FDA approves dry eye drop targeting tear evaporation

Bausch + Lomb announced FDA approval of MIEBO (formerly called NOV03, perfluorohexyloctane ophthalmic solution) for the signs and symptoms of dry eye disease. According to the company, this drop is the first and only topical FDA-approved treatment addressing tear evaporation. Two Phase 3 pivotal clinical trials involving more than 1,200 participants, who were randomized 1:1 to receive either MIEBO or hypotonic saline, saw MIEBO achieving its primary clinical sign (change from baseline in total corneal fluorescein staining) and patient-reported symptoms (eye dryness based on the Visual Analog Scale) endpoints. According to the company, patients began experiencing symptom relief as early as day 15 and through day 57 of the study. The most common adverse reactions were blurred vision (1.3–3%) and eye redness (1–3%).

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Topline results from Phase 3 trial of eye drops for DME

Oculis announced topline results from stage 1 of its Phase 3 trial of OCS-01 as a drop for treatment of diabetic macular edema. According to the company, OCS-01 is a novel, topical, high concentration of dexamethasone (15 mg/ml). The press release stated that the study randomized 148 patients 2:1 to receive OCS-01 or vehicle six times a day for 6 weeks followed by three times a day for an additional 6 weeks. The primary endpoint of statistically significant improvement in mean BCVA from baseline to week 6 was met. The company reported an improvement of 7.2 letters in the OCS-01 group and 3.1 letters in the vehicle group, which was continued to week 12. The company also reported a higher percentage of patients in the treatment group achieving a 15 or more letter improvement in BCVA from baseline at week 6 than those in the vehicle group. The treatment was well tolerated with no unexpected adverse events, according to Oculis. In the second half of this year, the company will move onto stage 2 of the study, which Oculis described as two global trials that will each enroll between 350–450 patients.

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Investigational intravitreal gene therapy program introduced for geographic atrophy

Adverum Biotechnologies introduced a new gene therapy program under investigation for treatment of geographic atrophy. According to the company, the program involves Complement Factor I (CFI), which is a component in the complement cascade for this condition. The company reported that at this stage, the intravitreal treatment, which was administered in an animal model with two capsid methods, showed tolerance in non-human primates.

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Phase 1 study for periocular drug for wet AMD and DME begins

AiViva BioPharma announced that it has begun a Phase 1 trial for a drug delivered periocularly for treatment of wet AMD and DME. The trial, taking place in the U.S., is for AIV007, which is a broad spectrum tyrosine kinase inhibitor, according to the company’s press release. The Phase 1 trial is a multicenter, open-label, dose-escalation safety study. It will enroll up to 24 patients for a single periocular injection followed by monthly evaluations for 6 months.

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Commercial rights for uveitis treatment acquired

Alimera Sciences has acquired additional commercial rights, including exclusive commercial rights in the U.S., for YUTIQ (fluocinolone acetonide intravitreal insert) for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye from EyePoint Pharmaceuticals. According to the company’s press release, Alimera Sciences now has exclusive global rights, excluding in China, Hong Kong, Taiwan, Macau, South Korea, and Southeast Asia.

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ASCRS news and events

• ASCRS Summer Meeting: The ASCRS Summer Meeting in Nashville, Tennessee, returns August 11–13. Early bird registration pricing is ongoing through June 26.
• Cataract Awareness Month: Coming up in June, ASCRS will recognize Cataract Awareness Month. Follow ASCRS on social media to keep up with the latest on this important awareness effort.

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Research highlights

• A single-center, prospective, placebo-controlled, crossover trial sought to evaluate the stopping and reversal of glaucoma therapy-related ocular surface disease when patients were switched from a preserved latanoprost and dorzolamide/timolol fixed combination (DTFC) to preservative-free tafluprost and DTFC with cyclosporine or with placebo. After 6 months patients were switched to the opposite regimen. According to the paper published in the journal Eye, 41 patients who were well controlled on their preserved medications with open angle glaucoma were enrolled. Overall, preservative-free therapy improved the prior glaucoma treatment-related OSD. The group that also received cyclosporine saw greater improvements in MMP-9 and tear film breakup time, compared to placebo, as well as a superior mean Oxford score. The authors also wrote that the cyclosporine group was superior to placebo in terms of relieving feelings of itchiness and had fewer objective adverse events; however, it did have more stinging. Both preservative-free regimens reduced IOP more than the preserved therapy as well.
• A prospective study published in the Journal of Cataract & Refractive Surgery evaluated different IOL formulas in eyes that had prior small incision lenticule extraction (SMILE). Preoperative measurements for IOL power calculations were taken before and after SMILE. The authors concluded that the Haigis formula in combination with total keratometry, Okulix, and the Barrett True-K with and without total keratometry yielded the most accurate IOL power calculations after SMILE. The authors reported a tendency for myopic shift with the Haigis-L in eyes after SMILE.

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