DRY EYE DISEASE PIPELINE UPDATE

BY RENÉ LUTHE, SENIOR EDITOR

Allegro Ophthalmics’ ALG-1007, a topical integrin regulator in development for the treatment of dry eye disease (DED), met all primary and secondary endpoints in a recent ex-US vehicle-controlled study. The study authors determined ALG-1007, a fixed combination of 0.6% risuteganib and 0.125% sodium hyaluronate in a vehicle solution, demonstrated the highest efficacy among four study arms (P<.001) comprising various combinations of the solution components. Patients who received ALG-1007 experienced statistically significant better results in tear break-up time, inferior corneal staining and scores on the dry eye management scale and visual analog scales.

The FDA accepted the filing of an Investigational New Drug application for ALG-1007, paving the way for a Phase 2b clinical trial.

Mimetogen Pharmaceuticals’ tavilermide (MIM-728), a first-in-class nerve growth factor mimetic for the treatment of DED, completed Phase 3 clinical trials in 2020. The trials compared the efficacy of 5% tavilermide and 1% tavilermide ophthalmic solutions to vehicle, each dosed b.i.d. for 12 weeks. Change in eye dryness score as measured by the visual analog scale and change in total corneal fluorescein staining were the primary endpoints.

According to the company, data generated from the studies for 1% tavilermide showed small but significant (p<0.05) treatment effects compared to vehicle in reducing the signs and symptoms of dry eye.

As for 5% tavilermide, the first Phase 3 environmental study to evaluate the safety and efficacy demonstrated statistically significant and clinically relevant improvement in corneal fluorescein at 12 weeks with significant onset of effect observed at 8 weeks, the company reported.

Neuroptika initiated a Phase 2 clinical trial in 2020 to evaluate the safety and efficacy of NRO-1 in patients with moderate-to-severe DED, including postsurgical patients. The controlled, double-masked, randomized trial of its novel therapeutic with the potential to regenerate corneal nerves in ophthalmic diseases compares two concentrations of NRO-1 against vehicle. The endpoints will include standard signs and symptoms characteristic of DED as well as nerve morphology imaging and biomarker analysis, the company reports.

Ocular Therapeutix is developing two therapies to address DED: OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of DED as well as OTX-CSI (cyclosporine intracanalicular insert) for chronic treatment in a Phase 2 clinical trial. The company announced topline results for OTX-DED’s Phase 2 trial, which evaluated two formulations: 0.2 mg (p=.004) and 0.3 mg (p=.028), comparing them to vehicle hydrogel insert. Both showed statistically significant improvement for primary endpoint of bulbar conjunctival hyperemia. Both formulations were observed to have a favorable safety profile and were generally well tolerated.

RegeneRx Biopharmaceuticals is investigating its RGN-259 proprietary eyedrop that demonstrated fast onset efficacy in two Phase 3 clinical trials: ARISE-1 and ARISE-2. It was found to be safe and well-tolerated and has not shown adverse side effects such as eye irritation, stinging and visual disturbance. A third Phase 3 trial, ARISE-3, is ongoing.

Tarsus’ TP-03 (lotilaner ophthalmic solution 0.25%) was developed for the treatment of Demodex blepharitis. According to Saturn-1 Phase 2b/3 trial results, the drug achieved all primary and secondary endpoints. Additionally, 95% of patients treated achieved ≤0.5 mites per lash at day 43 from an average baseline of 3.2 mites per lash compared to 36% of patients on vehicle, with statistically significant results seen as soon as day 15; 93% improved at least one collarette grade. It also showed a favorable safety profile for the drug with no clinically significant effect on multiple measures, including IOP. Results from a second Phase 3 study are expected this spring. If approved, TP-03 will be the first FDA-approved therapy for Demodex blepharitis.

TearSolutions is preparing to conduct two Phase 3 pivotal trials for Lacripep, a first-in-class topical synthetic peptide treatment for dry eye. The first trial will be a multi-part Phase 2/3 trial where one study will be conducted in patients with DED associated with primary Sjögren’s Syndrome (pSS). The second Phase 3 trial will be in a general, potentially less severe, DED population that will not exclude pSS patients. The company plans first enrollment for the first Phase 3 trial in July 2022. OM

For discussion on other pipeline medications coming soon, including Aldeyra’s Reproxalap and B+L/Novaliq’s NOV03, click here.

WHAT’S NEW IN DRY EYE/OSD

BY JULIE GREENBAUM, ASSOCIATE EDITOR

Alcon introduced its latest dry eye solution, the Systane iLux2 Meibomian Gland Dysfunction (MGD) Thermal Pulsation System. The handheld device allows practitioners to tailor MGD treatment to the needs of each of their patients in 8 to 12 minutes. The device’s imaging technology allows patients to view both their meibomian glands and treatment through infrared imaging and HD video of the procedure. Practitioners can customize heat and compression across each easy-to-visualize treatment zone.

I-MED Pharma and NTC Srl announced that I-Defense, a lubricating ointment containing 0.4% sodium hyaluronate indicated for the relief of dry eyes and lagophthalmos symptoms, has been successfully registered with the FDA.

The FDA granted Olympic Ophthalmics 510(K) request for its second-generation iTEAR100 device, a prescription neuromodulation therapy to acutely increase tear production in adult patients over a 30-day period. The second-generation connected device offers telehealth tools, including prescription download capability and activation through a mobile phone app. Ongoing innovations to the platform will layer in additional diagnostic capabilities and disease management features for a complete telehealth solution.

Quantel Medical, a fully-owned subsidiary of the Lumibird Group, launched the C.STIM IPL system to treat DED. The system is based on intense pulsed light technology and provides a safe and effective treatment for phototypes 1 to 5. Some of the features of the C.STIM IPL include: an ergonomic design for ease of use, an intuitive interface with HD screen, a handpiece with integrated water-based cooling for precise treatment and a trolley with multiple storage areas. The company also launched a new dry eye information website for patients, www.mydryeyedisease.com .

Sight Sciences received FDA 510(k) clearance of the TearCare System for the treatment of MGD. The indication clears TearCare for the application of localized heat therapy in adult patients with evaporative DED due to MGD when used in conjunction with manual expression of the meibomian glands. Sight Sciences plans to continue research efforts to help support future indications for the TearCare System and to provide additional randomized, controlled clinical data, which the company believes could help support insurance coverage for the procedure in the future.

Sun Pharma shared results from a study on CEQUA (cyclosporine ophthalmic solution) published in Current Eye Research. The paper pooled analysis of Phase 2b/3 and Phase 3 studies and examined the effect of CEQUA (OTX-101) on tear production in patients with severe tear-deficient DED. The authors concluded that OTX-101 administered twice daily for 84 days significantly improved tear production vs vehicle in patients with severely impaired tear production.

Théa Pharma completed its acquisition of seven branded ophthalmic products from Akorn: Zioptan, Cosopt, Cosopt PF, Betimol along with Azasite, Akten and the ocular surface repair agent, AcellFX. Additionally, Théa began the launch activities for its evidence-based line of iVizia OTC products for dry eye and eyelid hygiene being distributed by Similasan Corp.

ThermaMEDx launched EverTears, the first self-healing, pre-moistened, disposable, sterile cleaning eye-pad for use in treating the symptoms of dry eyes and MGD. EverTears is available without a prescription from eye doctors nationwide.