted the US LIGHTSITE III clinical data as part of a technical package to the FDA under a Premarket Approval (PMA) application in 2023. The FDA determined the best path to market would be to submit a De Novo request requesting classification of the device as a Class II with special controls. The FDA review time for the De Novo application is 150 days vs 180 days for a PMA, not including additional time for interactive review. The company proposed special controls as part of the De Novo request submission and could anticipate the FDA granting the De Novo request enabling US market introduction by mid-2024 if successful.

• Alimera Sciences completed enrollment for the company’s Synchronicity Study, a prospective, Phase 4 open-label clinical study evaluating the safety and efficacy of YUTIQ (fluocinolone acetonide intravitreal implant 0.18 mg) in the treatment of chronic non-infectious uveitis and related intraocular inflammation. The primary outcome measure for the study is the mean change from baseline in BCVA letter score in the study eye measured by EDTRS at Month 6 and the mean change from baseline central subfield thickness at Month 6. Key secondary endpoints include time to recurrence of non-infectious inflammation in the study eye, presence of vascular leakage, proportion of subjects with resolution of macular edema, mean change from baseline in BCVA letter score and mean change from baseline in central subfield thickness. 

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.