• The FDA granted 510(k) clearance for BELKIN Vision’s Eagle glaucoma laser device. The Eagle device is a Q-switched, 532 nm-wavelength, frequency-doubled Nd:YAG laser that is intended for use in performing selective laser trabeculoplasty (SLT). The laser energy is delivered in a non-contact procedure directly through the limbus to the trabecular meshwork without the need for the use of a gonioscopy lens. In addition, the device automatically defines the target location then applies the laser treatment sequence while the eye tracker compensates for any eye movement. 

• Tarsus Pharmaceuticals announced topline results from the Ersa Phase 2a clinical trial evaluating TP-03 (lotilaner ophthalmic solution, 0.25%) administered twice daily (b.i.d.) or three times a day (t.i.d.) for 12 weeks for the treatment of meibomian gland disease in patients with Demodex mites. TP-03 demonstrated statistically significant and clinically meaningful improvements compared to baseline in two objective measures of the disease — the presence and quality of liquid secretion as measured by the meibomian gland secretion score (MGSS, scoring range of 0-45) and the number of glands secreting normal liquid as measured in the central 15 glands of the lower eyelid. A significant and clinically meaningful increase from baseline was observed in the mean MGSS of 10.5 (±1.6 standard error, SE) and 11.7 (±1.9 SE) for the b.i.d. and t.i.d. arms, respectively, at Day 85 (p < 0.001). The improvement in the mean number of meibomian glands secreting clear liquid from baseline was also statistically significant and clinically meaningful, with an increase of 4.8 (±0.8 SE) and 5.3 (±1.1 SE) glands for the b.i.d. and t.i.d. arms, respectively, at Day 85 (p < 0.001). For more, see the study results here.

• Sight Sciences announced the acceptance for publication in Clinical Ophthalmology of the prospective, multi-center, 3-year GEMINI 2 trial with long-term clinical outcomes for patients treated with the OMNI Surgical System technology. GEMINI 2, a prospective, multi-center, medication washout trial designed to obtain 36-month follow-up for patients treated in the original 12-month GEMINI trial, has been completed. Favorable results demonstrate sustained and clinically significant IOP reduction of greater than 20% and clinically significant IOP-lowering medication reduction at 36 months. Sustained medication reductions at 24 and 36 months were also reported, with 77% of study patients medication-free at 2 years and 74% of study patients medication-free at 3 years post-procedure. For more, see the study results here. 

• Oculis Holding announced “First Patient First Visit” in its Phase 2b RELIEF trial evaluating the potential of licaminlimab (OCS-02), Oculis’ anti-TNFα biologic eyedrop for the treatment of dry eye disease (DED). The trial is a multi-center, randomized, double-masked, vehicle-controlled trial evaluating the safety and efficacy of licaminlimab for the treatment of signs and symptoms in moderate-to-severe DED. The trial will evaluate if patients with a specific genetic biomarker identified in a prior trial respond better to licaminlimab. The trial was designed after several trials with licaminlimab in DED and uveitis demonstrated positive findings. A total of 120 patients are planned to be randomized to either licaminlimab or vehicle for a 6-week treatment and a 2-week follow-up period. Topline results are anticipated in mid-2024.

• ProQR Therapeutics N.V. completed a transaction divesting late-stage ophthalmic assets sepofarsen and ultevursen to Laboratoires Théa (Théa). Théa will continue development of sepofarsen and ultevursen for patients with LCA10 and Usher syndrome. Under the terms of the agreement, ProQR received an initial payment of €8M and may be eligible for up to €165M in further development, regulatory, and commercial earn-out payments upon related achieved milestones, as well as double-digit royalties based on commercial sales in the United States and EU. The transaction supports ProQR’s strategic focus on its proprietary Axiomer RNA editing technology platform and continued advancement of its pipeline.

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.