Ocular Therapeut Stock Price, News & Analysis

Ocular Therapeutix has announced accelerated timelines for its SOL-1 Phase 3 registrational clinical trial of AXPAXLI in wet age-related macular degeneration (wet AMD). The company now expects:

• Full enrollment and randomization by the end of 2024
• Topline data during the fourth quarter of 2025

SOL-1 is a superiority study conducted under a Special Protocol Agreement with the FDA, aiming to randomize approximately 300 subjects. The primary endpoint is the proportion of subjects maintaining visual acuity at Week 36. The ongoing Phase 3 clinical program, including SOL-1 and SOL-R studies, is expected to form the basis for AXPAXLI's regulatory filing for wet AMD treatment.

Ocular Therapeutix (NASDAQ:OCUL), a biopharmaceutical company focused on developing innovative therapies for retinal diseases and other eye conditions, has announced inducement awards for its newly appointed Chief Legal Officer, Todd D.C. Anderman. The awards, granted under Ocular's 2019 Inducement Stock Incentive Plan, include:

1. Non-statutory stock options to purchase up to 296,500 shares of Ocular's common stock at the closing price on October 7, 2024. These options have a ten-year term and vest over four years.

2. Restricted stock unit awards representing 98,700 shares of Ocular's common stock, vesting over three years in equal annual installments.

These inducement equity awards are subject to Mr. Anderman's continued service with Ocular and the terms of the 2019 Inducement Stock Incentive Plan.

Ocular Therapeutix (NASDAQ: OCUL) has announced its participation in the UBS Virtual Opthalmology Day 2024. The event will feature a fireside chat with Pravin U. Dugel, MD, Executive Chairman, President and CEO of Ocular, scheduled for Wednesday, October 2, 2024, at 3:00 PM ET.

The company, which focuses on developing innovative therapies for retinal diseases and other eye conditions, will also host investor meetings during the conference. Interested parties can access a live webcast of the fireside chat through the Investors section of Ocular's website at investors.ocutx.com.

This participation underscores Ocular Therapeutix's commitment to engaging with the investment community and sharing insights about its efforts to improve vision through advanced therapeutics.

Ocular Therapeutix (NASDAQ: OCUL), a biopharmaceutical company focused on developing therapies for retinal diseases and eye conditions, has announced inducement awards for its newly appointed Director of IT Cybersecurity, Russell Isaacs. The awards, granted under Ocular's 2019 Inducement Stock Incentive Plan, include:

1. Non-statutory stock options: 14,000 shares at market price, vesting over four years
2. Restricted stock unit awards: 4,666 shares, vesting over three years

These equity awards are designed to incentivize Mr. Isaacs' employment with Ocular and are subject to his continued service with the company. The grants comply with Nasdaq Listing Rule 5635(c)(4) and were effective as of September 9, 2024.

Ocular Therapeutix (NASDAQ: OCUL) announces multiple presentations at four major retina meetings in Portugal and Spain this September. The presentations focus on their innovative therapies for retinal diseases, particularly the axitinib hydrogel implant (OTX-TKI) for treating neovascular age-related macular degeneration (AMD) and diabetic retinopathy.

Key presentations include:

• 52-week results of OTX-TKI in AMD patients at The Retina Society meeting
• One-year results of OTX-TKI in diabetic retinopathy from the HELIOS Phase 1 trial
• Panel discussions on novel drug delivery approaches for posterior segment diseases
• 48-week safety and efficacy results from the HELIOS trial for non-proliferative diabetic retinopathy

These presentations highlight Ocular's transformation into a retina-focused company and its efforts to change the future paradigm for managing retinal vascular diseases.

Ocular Therapeutix (NASDAQ: OCUL), a biopharmaceutical company focused on improving vision through innovative therapies, has announced its participation in two upcoming investor conferences in September 2024. The company will be present at:

1. The Baird 2024 Global Healthcare Conference on Tuesday, September 10, with a fireside chat scheduled for 12:50 PM ET in New York, NY.

2. The H.C. Wainwright 26th Annual Global Investment Conference on Wednesday, September 11, featuring a fireside chat at 8:30 AM ET, also in New York, NY.

Investors can access a live webcast of the H.C. Wainwright fireside chat through the Investors section of Ocular Therapeutix's website at investors.ocutx.com.

Ocular Therapeutix (NASDAQ: OCUL), a biopharmaceutical company focused on improving vision through innovative therapies, has announced the granting of inducement awards to four newly hired employees. These awards, made under Ocular's 2019 Inducement Stock Incentive Plan, include:

1. Non-statutory stock options to purchase up to 132,400 shares of Ocular's common stock, with a ten-year term and a four-year vesting schedule.

2. Restricted stock unit awards representing the right to receive 44,133 shares of Ocular's common stock, with a three-year vesting schedule.

The grants, effective August 5, 2024, are designed to incentivize new employees and comply with Nasdaq Listing Rule 5635(c)(4).

Ocular Therapeutix (NASDAQ: OCUL) reported Q2 2024 results and provided updates on its AXPAXLI™ wet AMD program. Key highlights include:

1. FDA confirmed SOL-R repeat dosing study is acceptable as a registrational trial
2. SOL-1 enrollment accelerating; SOL-R actively enrolling patients
3. Cash balance of $459.7M as of June 30, 2024, expected to fund operations into 2028
4. Q2 2024 total net revenue: $16.4M, up 8.3% YoY
5. Full-year 2024 DEXTENZA revenue guidance: $62.0M - $67.0M
6. Q2 2024 net loss: $(43.8M) or $(0.26) per share

The company remains focused on becoming a leader in retinal disease treatment, with promising progress in its AXPAXLI clinical trials for wet AMD and NPDR.

Ocular Therapeutix (NASDAQ: OCUL) has received FDA confirmation that its Phase 3 SOL-R clinical trial is suitable as a registrational study for AXPAXLI™ (axitinib intravitreal implant) in treating wet age-related macular degeneration (wet AMD). The FDA agreed that using one superiority study (SOL-1) and one non-inferiority study (SOL-R) is acceptable for a potential New Drug Application. SOL-R evaluates repeat dosing of AXPAXLI every six months compared to standard aflibercept treatment. This development clarifies the regulatory path for AXPAXLI in wet AMD, potentially offering a new treatment paradigm with long-term visual improvements through durable VEGF suppression.